Rule: Combat Methamphetamine Epidemic Act of 2005: Scheduled Listed Chemical Products Retail Sales Requirements

56008 Federal Register / Vol. 71, No.
186 / Tuesday, September 26, 2006 / Rules and Regulations
The basis of approval is discussed in the DEPARTMENT OF JUSTICE document is also available at the http://
freedom of information summary. www.regulations.gov Web site. DEA will
Drug Enforcement Administration accept attachments to electronic
In addition, FDA is amending
§ 558.311 to remove redundant text in comments in Microsoft word,
21 CFR Parts 1300, 1309, 1310, 1314 WordPerfect, Adobe PDF, or Excel file
an entry for combination use of single-
[Docket No. DEA–291I] formats only. DEA will not accept any
ingredient lasalocid and
file format other than those specifically
chlortetracycline in cattle feed which RIN 1117–AB05 listed here.
was published in error in the Federal
FOR FURTHER INFORMATION CONTACT:
Register of April 27, 2006 (71 FR Retail Sales of Scheduled Listed
Chemical Products; Self-Certification Mark W. Caverly, Chief, Liaison and
24816). This correction is being made to
of Regulated Sellers of Scheduled Policy Section, Office of Diversion
improve the accuracy of the regulations.
Listed Chemical Products Control, Drug Enforcement
Approval of this supplemental NADA Administration, Washington, DC 20537;
did not require review of additional AGENCY: Drug Enforcement telephone: (202) 307–7297.
safety or effectiveness data or Administration (DEA), Justice. SUPPLEMENTARY INFORMATION:
information. Therefore, a freedom of ACTION: Interim final rule with request
information summary is not required. for comment. DEA’s Legal Authority
The agency has determined under 21 DEA implements the Comprehensive
SUMMARY: In March 2006, the President Drug Abuse Prevention and Control Act
CFR 25.33(a)(6) that this action is of a signed the Combat Methamphetamine
type that does not individually or of 1970, often referred to as the
Epidemic Act of 2005, which establishes Controlled Substances Act (CSA) and
cumulatively have a significant effect on new requirements for retail sales of
the human environment. Therefore, the Controlled Substances Import and
over-the-counter (nonprescription) Export Act (21 U.S.C. 801–971), as
neither an environmental assessment products containing the List I chemicals amended. DEA publishes the
nor an environmental impact statement ephedrine, pseudoephedrine, and implementing regulations for these
is required. phenylpropanolamine. The three statutes in Title 21 of the Code of
This rule does not meet the definition chemicals can be used to manufacture Federal Regulations (CFR), Parts 1300 to
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because methamphetamine illegally. DEA is 1399. These regulations are designed to
it is a rule of ‘‘particular applicability.’’ promulgating this rule to incorporate ensure that there is a sufficient supply
Therefore, it is not subject to the the statutory provisions and make its of controlled substances for legitimate
congressional review requirements in 5 regulations consistent with the new medical, scientific, research, and
U.S.C. 801–808. requirements. This action establishes industrial purposes and to deter the
daily and 30-day limits on the sales of diversion of controlled substances to
List of Subjects in 21 CFR Part 558 scheduled listed chemical products to illegal purposes. The CSA mandates that
individuals and requires recordkeeping DEA establish a closed system of control
Animal drugs, Animal feeds. on most sales. for manufacturing, distributing, and
■ Therefore, under the Federal Food, DATES: Effective Dates: September 21, dispensing controlled substances. Any
Drug, and Cosmetic Act and under 2006, except that §§ 1314.20, 1314.25, person who manufactures, distributes,
authority delegated to the Commissioner and 1314.30 (with the exception of dispenses, imports, exports, or conducts
of Food and Drugs and redelegated to § 1314.30(a)(2)) are effective September research or chemical analysis with
the Center for Veterinary Medicine, 21 30, 2006. Section 1314.30(a)(2) is controlled substances must register with
CFR part 558 is amended as follows: effective November 27, 2006. DEA (unless exempt) and comply with
Comment Date: Written comments the applicable requirements for the
PART 558—NEW ANIMAL DRUGS FOR must be postmarked on or before activity. The CSA as amended also
USE IN ANIMAL FEEDS November 27, 2006. requires DEA to regulate the
ADDRESSES: To ensure proper handling manufacture and distribution of
■ 1. The authority citation for 21 CFR of comments, please reference ‘‘Docket chemicals that may be used to
part 558 continues to read as follows: No. DEA–291I’’ on all written and manufacture controlled substances
electronic correspondence. Written illegally. Listed chemicals that are
Authority: 21 U.S.C. 360b, 371.
comments being sent via regular mail classified as List I chemicals are
§ 558.311 [Amended] should be sent to the Deputy important to the manufacture of
Administrator, Drug Enforcement controlled substances. Those classified
■ 2. In § 558.311, in paragraph (b)(8), Administration, Washington, DC 20537, as List II chemicals may be used to
after the number ‘‘15’’ add the words Attention: DEA Federal Register manufacture controlled substances.
‘‘and 20’’; and in paragraph (e)(1)(xxvii) Representative/ODL. Written comments On March 9, 2006, the President
in the ‘‘Indications for use’’ column, sent via express mail should be sent to signed the Combat Methamphetamine
remove ‘‘control of control of’’ and in its DEA Headquarters, Attention: DEA Epidemic Act of 2005 (CMEA), which is
place add ‘‘control of’’. Federal Register Representative/ODL, Title VII of the USA PATRIOT
Dated: September 15, 2006. 2401 Jefferson-Davis Highway, Improvement and Reauthorization Act
Alexandria, VA 22301. Comments may of 2005 (Pub. L. 109–177). DEA is
Steven D. Vaughn,
be directly sent to DEA electronically by promulgating this rule as an interim
Director, Office of New Animal Drug sending an electronic message to final rule rather than a proposed rule
Evaluation, Center for Veterinary Medicine. dea.diversion.policy@usdoj.gov. because the changes being made codify
rmajette on PROD1PC67 with RULES1
[FR Doc. 06–8261 Filed 9–25–06; 8:45 am] Comments may also be sent statutory provisions, some of which are
BILLING CODE 4160–01–S electronically through http:// already in effect. Parts of the statute are
www.regulations.gov using the self-implementing; certain changes
electronic comment form provided on related to retail sales became effective
that site. An electronic copy of this upon signature (March 9, 2006), others
VerDate Aug<31>2005 14:57 Sep 25, 2006 Jkt 208001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\26SER1.SGM 26SER1
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations 56009
became effective on April 8, 2006, and hemorrhagic stroke. In response, many Congress determined that the existing
still others will become effective companies voluntarily reformulated limits were not sufficient to prevent
September 30, 2006. An agency may their products to exclude people from buying these products and
find good cause to exempt a rule from phenylpropanolamine. Subsequently, using them to illegally manufacture
certain provisions of the Administrative on December 22, 2005, FDA published methamphetamine. In the Combat
Procedure Act (APA) (5 U.S.C. 553), a Notice of Proposed Rulemaking (70 FR Methamphetamine Epidemic Act of
including notice of proposed 75988) proposing to categorize all over- 2005, Congress adopted provisions that
rulemaking and the opportunity for the-counter nasal decongestants and do the following:
public comment, if it is determined to weight control drug products containing • Limit the quantity of each of the
be unnecessary, impracticable, or phenylpropanolamine preparations as chemicals that may be sold to an
contrary to the public interest. Many of Category II, nonmonograph, i.e., not individual in a day to 3.6 grams of the
the requirements of the Combat generally recognized as being safe for chemical, without regard to the number
Methamphetamine Epidemic Act of human consumption. Most products of transactions.
2005 included in this rulemaking were containing phenylpropanolamine • For nonliquids, limit packaging to
set out in such detail as to be self- intended for humans have been blister packs containing no more than 2
implementing. Therefore the changes in withdrawn from the market, but dosage units per blister. Where blister
this rulemaking provide conforming phenylpropanolamine is still sold by packs are not technically feasible, the
amendments to make the language of prescription for veterinary uses. product must be packaged in unit dose
the regulations consistent with that of Under previous CSA amendments packets or pouches.
the law. DEA is accepting comments on (the Comprehensive Methamphetamine
• Require regulated sellers to place
other aspects of this rulemaking, Control Act of 1996 (MCA) and the
the products behind the counter or in
particularly those not specifically Methamphetamine Anti-Proliferation
locked cabinets.
mandated by the Combat Act of 2000 (MAPA)), Congress limited
the quantity of products containing • Require regulated sellers to check
Methamphetamine Epidemic Act of the identity of purchasers and maintain
2005. ephedrine, pseudoephedrine, and
phenylpropanolamine that could be a log of each sale that includes the
Combat Methamphetamine Epidemic sold as nonprescription drugs at retail purchaser’s name and address, signature
Act of 2005 (which were, along with certain liquid of the purchaser, product sold, quantity
The Combat Methamphetamine products, defined as ‘‘ordinary over-the- sold, date, and time.
Epidemic Act of 2005 (CMEA) amends counter pseudoephedrine or • Require regulated sellers to
the CSA to change the regulations for phenylpropanolamine products’’) maintain the logbook for at least two
selling nonprescription products that without recordkeeping, but generally years.
contain ephedrine, pseudoephedrine, exempted products sold in blister packs • Require regulated sellers to train
and phenylpropanolamine, their salts, sold by ‘‘retail distributors’’. The MCA employees in the requirements of the
optical isomers, and salts of optical established thresholds for these drug law and certify to DEA that the training
isomers. CMEA creates a new category products, including a threshold of 24 has occurred.
of products called ‘‘scheduled listed grams of combination ephedrine • For mobile retail vendors and mail
chemical products.’’ Ephedrine, products; single-entity ephedrine order sales, require sellers to limit sales
pseudoephedrine, and products had been regulated by the to an individual in a 30-day period to
phenylpropanolamine are List I Domestic Chemical Diversion Control 7.5 grams.
chemicals because they are used in, and Act of 1993 (Pub. L. 103–200). MAPA • For individuals, limit purchases in
important to, the illegal manufacture of reduced existing thresholds for a 30-day period to 9 grams, of which not
methamphetamine. Products containing pseudoephedrine and more than 7.5 grams may be imported
these List I chemicals also have phenylpropanolamine to 9 grams per by means of a common or contract
legitimate medical uses. Ephedrine is transaction, with each package carrier or the U.S. Postal Service.
used in some products for treating containing not more than 3 grams of The numbers of dosage units and
asthma. Pseudoephedrine, a pseudoephedrine base or milliliters (mL) that may be purchased
decongestant, is a common ingredient in phenylpropanolamine base, but retained under the sales limits are shown in
cold and allergy medications. In the so-called ‘‘blister pack’’ exemption. Table 1 below. As noted previously, the
November 2000, the Food and Drug Because most retail outlets did not want FDA issued a voluntary recall on
Administration (FDA) issued a public to create and maintain records of sales phenylpropanolamine products as being
health advisory concerning or register as a retail distributor, the unsafe for humans so no
phenylpropanolamine and requested threshold for recordkeeping functioned phenylpropanolamine over-the-counter
that all drug companies discontinue for practical purposes similarly to a (OTC) product should be available for
marketing products containing sales limit. Much of the product was human consumption. Veterinary use is
phenylpropanolamine due to risk of also sold in blister packs. by prescription only.
TABLE 1.—NUMBER OF TABLETS/MILLILITERS THAT EQUAL RETAIL TRANSACTION LIMITS (AS BASE) FOR SCHEDULED
LISTED CHEMICAL PRODUCTS
Transaction limits
Scheduled listed chemical product
3.6 gm 7.5 gm 9.0 gm
Tablets
Ephedrine:
25 mg Ephedrine HCl ................................................................................................................................... 175 366 439
25 mg Ephedrine Sulfate .............................................................................................................................. 186 389 466
Pseudoephedrine (as HCl):
56010 Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations
TABLE 1.—NUMBER OF TABLETS/MILLILITERS THAT EQUAL RETAIL TRANSACTION LIMITS (AS BASE) FOR SCHEDULED
LISTED CHEMICAL PRODUCTS—Continued
Transaction limits
Scheduled listed chemical product
3.6 gm 7.5 gm 9.0 gm
30 mg Pseudoephedrine HCl ....................................................................................................................... 146 305 366

60 mg Pseudoephedrine HCl ....................................................................................................................... 73 152 183
120 mg Pseudoephedrine HCl ..................................................................................................................... 36 76 91
Pseudoephedrine (as Sulfate):
30 mg Pseudoephedrine Sulfate .................................................................................................................. 155 324 389
60 mg Pseudoephedrine Sulfate .................................................................................................................. 77 162 194
120 mg Pseudoephedrine Sulfate ................................................................................................................ 38 81 97
240 mg Pseudoephedrine Sulfate ................................................................................................................ 19 40 48
Number of mL
Ephedrine:
6.25 mg/5 ml Ephedrine HCl ........................................................................................................................ 3,515 7,323 8,788
Pseudoephedrine (as HCl):
15 mg/1.6 mL Pseudoephedrine HCl ........................................................................................................... 468 976 1,171
7.5 mg/5 mL Pseudoephedrine HCl ............................................................................................................. 2,929 6,103 7,323
15 mg/5 mL Pseudoephedrine HCl .............................................................................................................. 1,464 3,051 3,661
15 mg/2.5 mL Pseudoephedrine HCl ........................................................................................................... 732 1,525 1,830
30 mg/5 mL Pseudoephedrine HCl .............................................................................................................. 732 1,525 1,830
30 mg/2.5 mL Pseudoephedrine HCl ........................................................................................................... 366 762 915
60 mg/5 mL Pseudoephedrine HCl .............................................................................................................. 366 762 915
Provisions of CMEA a purchaser drug products containing January 14, 2004; corrected at 69 FR
Overview. Before CMEA, requirements more than a threshold quantity (9 grams 3198, January 22, 2004). Either type of
for sales of products containing for pseudoephedrine and seller had to register with DEA if they
ephedrine, pseudoephedrine, and phenylpropanolamine (maximum per sold the products to individuals in
phenylpropanolamine, which were then package of 3 grams), 24 grams for amounts above the threshold quantity.
called regulated drug products or drug ephedrine combination products), Only two persons are registered as retail
products regulated pursuant to 21 CFR regardless of how the products were distributors.
1300.02(b)(28)(i)(D), distinguished packaged. Retailers conducting face-to- The CMEA provisions on retail sales
between in-person sales to a purchaser face transactions had to maintain create differing requirements for the
(retail distribution) and mail order sales, records for sales above the same various types of retail sales. As
which covered any sale where the thresholds except that, as noted above, discussed further below, Table 2
product is shipped using the Postal sales of products in blister packs summarizes the applicability of the
Service or any common or private generally were not covered. The status CMEA provisions as well as existing
carrier. Mail order sellers had to file of such sales was discussed in detail in DEA provisions to the different types of
monthly reports with DEA if they sold an interpretive rule (69 FR 2862, sellers.
TABLE 2.—SUMMARY OF REQUIREMENTS BY TYPE OF SELLER

Regulated sellers Mobile retail Mail order sellers
(store) vendors
Daily sales limit ..................................................................................................... 3.6 gm/chemical .... 3.6 gm/chemical .... 3.6 gm/chemical.
30-day sales limit .................................................................................................. ............................... 7.5 gm ................... 7.5 gm.
Blister packs ......................................................................................................... Yes ........................ Yes ........................ Yes.
Storage ................................................................................................................. Behind the counter Locked cabinet ...... NA.
Locked cabinet.
Logbook ................................................................................................................ Yes ........................ Yes ........................ NA.
Customer ID .......................................................................................................... Examine photo ID Examine photo ID Verify ID.
Train employees ................................................................................................... Yes ........................ Yes ........................ NA.
Self-Certify ............................................................................................................ Yes ........................ Yes ........................ NA.
Notice of misrepresentation .................................................................................. Yes ........................ Yes ........................ NA.
Monthly reports ..................................................................................................... No .......................... No .......................... Yes.
Theft and loss reports ........................................................................................... Yes ........................ Yes ........................ Yes.
CMEA defines nonprescription drug a permanent store or movable site (e.g., have been trained. These sellers, called
products containing ephedrine, kiosk, flea market), are subject to new ‘‘regulated sellers’’ in CMEA, must also
pseudoephedrine, or requirements for training of employees check photo identifications of

phenylpropanolamine as ‘‘scheduled who take part in the sale of scheduled purchasers and maintain specific
listed chemical products.’’ Direct, in- listed chemical products and records of each sale of scheduled listed
person sales to a customer, whether at certification to DEA that the employees chemical products. Under CMEA, the
only sales exempt from recordkeeping ephedrine, pseudoephedrine, or but will be addressed in other
are sales of single packages of phenylpropanolamine and is marketed rulemakings DEA is promulgating to
pseudoephedrine where the package lawfully under the Federal Food, Drug, implement the various provisions of the
contains not more than 60 milligrams. and Cosmetic Act. References to Combat Methamphetamine Epidemic
DEA will issue future guidance to ephedrine, pseudoephedrine, or Act of 2005. In other rulemakings based
further clarify remaining questions phenylpropanolamine include their on new CMEA provisions, imports,
about how regulated entities may meet salts, optical isomers, and salts of other than this 30-day individual limit,
this regulation’s training requirements. optical isomers. CMEA exempts are limited to DEA registrants that have
The recordkeeping and reporting scheduled listed chemical products sold been issued a quota to import. (These
requirements for mail order sales at retail by a regulated seller or by rulemakings will be separately
basically remain the same as under the persons that sell the product for published in the Federal Register.) A
previous regulations, except that a personal use and ship the product by purchaser who violates these limits is
waiver in the prior law that covered non mail or private or common carriers (mail subject to criminal penalties.
face-to-face distributions by retail order sellers) from the definition of Thirty-day limit. CMEA creates a 30-
distributors has been eliminated for regulated transaction. It also removes day sales limit. DEA interprets this to
scheduled listed chemical products. As other references to the sale of these mean a rolling calendar where the sales
a result, retail stores that deliver these chemicals in drug products from the limit is based on sales to the purchaser
products to customers by mail or definition of regulated transactions. in the previous 30 days. DEA interprets
delivery services will need to comply DEA notes that further clarification the per day limit to refer to midnight to
with the provisions for mail order sales regarding regulated transactions will be midnight, not a rolling 24-hour clock.
reporting for these transactions. Mail addressed in a separate rulemaking. Blister packs. Effective April 8, 2006,
order sellers must file monthly reports These changes remove retail sellers and nonliquid forms of scheduled listed
with DEA. CMEA adds the requirement mail order sellers from the registration chemical products (including gel
that these sellers verify the purchaser’s system; in practice, retail and mail order capsules) must be sold only in blister
identity prior to shipping. sellers have not registered because they packs, with no more than two dosage
As noted above, CMEA changes the limited sales to below threshold units per blister unless blister packs are
limits on retail sales. Daily sales are quantities and to products sold in blister technically infeasible. In that case, the
now limited to a maximum of 3.6 grams packs. At present, only two persons are dosage units must be in unit dose
of each chemical in scheduled listed registered as retail distributors. packets or pouches.
chemical products. Mobile retail CMEA adds definitions of ‘‘regulated Product placement: Behind counter or
vendors and mail order vendors must seller,’’ to mean a retail distributor locked cabinet. CMEA requires that on
also limit sales to an individual (including a pharmacy and mobile retail and after September 30, 2006, scheduled
purchaser to 7.5 grams of each chemical vendors), and ‘‘at retail,’’ to mean sale listed chemical products must be stored
in scheduled listed chemical products or purchase for personal use. It also behind the counter or, if in an area
in any 30-day period. CMEA limits revises the definition of ‘‘retail where the public has access, in a locked
purchases by an individual purchaser to distributor’’ to remove the sentence cabinet. Although DEA is not including
9 grams of each chemical in scheduled referring to below threshold quantities. cabinet specifications in the rule, a
listed chemical products in any 30-day This change subjects all sales, except for locked cabinet should be substantial
period, not more than 7.5 grams of sales of single packages containing not enough that it cannot be easily picked
which may be imported by means of a more than 60 milligrams of up and removed. In a store setting, the
private or commercial carrier or the U.S. pseudoephedrine, to recordkeeping cabinet should be similar to those used
Postal Service. Any imports of requirements. to store items, such as cigarettes, that
scheduled listed chemical products Sales limits. Effective April 8, 2006, can be accessed only by sales staff.
subject to the 7.5 gram purchase limit CMEA limits sales to an individual to Logbooks. CMEA requires retail
under CMEA must also otherwise 3.6 grams per day of each chemical in sellers to maintain logbooks on and after
comply with all other applicable scheduled listed chemical products September 30, 2006. If a retailer
Federal and State laws regarding their regardless of the number of purchases. maintains the logbook on paper, DEA is
importation, including the Federal, Mobile retail vendors and mail order requiring that the logbook be bound, as
Food, Drug, and Cosmetic Act. This sellers may not sell an individual more is currently the case for records of sales
provision is not included in this rule, than 7.5 grams of each chemical in of Schedule V controlled substances
but will be addressed in other scheduled listed chemical products in a that are sold without a prescription.
rulemakings DEA is promulgating to 30-day period. A seller who violates Bound blank logbooks and ledger books
implement the various provisions of the these provisions is subject to civil meeting DEA’s regulatory requirements
Combat Methamphetamine Epidemic penalties and possible criminal are readily available on the commercial
Act of 2005. Finally, CMEA exempts all penalties. market. If the logbook is maintained
retail sellers and mail order distributors Purchase limits. CMEA imposes a 9 electronically, the records must be
selling the products at retail from gram purchase limit in a 30-day period readily retrievable by the seller and any
registration. The following sections on individuals. Not more than 7.5 grams DEA or other authorized law
discuss each of the statutory provisions of the 9 grams may be imported by enforcement official. Logs must be kept
in more detail. means of common/contract carrier or for two years from the date the entry
Definitions. CMEA revises the the U.S. Postal Service. Any imports of was made. The logs must include the
definition of ‘‘regulated transaction,’’ scheduled listed chemical products information entered by the purchaser
adds several new definitions, and subject to the 7.5 gram purchase limit (name, address, signature, date, and
removes the definition of ‘‘ordinary under CMEA must also otherwise time of sale) and the quantity and form
over-the-counter pseudoephedrine or comply with all other applicable of the product sold.
phenylpropanolamine product.’’ CMEA Federal and State laws regarding their Where the record is entered
adds a definition of ‘‘scheduled listed importation, including the Federal, electronically, the computer system may
chemical product,’’ which means any Food, Drug, and Cosmetic Act. This enter the date and time automatically.
nonprescription product that contains provision is not included in this rule, An electronic signature system, such as
the ones many stores use for credit card shall be included such as: Name, date of regulated person, as defined in the Act,
purchases, may be employed to capture birth, sex, height, color of eyes, and who engages in a transaction that
the signature for electronic logs. The address. involves ephedrine, pseudoephedrine,
information that the seller must enter • School identification card with a or phenylpropanolamine (including
may be accomplished through a point- photograph. drug products containing these
of-sales system and bar code reader. • Voter’s registration card. chemicals) and uses or attempts to use
DEA is aware that in some cases, such • U.S. military card or draft record. the Postal Service or any private or
as pharmacy counters where the • Identification card issued by commercial carrier shall, on a monthly
computer is behind the pharmacy Federal, State, or local government basis, submit a report of each
counter, it may be difficult for the agencies or entities. If the identification transaction conducted during the
purchaser to enter the information card does not contain a photograph, previous month to DEA. Data contained
electronically. DEA is seeking identifying information shall be in the report includes, but is not limited
comments on whether systems currently included such as: Name, date of birth, to: Name of purchaser; quantity and
used to capture signatures for credit or sex, height, color of eyes, and address. form of ephedrine, pseudoephedrine, or
debit card purchases can be • Military dependent’s identification phenylpropanolamine purchased; and
reprogrammed to allow customers to card. the address to which such ephedrine,
enter name and address, as well as the • Native American tribal documents. pseudoephedrine, or
signature. DEA also recognizes that • United States Coast Guard phenylpropanolamine was sent. DEA
some purchasers will find it difficult or Merchant Mariner Card. has specified further information
impossible to enter the information • Driver’s license issued by a regarding mail order reports by
themselves. In these cases, the seller Canadian government authority. regulation (21 CFR 1310.05).
should ask for the name and address For individuals under age 18 who are CMEA requires that effective April 8,
and enter it, rather than simply copy it unable to produce a document from the 2006, the mail order seller confirm the
off the photo ID. Regardless of how the list above of acceptable documents for identity of the purchaser prior to
information is entered, however, there persons age 16 years and older: shipping the product. CMEA requires
must be a mechanism to allow the • School record or report card. DEA to establish procedures for this
customer to sign the logbook. • Clinic doctor or hospital record. identity verification by regulation. To
Verification of photo ID. CMEA • Daycare or nursery school record. parallel the identification requirements
requires on and after September 30, The list of acceptable forms of for regulated sellers, and to provide
2006, that an individual must present an identification, as cited in CMEA, may reasonable assurance that the person
identification card that includes a change (‘‘in effect on or after the date of purchasing the product is who they
photograph and is issued by a State or enactment’’). DEA has no discretion to claim to be, DEA is requiring that mail
the Federal government or a document alter the list. order sellers verify the identity of the
considered acceptable under 8 CFR Notice on misrepresentations. CMEA purchaser by obtaining a copy of an
274a.2(b)(1)(v)(A) and (B). Those requires that on and after September 30, identification card that includes a
documents currently include the 2006, the logbooks include a notice to photograph and is issued by a State or
following: purchasers that entering false statements the Federal government or a document
• United States passport (unexpired or misrepresentations may subject the considered acceptable under 8 CFR
or expired). purchaser to criminal penalties under 274a.2(b)(1)(v)(A) and (B). Such a copy
• Alien Registration Receipt Card or section 1001 of title 18 of the U.S. Code. may be obtained through use of the
Permanent Resident Card, Form I–551. DEA is requiring the inclusion of the Postal Service, facsimile transmission of
• An unexpired foreign passport that following language in all logbooks: a photocopy, or the scanning and
contains a temporary I–551 stamp. transmission of the identification card,
Warning: Section 1001 of Title 18, United
• An unexpired Employment among other examples. The mail order
States Code, states that whoever, with respect
Authorization Document issued by the to the logbook, knowingly and willfully seller must determine that the name and
Immigration And Naturalization Service falsifies, conceals, or covers up by any trick, address on the identification card
which contains a photograph, Form I– scheme, or device a material fact, or makes correspond to the name and address
766; Form I–688, Form I–688A, or Form any materially false, fictitious, or fraudulent provided to the mail order seller as part
I–688B. statement or representation, or makes or uses of the sales transaction. If the
• In the case of a nonimmigrant alien any false writing or document knowing the information cannot be confirmed, the
authorized to work for a specific same to contain any materially false, seller may not ship the items.
employer incident to status, an fictitious, or fraudulent statement or entry, Selling at retail. CMEA requires that
unexpired foreign passport with an shall be fined not more than $250,000 if an
on and after September 30, 2006, a
individual or $500,000 if an organization,
Arrival-Departure Record, Form I–94, regulated seller must not sell scheduled
imprisoned not more than five years, or both.
bearing the same name as the passport listed chemical products unless it has
and containing an endorsement of the With both a bound logbook and self-certified to DEA, through DEA’s
alien’s nonimmigrant status, so long as electronic log, inclusion of this notice Web site. The self-certification requires
the period of endorsement has not yet may present difficulties. If the purchaser the regulated seller to confirm the
expired and the proposed employment is not able to enter the information following:
is not in conflict with any restrictions or electronically in a store, providing the • Its employees who will be engaged
limitations identified on the Form I–94. notice electronically will not meet the in the sale of scheduled listed chemical
For individuals 16 years of age or requirements. If not feasible in these products have undergone training
older: situations, one alternative is that the regarding provisions of CMEA.
• A driver’s license or identification seller prominently display the notice • Records of the training are
card containing a photograph, issued by where the purchaser will see it when maintained.
a State or an outlying possession of the entering or providing the information. • Sales to individuals do not exceed
United States. If the driver’s license or Verification of identity for mail order 3.6 grams of ephedrine,
identification card does not contain a sales. The Controlled Substances Act pseudoephedrine, or
photograph, identifying information (21 U.S.C. § 830(b)(3)) requires that each phenylpropanolamine per day. (Mobile
retail vendors must also confirm that regulated sellers will be classified into proposing that regulated sellers who are
sales to an individual in a 30-day period three categories: Chain stores that are not DEA registrants pay a fee for self-
do not exceed 7.5 grams.) currently controlled substance certification. While DEA is not making
• Nonliquid forms are packaged as registrants, chain stores that are not this fee effective with this Interim Rule,
required. registrants, and individual outlets. DEA is providing background
• Scheduled listed chemical products Chain stores wishing to file self- discussion and rationale for this
are stored behind the counter or in a certifications for more than 10 locations decision here so that all persons will be
locked cabinet. will have to print or copy the form aware of this issue.
• A written or electronic logbook electronically and submit the Section 886a of the CSA defines the
containing the required information on information to DEA by mail. DEA will Diversion Control Program as ‘‘the
sales of these products is properly work with these persons to facilitate this controlled substance and chemical
maintained. process. Persons interested in this self- diversion control activities of the Drug
• The logbook information will be certification option should contact DEA Enforcement Administration,’’ which
disclosed only to Federal, State, or local for assistance. For current DEA are further defined as the ‘‘activities
law enforcement and only to ensure registrants, the system will pre-populate related to the registration and control of
compliance with Title 21 of the United the form with basic information. the manufacture, distribution and
States Code or to facilitate a product Because CMEA specifically states that dispensing, importation and exportation
recall. a separate self-certification is required of controlled substances and listed
The seller must train its employees and for each separate location at which chemicals.’’ The CSA also states that
self-certify before either the seller or scheduled listed chemical products are reimbursements from the Diversion
individual employees may sell sold, mobile retail vendors must self- Control Fee Account ‘‘* * * shall be
scheduled listed chemical products. The certify for each location at which sales made without distinguishing between
self-certification is subject to the transactions occur. This self- expenses related to controlled
provisions of 18 U.S.C. 1001. A certification for locations is required substances activities and expenses
regulated seller who knowingly or even if the same person or persons sell related to chemical activities.’’ [Pub. L.
willfully self-certifies to facts that are at each of the different locations. 108–447 Consolidated Appropriations
not true is subject to fines and DEA requests comments on who Act of 2005].
imprisonment. should be authorized to sign the self- In addition, Section 111(b)(3) of the
certification for the regulated seller. The Departments of Commerce, Justice, and
Training. DEA has developed training person should be in a position to know State, the Judiciary, and Related
that it has made available on its Web that all employees who require training Agencies Appropriations Act of 1993
site (http:// have been trained and that the retail (Pub. L. 102–395), codified at 21 U.S.C.
www.deadiversion.usdoj.gov). outlet is complying with all other 886a(3), requires that ‘‘fees charged by
Employers must use the content of this requirements and should be authorized the Drug Enforcement Administration
training in the training of their to sign documents for the regulated under its diversion control program
employees who sell scheduled listed seller. shall be set at a level that ensures the
chemical products. An employer may Time for self-certification. CMEA recovery of the full costs of operating
include additional content to DEA’s, but requires that regulated sellers self- the various aspects of that program.’’
DEA’s content must be included in the certify by September 30, 2006. Although CMEA implements new requirements
training. For example, a regulated seller CMEA appears to link self-certification governing the sale of scheduled listed
may elect to incorporate DEA’s content to training of each individual who will chemical products, defined as
into initial training for new employees. deliver the products to customers, the nonprescription drug products
Training records. On and after high rate of employee turnover in the containing ephedrine, pseudoephedrine,
September 30, 2006, each employee of retail sector could require frequent or phenylpropanolamine. CMEA
a regulated seller who is responsible for submissions of self-certifications if the requires self-certification for all
delivering scheduled listed chemical regulated seller needed to recertify each regulated sellers of scheduled listed
products to purchasers or who deals time a new employee is trained. DEA, chemical products. CMEA also exempts
directly with purchasers by obtaining therefore, will require regulated sellers retail distributors from registration
payment for the scheduled listed to self-certify by September 30, 2006. requirements under the CSA; however,
chemical products must undergo When regulated sellers file the initial in practice, retail distributors have not
training and must sign an self-certification, DEA will assign them previously registered with DEA because
acknowledgement of training received to groups. Each group will have an they limited their sales to below
prior to selling scheduled listed expiration date that will be the last day threshold quantities and to products
chemical products. This record must be of a month from 12 to 23 months after sold in blister packs.
kept in the employee’s personnel file. the initial filing. After the second self- DEA considers the self-certification
Self-certification. On and after certification, regulated sellers will be requirements of the CMEA to fall within
September 30, 2006, the regulated seller required to self-certify annually. It is the the legal definition of control as
must self-certify to DEA as described responsibility of the regulated seller to governed by Section 886a of the CSA
above. DEA has established a Web page ensure that all employees have been (see above). Accordingly, these activities
that will allow regulated sellers to trained prior to self-certifying each time. fall under the general operation of the
complete the self-certification on-line It is also the responsibility of the Diversion Control Program and are
and submit it to DEA electronically. A regulated seller to ensure that they self- subject to the requirements of the
self-certification certificate will be certify before the self-certification Appropriations Act of 1993 that
generated by DEA upon receipt of the lapses. DEA requests comments on mandates that fees charged shall be set
application. The regulated seller will annual self-certifications versus at a level that ensures the recovery of
print this self-certification certificate, or certifications whenever new employees the full costs of operating the various
if the regulated seller is unable to print are trained or quarterly self-certification. aspects of the Diversion Control
it, DEA will print and mail the Fee for self-certification. In a separate Program. The self-certification
certificate to the self-certifier. The Notice of Proposed Rulemaking, DEA is requirements of CMEA fall under these
‘‘various aspects.’’ Therefore, in its creation of history, renewal cycles, Web hosting, monitoring and
Notice of Proposed Rulemaking, DEA investigative tools, business validation maintenance costs (including hardware
will propose to charge a fee for each rules, and development and and software maintenance), and annual
self-certification to comply with these maintenance of the self-certification inflation adjustments. Therefore, DEA
statutory requirements. Web site. will propose in its separate Notice of
DEA is proposing, in its separate In its Notice of Proposed Rulemaking, Proposed Rulemaking, that the 89,000
Notice of Proposed Rulemaking, that the DEA is proposing that when regulated persons DEA estimates will self-certify
fee for self-certification will cover all sellers submit a self-certification online with the Administration would pay a
associated costs, including the initial via the DEA self-certification Web site
self-certification fee of $32 for the Fiscal
one-time costs of setting up the self- that they pay a fee by credit card at the
Year 2006 through Fiscal Year 2008
certification program, Web site, and time of self-certification. DEA calculated
programmatic infrastructure, as well as this fee based on estimated set-up costs period.
ongoing costs associated with the in Fiscal Year 2006 ($117,198) and To calculate the fee, DEA divided the
provision of self-certifications, call Fiscal Year 2007 operating costs total costs for Fiscal Years 2006 through
center support, maintenance of the self- ($1,624,443) totaling $1,741,641, as 2008 by the anticipated population of
certification system, printing costs for shown below in Table 3. The initial affected regulated sellers of 89,000. DEA
certificates that regulated sellers cannot systems development and set-up costs estimates 89,000 current retail vendors
print, financial management, and other will not be repeated in subsequent of scheduled listed chemical products.
related costs. DEA must establish a years. The operational and maintenance All costs are shown in the table below
program to train its employees to costs for Fiscal Year 2008 are estimated for Fiscal Years 2006 through 2008. The
provide information regarding, and to be $1,099,782. Total annual costs self-certification costs reflect the cost
accept, self-certifications and must associated with operating the self- per each self-certification per each
establish the infrastructure necessary for certification process include staff costs, facility as required by CMEA.
the program. Required systems include operational and administrative costs,
TABLE 3.—SELF-CERTIFICATION COSTS AND FEE CALCULATION

Project detail 2006 * 2007 2008 Total cost
Planning 1 ................................................................................................................. $3,029 $36,343 $37,002 $76,373

Design, Development, Deployment 2 ....................................................................... 43,512 703,863 71,662 819,037
Call center, Finance, Mail room, Printing 3 .............................................................. 59,253 711,034 723,916 1,494,203
Maintenance 4 .......................................................................................................... 11,405 173,203 176,341 360,949
Enhancements 5 ....................................................................................................... ...................... 90,861 90,861
Total .................................................................................................................. 117,198 1,624,443 1,099,782 2,841,423
Population ................................................................................................................ ...................... 89,000 89,000 ......................

Cost per certification ................................................................................................ ...................... ...................... ...................... 31.92
1 Planning is the costs to the government to plan the development, design, and implementation of the self-certification online system. This item
is the costs of three percent of the time used by five government employees to supervise and manage software development.
2 Design, development and deployment of the online self-certification system represents the cost to pay contract programmers, web designers,
system administrators and database administrators to design, develop, and deploy the new application. These costs include testing and quality
assurance of the new software and establishment of new security controls. The self-certification system will be designed with business validation
rules and provide investigative tools to ensure compliance with the new legislation.
3 Call Center, finance, mail room and printing represent the following costs.
• DEA currently operates a registration Call Center. Based on current Call Center customer service representative costs, this item includes the
cost of the additional time required to respond to inquiries regarding the CMEA self-certification program. DEA provides call center assistance to
approximately 400,000 persons annually. DEA estimates that CMEA will increase that population by 89,000 persons, a 23% increase.
• DEA currently operates a registration Finance Center. Based on current Finance Center employee costs, this item includes the cost of the
additional time required to process fees collected from CMEA self-certifications.
• DEA currently operates a registration Mail Room. Based on current Mail Room clerical costs, this item includes cost of employee time for
handling and mailing out of CMEA self-certification certificates if the self-certifier is unable to print the certificate.
• DEA currently operates a Printing and Mailing Facility. Based on current Printing Costs, this item includes paper, toner, envelope, and post-
age costs to mail out the CMEA self-certification certificates.
4 Maintenance. This item includes all employee salaries, hardware maintenance, and software license costs associated with the daily operation
of the self-certification system.
5 Enhancements. This item is the enhancement of the system to add the ability to maintain a history of changes to records and to allow for
yearly renewal of records.
* 2006 is for 1 month of operations.
To minimize administrative and sellers be significantly more or less than existing registrants are required by the
collection burdens, it is DEA’s policy to 89,000, DEA may adjust the self- CMEA to self-certify with DEA if selling
round to the nearest dollar when certification fee as appropriate through scheduled listed chemical products, in
calculating fees. The annual self- future rulemakings. In any case, DEA its Notice of Proposed Rulemaking, DEA
certification fee will be clearly defined will not exceed its operating budget as is proposing that the self-certification
on the self-certification Web site. authorized by Congress. fee be waived upon submission of an
However, in setting this fee DEA notes In implementing this fee, DEA also active DEA registration number.
that it is based on assumptions about notes that many of the affected regulated Other DEA activities associated with
sellers are already registered with DEA self-certification and compliance with
the total number of regulated sellers
to dispense controlled substances and CMEA include enforcement and judicial
who will be required to self-certify.
therefore already pay a registration/ proceedings. CMEA gives DEA the
Should the total number of regulated reregistration fee to DEA. While these authority to prohibit a regulated seller
from selling scheduled listed chemical technicians where CMEA does not), the for issuing and responding to an order
products for certain violations of CMEA. State requirements continue to be in to show cause why the regulated seller
If DEA issues an order to a regulated force. If there are State requirements or distributor should not be prohibited
seller prohibiting that regulated seller that are less stringent than the CMEA from selling scheduled listed chemical
from selling scheduled listed chemical provisions (e.g., higher daily limits, products.
products, the regulated seller is entitled exemptions of some products), CMEA Sections 1314.01 and 1314.02 simply
to an administrative hearing if the seller supersedes the provisions. DEA state the scope and applicability of the
files a timely request for a hearing. The emphasizes that if State requirements part. Section 1314.03 defines ‘‘mail
costs of these enforcement activities and for records cover the information CMEA order sales’’ using the language from
the subsequent proceedings must be mandates, the record created to meet the § 1310.03(c) and further clarifies that
supported through fees pursuant to the State law is sufficient to meet DEA’s mail order includes any retail sale for
above described statutory requirements. regulation. personal use where the product is
DEA notes that these costs are not Regarding quantity sold, units may be shipped by U.S. mail or by private or
recovered in these fee calculations as specified in terms of the weight of the common carriers whether the order is
DEA is uncertain of their utilization. product or in terms of the number of received by mail, phone, fax, the
However, once DEA is able to determine packages sold. Logbook systems that Internet, or any method other than a
the frequency of use of these tools, and display the quantity of the product sold face-to-face transaction.
their associated costs, these costs will be by UPC code are sufficient to meet Section 1314.05 incorporates the
recovered through fees associated with DEA’s requirements. These options do statutory requirement for blister packs
self-certification as established in future not exclude other methods of displaying for nonliquids unless such packaging is
rulemakings. the quantity sold. not technically feasible.
DEA is accepting public comment on Section 1314.10 states the regulations
Relationship to State Laws the interaction between state and federal do not preempt State laws unless there
Many States have enacted laws and/ logbook requirements. In addition, DEA is a positive conflict between the laws
or regulations that impose conditions on is accepting public comment on the and the regulations such that the two
the sale of scheduled listed chemical broader interplay and potential overlap cannot consistently stand together. This
products. between state regulations and CMEA language is drawn from 21 U.S.C. 903.
• Eight states have enacted and six requirements, and whether compliance Section 1314.15 copies the
others have proposed legislation that with state regulations, if comparable to requirements for reporting losses,
makes these products Schedule V or more stringent than an associated including thefts, that currently exist in
controlled substances. Among other CMEA requirement, should constitute § 1310.06. DEA emphasizes that thefts
requirements, Schedule V substances compliance with such Federal must be reported as well as unusual or
may be sold only by a pharmacist to requirement. excessive losses or disappearances.
individuals who are at least 18. A In subpart B, § 1314.20 includes the
Discussion of the Rule statutory requirements limiting sales,
logbook of the sales must be maintained.
• Sixteen states have passed laws To make the rule easier to follow for the daily limit of 3.6 grams and the 30-
limiting sales to a pharmacist or regulated sellers and mail order/Internet day mobile retail vendor limit of 7.5
pharmacy technicians or requiring that sellers, DEA is creating a new part 1314 grams. The 30-day limit of 9 grams
the products be stored behind the that will include all requirements applies to purchasers who are not
counter. related to the sale of scheduled listed addressed by this regulation. As noted
• Twenty-seven states require a photo chemical products to end users. previously, this provision is not
ID for such purchases. Regulations for the retail sale of these included in this rule, but will be
• Twenty-six states require a signed products that currently exist in part addressed in other rulemakings DEA is
logbook. 1310 will either be moved, if still promulgating to implement the various
• Twenty-seven states impose single applicable, or removed. The new provisions of the Combat
transaction limits. statutory definitions of ‘‘scheduled Methamphetamine Epidemic Act of
• Nineteen states have monthly or listed chemical product,’’ ‘‘regulated 2005.
weekly limits. seller,’’ ‘‘mobile retail vendor,’’ and ‘‘at Section 1314.25 incorporates CMEA’s
• Twenty-seven states have retail’’ are being added to part 1300 provisions for storing the products
exemptions for prescription drugs and (Definitions). The definition of ‘‘retail behind the counter or in a locked
various forms of over-the-counter (OTC) distributor’’ is also being revised. Most cabinet. Mobile retail vendors are
drugs (liquids, pediatric forms, etc.). of the new provisions in this Interim required to store the product in a locked
• One state requires a prescription to Final Rule are drawn from section 711 cabinet.
purchase these products. of the USA PATRIOT Improvement and Section 1314.30 covers recordkeeping
As the list indicates, the State laws Reauthorization Act of 2005. (logbook) requirements from CMEA as
vary considerably. Some parts of a State Part 1314 is divided into four well as requirements currently in
law may be less stringent than the subparts. Subpart A contains § 1310.04. In addition to CMEA’s
CMEA requirements; other parts may be requirements that apply to any retail requirements, DEA has copied the
more stringent. CMEA does not preempt sale. Subpart B applies to sales by existing requirements from part 1310
those requirements under State laws/ regulated sellers (i.e., sales for personal relative to where the records must be
regulations that are more stringent than use, both in number of sales and volume kept (at the place of business or at a
the CMEA requirements. Simply put, all of sales, either directly to walk-in central location if DEA has been
persons subject to CMEA must comply customers or in face-to-face notified). DEA is including in this
with the CMEA and the laws in the transactions, by stores or mobile retail section language stating that if a
State(s) in which they sell scheduled vendors). Subpart C applies to retail regulated seller is already maintaining
listed chemical products at retail. Where sales that are shipped by mail or records of these sales under State law,
the CMEA is less stringent than a State common or private carriers, regardless those records may be used to meet this
law (e.g., the State limits sales to of how those sales are ordered. Subpart requirement if they include the
licensed pharmacists or pharmacy D contains the procedural requirements information specified in CMEA.
The part 1310 requirements Section 1314.45 incorporates the transaction’’ is revised as mandated by
incorporated into the amended privacy protection provisions of CMEA. section 712 of CMEA.
regulations do not include the provision These provisions define who may access In § 1309.71, paragraph (a)(2), which
that a regulated seller with multiple the sales records and the use to which requires certain ephedrine products to
locations must have a system to detect the data may be put. They also provide be stored behind the counter, is being
a person purchasing from multiple a good faith protection to regulated removed because the new CMEA
locations owned or operated by the sellers that release the data to law requirements supersede it. CMEA
regulated seller. CMEA in section 711(f) enforcement authorities. imposes the same restrictions on all
provides for a civil penalty for a person Section 1314.50 includes CMEA’s scheduled listed chemical products
who sells at retail a scheduled listed provision that states that a seller may unless they are stored in a locked
chemical product in violation of the take reasonable measures to guard cabinet in areas where the public has
daily 3.6 gram sales limit, ‘‘knowing at against employing people who may access.
the time of the transaction involved present a risk of diversion. The In § 1310.04, paragraph (f)(1)(ii) is
(independent of consulting the logbook measures may include asking about revised to indicate that the thresholds
* * *) that the transaction is a convictions of any crimes involving presented in the previous paragraph and
violation.’’ While the availability of civil controlled substances or scheduled in paragraph (g) for ephedrine,
penalties is not necessarily co-extensive listed chemical products. pseudoephedrine, and
with the chemical control requirements In subpart C, § 1314.100 incorporates phenylpropanolamine apply only to
of the new law, DEA is not mandating, the daily and 30-day sales limits for non-retail distribution, import, and
by this rule, that regulated sellers, other mail order sales. Section 1314.105 export and references part 1314 for
than mail order and mobile retail provides the above described retail sales. The table of thresholds for
vendors, track multiple sales to requirements for verifying identity of retail distribution has been removed.
individuals on a single day within the the purchaser prior to shipment of the In § 1310.05, paragraph (f)(2) is
same retail outlet or across outlets of the product. Section 1314.110 covers revised to remove retail sales of
same company. CMEA explicitly reports on mail order sales and is copied scheduled listed chemical products.
requires mail order outlets and mobile from § 1310.06. Finally, § 1314.115 Sections 1310.14 and 1310.15 are
retail vendors to limit sales to an copies language from § 1310.05(f) on being removed because the CSA no
individual to 7.5 grams in a 30-day distributions not subject to reporting longer treats certain ephedrine products
period; it imposes no similar (sample packages, sales to long-term differently from other scheduled listed
requirement on other retail sellers to care facilities, prescription drugs). chemical products. These sections are
limit 30-day sales to individuals. The CMEA added to 21 U.S.C. 842 a being replaced by new § 1310.16, which
30-day limit of 9 grams is imposed on provision that authorizes DEA to states that a manufacturer may apply to
the purchaser, not the seller. prohibit a regulated seller or a mail have a scheduled listed chemical
Section 1314.35 incorporates the order seller from selling scheduled product exempted from the
statutory requirements for training of listed chemical products if the seller is requirements if DEA determines that the
sales personnel. DEA has developed found to be knowingly or recklessly in product cannot be used in the illicit
training material, which it has made violation of the provisions controlling manufacture of methamphetamine. DEA
available on its Web site (http:// retail sales. To take this step, DEA must is adopting the application process that
www.deadiversion.usdoj.gov). issue an order to show cause, as it does currently applies to ephedrine products
Section 1314.40 covers CMEA’s to suspend or revoke registrations. DEA that include other medically significant
requirements on self-certification. As is including in subpart D in §§ 1314.150 ingredients (§ 1310.14).
discussed above, DEA is setting an and 1314.155 provisions on the process Regulatory Certifications
annual period for renewal of the of issuing and responding to an order to
certification. show cause. These sections are taken Administrative Procedure Act (5 U.S.C.
DEA has developed a web site that from part 1309 and are the same as DEA 553)
will allow many regulated sellers to uses to issue and reach a conclusion on The Administrative Procedure Act
complete and submit the self- orders to show cause under other DEA (APA) generally requires that agencies,
certification form on line and print out programs. If DEA issues an order to prior to issuing a new rule, publish a
a self-certification certificate for their show cause, the regulated seller or mail Notice of Proposed Rulemaking in the
records. The information required will order distributor must respond to the Federal Register. The APA also
include the name and address of the order to show cause within 30 days of provides, however, that agencies may be
location and a point of contact. The service of the order to show cause. The excepted from this requirement when
regulated sellers will be classified into regulated seller or mail order seller may ‘‘the agency for good cause finds (and
three categories: Chain stores that are request a hearing. The seller may incorporates the finding and a brief
currently controlled substance continue to sell scheduled listed statement of reasons therefore in the
registrants, chain stores that are not chemical products until DEA issues a rules issued) that notice and public
registrants, and individual outlets. final order. If DEA finds that a regulated procedure thereon are impracticable,
Chain stores wishing to file self- seller or mail order distributor poses an unnecessary, or contrary to the public
certifications for more than 10 locations imminent danger to public health or interest.’’ 5 U.S.C. 553(b)(B).
will have to print or copy the form safety, DEA may suspend the seller’s With publication of this interim rule,
electronically and submit the right to sell scheduled listed chemical DEA is invoking this ‘‘good cause’’
information to DEA by mail. DEA will products pending a final decision on the exception to the APA’s notice
work with these persons to facilitate this order to show cause. requirement based on the combination
process. Persons interested in this self- of several extraordinary factors. CMEA

Other Changes
certification option should contact DEA requires that on and after September 30,
for assistance. For current DEA As noted above, CMEA’s new 2006, regulated sellers selling scheduled
registrants, the system will pre-populate definitions will be added to § 1300.02. listed chemical products at retail shall
the form with basic information. In addition, the definition of ‘‘regulated self-certify with DEA in order to
continue to sell these products. CMEA dispense with the 30-day delayed small entities, using a pre-statutory
imposes sales limits, purchase limits, effective date requirement ‘‘for good baseline of comparison (i.e., the state of
product placement requirements, mail cause found and published with the the market prior to the Combat
order customer identification rule.’’ Since it would be unnecessary to Methamphetamine Epidemic Act of
requirements, and other requirements, provide a delayed effective date for a 2005).
some of which must be specified by change to the law that has already taken Although not directly the subject of
regulation, all with an effective date of effect DEA has dispensed with the 30- this rule, manufacturers and distributors
September 30, 2006. Based on the day delayed effective date requirement. will be affected by a reduction in sales
effective date of this law, it is The sales limits and blister pack of these products. The manufacturers of
impracticable for DEA to comply with provisions became effective on April 8, scheduled listed chemical products are
the APA’s notice and comment 2006. The requirements for logbooks, also the manufacturers of the substitutes
requirements due to the limited time training, and self-certification become being marketed and the distributors
involved. Were DEA not to publish this effective September 30, 2006. handle both product lines; DEA has not
Interim Rule with Request for Comment, been able to identify any manufacturer
Regulatory Flexibility Act
regulated sellers selling scheduled listed of these products that does not also
chemical products at retail would not be The Deputy Administrator hereby market substitute products. DEA expects
able to self-certify by the date specified certifies that this rulemaking has been that the primary impact will be limited
in the law. Were this not to occur, these drafted in accordance with the to reduction in sales that occurs because
regulated sellers would be forced to stop Regulatory Flexibility Act (5 U.S.C. diversion is curbed. If the sales
selling scheduled listed chemical 605(b)). The Regulatory Flexibility Act restrictions and quotas reduce the
products, or violate the law by doing so. (RFA) applies to rules that are subject to United States’ demand for these
Mail order distributors would also have notice and comment. Because this rule chemical products, the world
difficulty, as DEA is required by is simply codifying statutory provisions, production of the chemicals is likely to
regulation to establish procedures for DEA has determined, as explained drop, which will make less available to
these persons to identify their customers above, that public notice and comment be diverted to superlabs operated by
prior to shipping product. Without these are not necessary. Consequently, the drug cartels. DEA seeks comments on
regulations, mail order distributors RFA does not apply. Where DEA has impacts on manufacturers and
would not be able to sell scheduled discretion in the way in which distributors.
listed chemical products. Therefore, provisions of CMEA are implemented,
DEA also finds that it is contrary to the however, DEA is seeking public Executive Order 12866
public interest not to issue these comment and has sought, through the The Deputy Administrator further
regulations as an Interim Rule, thereby development of training materials and certifies that this rulemaking has been
allowing regulated sellers and mail Web sites for self-certification, to reduce drafted in accordance with the
order distributors to fully comply with the cost to small entities. principles in Executive Order 12866
the requirements of CMEA. While the Although the RFA does not apply to § 1(b). It has been determined that this
CMEA was signed into law in March of this final rule, DEA has reviewed the is ‘‘a significant regulatory action.’’
2006, most of the law must be in effect potential impacts. The rule will affect a Therefore, this action has been reviewed
by September 30, 2006. The broad scope substantial number of small entities, but by the Office of Management and
of the new law, as well as the expedited DEA does not believe that it will have Budget. As discussed above, this action
effective dates, is a clear reflection of a significant economic impact on small is codifying statutory provisions and
Congress’s concern about the nation’s entities. As shown in the next section, involves no agency discretion. However,
growing methamphetamine epidemic OTC medications as a whole represent DEA has reviewed the potential benefits
and its desire to act quickly to prevent less than two percent of sales except for and costs following OMB Circular A–4.
further illicit use of these chemicals. drug stores and mail order houses. Even The CMEA requirements impose the
In light of these factors, DEA finds the highest estimate of the value of following costs on regulated sellers:
that ‘‘good cause’’ exists to issue this scheduled listed chemical products • Training of employees who sell
interim rule without engaging in represents less than 10 percent of the scheduled listed chemical product sales
traditional notice and comment OTC market. Consequently, the loss of (0.5 hours).
rulemaking. In so doing, DEA recognizes sales, if that occurs, will reduce sales at • Time to file the self-certification
that exceptions to the APA’s notice and most by a fraction of one percent, not a (0.5 hours).
comment procedures are to be significant economic impact. DEA • Costs for logbooks ($47.55) or
‘‘narrowly construed and only expects that regulated sellers will creating an electronic record system.
reluctantly countenanced.’’ Am. Fed’n decide whether their sale of the • Additional time per sale to verify
of Gov’t Employees v. Block, 655 F2d products is great enough to justify the purchaser IDs and enter information
1153, 1156 (D.C.Cir. 1981) (quoting New cost of compliance or whether they can into the logbook (1 to 2 minutes).
Jersey Dep’t of Envtl. Prot. v. EPA, 626 retain sufficient sales revenues by • Storage space behind the counter or
F.2d 1038, 1045 (D.C.Cir. 1980)). Based shifting to non-regulated substitutes. in locked cabinets ($200-$600).
on the totality of the circumstances The smallest stores, which DEA expects DEA is seeking comments regarding
associated with the CMEA, however, to be convenience stores, may limit their all of the above assumptions and
DEA finds that invocation of the ‘‘good sales of the products to individual estimates.
cause’’ exception is justified. transactions involving packages The requirements may also affect the
As noted throughout this document, containing not more than 60 milligrams sales at regulated sellers. If a seller
DEA is seeking comments on details of of pseudoephedrine, which would allow decides to avoid the requirements by
implementation, particularly related to them to avoid the recordkeeping eliminating the product line or selling
self-certification, where it has requirements. In this case, their total only the available substitutes, some
discretion. cost of compliance could be about $50 customers may seek the products from
Under section 553(d) of the APA, DEA for training and self-certification. DEA is sellers that continue to carry them.
must generally provide a 30-day delayed specifically seeking public comments Regulated sellers, manufacturers, and
effective date for final rules. DEA may regarding the cost of this regulation to distributors will also see some reduction
in sales as a result of diversion from purchase substitutes available on open as scheduled listed chemical products,
regulated sellers becoming more shelves. either because the consumers are
difficult. • The number of stores that will elect unaware of the product change, because
Although DEA has estimated the unit to use bound logbooks versus using the substitutes meet the consumers’
cost of training, certification, logbooks, electronic systems. needs, or because they are unwilling to
logbook entries, and storage space, DEA • The number of existing electronic spend extra time to buy scheduled listed
cannot estimate the total cost of the rule signature capture systems that are chemical products.
because the following critical items are capable of accepting or linking to name Regulated Sellers. The 2002 Economic
unknown: and address records.
• The value of the existing market in Census data on product line sales
• The percentage of existing sales indicate that about 92,000 retailers sell
these products and the number of (and theft of the product) that is being
transactions that this market represents. OTC medications. These include
diverted to illicit use. pharmacies, grocery stores, discount
• The number of stores that currently
sell these products. DEA is seeking comments and data from stores, warehouse clubs and superstores,
• The number and type of stores that the industry that would help address convenience stores, variety stores, and
will continue to sell the products, the these items and provide an estimate of mail order stores. In addition, up to
number that will elect to sell only the the impact. DEA recognizes that the 40,000 gas stations with convenience
substitutes, and the number that will answers to some of these issues will stores may sell OTC drug products. The
limit sales of the products to individual evolve over time as regulated sellers and number of retailers in each sector, the
transactions involving not more than manufacturers adjust to consumer number with pharmacies, the number
one 60-milligram or two 30-milligram choices. For example, regulated sellers that sell nonprescription OTC drugs,
pseudoephedrine dosage units, which may see little impact beyond the initial and the percentage of their sales
would not require recordkeeping, the costs of training and self-certification if represented by OTC drugs are shown in
most expensive part of compliance. most consumers elect to purchase the Table 4 below. DEA solicits comments
• The number of customers who will substitute products that are already on the number of these entities that sell
seek out these products rather than available under the same brand names these products.
TABLE 4.—SECTORS SELLING SCHEDULED LISTED CHEMICAL PRODUCTS

Percent OTC as
Total Number w
NAICS Number w OTC without percent of
number pharmacy pharmacy total sales *
44511 Grocery stores ...................................................................... 66,150 19,721 26,029 70.2 1.30

44611 Pharmacy and drug stores ................................................... 40,234 39,121 36,493 2.8 5.70
452112 Discount department stores ................................................ 5,650 4,887 2,079 13.5 1.80
45291 Warehouse clubs and superstores ....................................... 2,912 2,553 2,758 12.3 1.20
Subtotal ..................................................................................... 114,946 66,282 67,359
44512 Convenience stores .............................................................. 29,212 370 12,399 98.7 1.60

44711 Gas stations with convenience stores .................................. 93,691 0 ** 40,068 100 ** 1.10
45299 All other general merchandise stores *** .............................. 28,456 577 11,840 98 1.20
4541 Electronic shopping and mail order houses ........................... 15,910 453 250 97.2 13
Total .......................................................................................... 167,269 1,400 24,489–64,557

* For those firms that handle the product line.
** Drugs, health aids, beauty aids including cosmetics.
*** Includes variety stores.
Even if all gas stations with is between 89,000 and 118,000.1 This the number, size, and sales of mail order
convenience stores sold OTC drugs, estimate does not specifically include entities.
there would be fewer of these mobile retail vendors, but DEA does not Substitutes. As discussed above,
establishments than exist in the main believe that they constitute a large many States have imposed sales
sectors selling OTC drugs. Most gas segment of retail sellers. The actual restrictions on scheduled listed
stations and convenience stores do not number could be lower; many of the chemical products prior to CMEA. In
have pharmacies; OTC products stores, particularly convenience stores, reaction to those restrictions and to
represent a very small percentage of do not carry a full range of OTC drug concern about diversion of their
sales for them. products, and some may not sell this products, manufacturers have
DEA cannot determine what category of drugs. DEA seeks comment reformulated many product lines to
percentage of those selling OTC drugs on this issue. Conversely, large mail alternative decongestants that cannot be
order distributors may handle large used to make methamphetamine. These
sell scheduled listed chemical products,
quantities of scheduled listed chemical substitutes are being sold under the
although it is likely that outlets that
products. DEA also seeks comment on same product names and in boxes that
have pharmacies sell these products.
look the same as those used for
Because 16 States representing 27 scheduled listed chemical products.

percent of the U.S. population already One major manufacturer expected to
1 The 27 percent is a conservation estimate; the
limit sales of these products to have converted half of its decongestant
16 states represents 28 percent of the convenience
pharmacies, DEA estimates that the stores in the country and 35 percent of the gas product line to substitutes by January
number of potentially regulated entities stations with convenience stores. 2006. Two of the largest drug store
chains do not list scheduled listed requirements on pharmacy wait times prices that are equivalent to those for
chemical products on their online and any staffing costs these scheduled listed chemical products
stores, but offer more than 60 cold requirements generate. Alternatively, if (based on maximum daily dosage units).
medications containing other few consumers seek the products, many The additional costs of handling
ingredients. retailers may decide not to carry them. scheduled listed chemical products
At present, there is little information This decision would eliminate their could, however, increase their prices if
on how consumers will react to sales costs, but could impose a cost on the sellers pass on the costs to consumers.
restrictions. On April 7, 2004, consumer who has to go to multiple Diversion. The limits and restrictions
Oklahoma made pseudoephedrine stores or travel greater distances to find that CMEA imposes are intended to
products Schedule V controlled the product. Regulated sellers who reduce the diversion of scheduled listed
substances, but exempted gel caps and continue to sell the products will have chemical products. Manufacturers and
liquids. According to IRI InfoScan, in to decide how to log the sales, which regulated sellers will see some
the 52 weeks after implementation, sales will impose costs. DEA is seeking reduction in sales as a result of retail
of all pseudoephedrine products fell comment on the cost of logging sales, purchases for diversion declining. DEA
16.2 percent and sales of the substitutes whether this log be paper or electronic. has no reliable information on the
rose by 24 percent. Sales of exempted Part of each seller’s calculation will be percentage of the market in these
gel caps rose 109.3 percent and liquids whether the value of the sales is products that was diverted. DEA expects
14.5 percent, but tablets fell 35.5 sufficient to offset the costs. As that as it implements other CMEA
percent. Overall, sales in the cold and discussed above, OTC medications as a requirements it will have a better
allergy group in Oklahoma fell 3.9 whole represent between one and two understanding of the size of the
percent. Illinois, which imposed less percent of the sales of sellers except for diversion market. Nonetheless, because
stringent rules, saw little change in pharmacies and mail order sellers; sales of these products represent less
purchases, according to IRI InfoScan. scheduled listed chemical products than one percent of most retailer’s total
The Slone Epidemiology Center at probably represent less than 10 percent sales, the loss of sales for diversion is
Boston University took a broader look at of those sales. For many smaller stores unlikely to impose a substantial cost on
drug purchases in 2004 and found that a small decline in sales, if that occurs, retailers selling to legitimate purchasers.
between 2003 and 2004, the number of may be less costly than compliance. Implementation Costs. For most
adults reporting use of pseudoephedrine DEA has estimated that small regulated sellers that continue to carry
fell from 7 percent to 4.8 percent. This convenience stores sell between $20 and scheduled listed chemical products, the
decline occurred prior to State $40 a month of these products for largest cost will be the added time to
restrictions and to the availability of legitimate purposes (69 FR 8691, collect and record logbook information
many substitute products, but after February 25, 2004). regarding the purchaser at each
limits on purchases were set by Federal Size of the market; data issues. DEA
transaction. DEA estimates that it will
law and by many large chain stores. has been unable to determine the size of
If national patterns reflect Oklahoma’s take one to two minutes for the seller
the market for scheduled listed
experience, a 3.9 percent drop in cold/ and purchaser to enter into the logbook
chemical products. The Food and Drug
allergy medicine sales would imply a the information required by CMEA—
Administration reported that IMS
$117,000,000 loss in sales. However, if name and address of purchaser, name
Health data estimated the market is
they reflect national trends reported by and quantity of product sold, date and
about $500 million; FDA further
the Slone Epidemiology Center, a 2.2 reported that IRI estimated the market time of transaction, and purchaser’s
percent drop in cold/allergy medicine was $1.5 billion. The IRI Oklahoma data signature—and seeks comment on this
sales would imply a $33,000,000 loss in implied that pseudoephedrine estimate.
sales. Since market effects will occur represented about 75 percent of the cold Assuming market changes may reflect
within the context of increased medication market, but the value other the Oklahoma experience to a degree, a
marketing and distribution of sources provide for the cold medication 16 percent drop in sales of regulated
substitutes, the direct effects on market in 2005 is about $4 billion. products would change the number of
revenues could be lower than either IRI indicated that national sales for transactions that would require
estimate. the category had dropped by 0.5 percent recordkeeping to 56,490,000. Assuming
It is not clear how consumers and between May 2004 and May 2005. A the recordkeeping requirements add 2
retailers will react to a nationwide limit Kline & Company study indicated that minutes to each transaction, they would
on all scheduled listed chemical sales in the cold medication category impose an annual cost between
product sales because the availability of rose 12 percent in 2005. Part of the $73,000,000 and $80,000,000 in terms of
substitute products may increase. If problem is that different groups appear time burden. These estimates assume,
consumers continue to ask for to define the market segment differently, for the low end, the average hourly wage
scheduled listed chemical products, including a different mix of products. of retail sales clerks ($11.86 with fringe
retailers will incur costs to store them DEA seeks information on the actual benefits) plus public time ($27/hour);
behind the counter or in locked cabinets value of the market for scheduled listed for the high end, it assumes the average
and to record every transaction. The chemical products and the number of hourly wage of a pharmacy technician
purchaser will take extra time and transactions. Even with the total value ($15.26 with fringe benefits) plus public
possibly delay other customers who of the market, DEA would need to time ($27/hour).
have to wait while the transaction is understand the value of the average Assuming market changes reflect data
completed. DEA notes that in stores transactions. The products are available reported by The Slone Epidemiology
with pharmacies, the recordkeeping in a wide variety of strengths and Center, a 2.2 percent drop in sales of
requirements established by this rule number of dosage units; the sales limits regulated products would change the
may direct a higher proportion of allow purchases of multiple packages of number of transactions that would
transactions to the pharmacy versus the most products. DEA also seeks require recordkeeping by 2,193,000.
standard checkout line. DEA is seeking comments on the effect of the Using the same assumptions regarding
public comment on the effect of these restrictions on product prices. At increased transaction times, this would
recordkeeping and product placement present, the substitutes are selling for imply an annual cost in terms of time
burden between $85,000,000 and Methamphetamine remains the many areas, the total cost would have
$93,000,000. primary drug produced in illicit been $50 million. The DAWN mortality
Another cost will be the costs of laboratories within the United States. data for 33 metropolitan areas in 2003,
recordkeeping systems. CMEA allows Data from the El Paso Intelligence the most recent year available, report
either a logbook or an electronic record. Center’s (EPIC) Clandestine Laboratory amphetamine or methamphetamine was
DEA is seeking comments on whether Database indicates that more than involved in 524 deaths and was the only
regulated sellers will be able to use 17,170 methamphetamine laboratory drug present in 93 of those deaths. A
electronic signature capture systems to incidents in calendar year 2004 and University of Arkansas Study on the
collect names and addresses as well as 12,139 incidents in calendar year 2005 economic impact of methamphetamine
signatures, the cost of adapting systems (as reported to EPIC through June 29, use in Benton County, Arkansas,
to perform this function, and likelihood 2006). According to EPIC, from January estimated that the average
that sellers will do this versus using a 2000 through June 2006, there were methamphetamine user cost his or her
bound logbook. DEA is seeking 7,125 laboratories reportedly using
information from regulated sellers on employer $47,500 a year, with 50
ephedrine and 44,380 reportedly using percent of cost due to increased
whether they plan to limit sales to pseudoephedrine as precursor material
pharmacy or special counters or absenteeism and 32 percent due to lost
for methamphetamine production. productivity.
whether they will handle sales at Additionally EPIC reports the seizure of
regular checkout lines. Finally, DEA is 51 amphetamine laboratories (using The surge in methamphetamine abuse
seeking comments on how much phenylpropanolamine) during the same and the manufacture of the drug in
behind-the-counter space regulated period. The vast majority of these clandestine laboratories has caused
sellers will need to devote to these laboratories used pharmaceutical serious law enforcement and
products, the cost of doing so, and the products containing pseudoephedrine, environmental problems, particularly in
extent to which costs may be passed on ephedrine, and phenylpropanolamine as rural communities. Rural areas are
to the consumer. the source of precursor material. frequently the site of clandestine
Blister Packs. For reasons of product laboratories because the manufacturing
safety and the previous blister-pack According to the Substance Abuse
and Mental Health Services process produces distinctive odors and
exemption, almost all scheduled listed can be identified if there are close
chemical products are already sold in Administration (SAMHSA), Drug Abuse
Warning Network (DAWN), in 2004, the neighbors. Besides causing crime as
blister packs. DEA seeks comments on
latest year for which data are available, people steal ingredients to make
whether this requirement imposes a
burden on any manufacturers. amphetamine and methamphetamine methamphetamine and steal to support
Benefits. Congress passed CMEA to was mentioned in almost 103,000 their addiction, the clandestine
make it more difficult for individuals to emergency department (ED) visits; laboratories often leave serious
purchase scheduled listed chemical methamphetamine accounted for 73,400 pollution behind. A laboratory can
products and use them to make of these visits. These numbers represent produce 6 to 10 pounds of hazardous
methamphetamine. The retail a rapid increase in recent years. waste for every pound of
restrictions are part of a series of steps SAMHSA reported that drug abuse- methamphetamine produced. Table 5
that Congress adopted to address the related ED visits involving shows the hazardous waste cleanup
sources of methamphetamine abuse; amphetamine/methamphetamine rose costs incurred by States and DEA by
other steps include import and from 25,200 in 1995 to 38,960 in 2002 Fiscal Year (October 1 through
production quotas and tracking of and 42,500 in 2003. If the cost of the September 30) for several previous fiscal
international transactions. visit is $500, which is probably low in years.
TABLE 5.—STATE AND FEDERAL CLANDESTINE LABORATORY CLEANUP COSTS

State/local
Fiscal year DEA cost Total cost
meth cost
1998 ............................................................................................................................................. $4,030,000 $1,420,000 $5,450,000

1999 ............................................................................................................................................. 3,020,000 8,420,000 11,440,000
2000 ............................................................................................................................................. 4,120,000 11,800,000 15,920,000
2001 ............................................................................................................................................. 2,800,000 19,240,000 22,040,000
2002 ............................................................................................................................................. 2,190,000 21,490,000 23,680,000
2003 ............................................................................................................................................. 1,150,000 15,040,000 16,190,000
2004 ............................................................................................................................................. 810,000 17,680,000 18,490,000
2005 ............................................................................................................................................. 650,000 17,020,000 17,670,000
2006* ............................................................................................................................................ 470,000 12,180,000 12,650,000
* Data for fiscal year 2006 is through the third quarter (June 30, 2006).
The Federal and State cleanups are The effectiveness of the control of retail sales will continue the trend of
generally limited to removing chemicals retail sales can be seen in the decline in reducing the number of clandestine
that could be reused; they do not clandestine laboratory incidents in laboratories. This trend will reduce the
address water and soil pollution that States such as Oklahoma. In 2003, cost to State and local governments as
remain. Owners of the property are before Oklahoma implemented retail well as the hazard to law enforcement
responsible for completing the cleanup sales controls, there were 1,068 officers and others from exposure to the
of contaminated water and soil, but if clandestine laboratory incidents in the hazardous chemicals left behind.
the owner cannot pay the cost, local State. In 2005, the first full year of the Conclusion. Because of the many
governments bear the burden or the sales controls, there were only 217 unknowns, DEA is unable to determine
contamination remains. incidents. The CMEA provisions on with any certainty whether the CMEA
requirements will impose an annual • What is the cost to manufacturers, (3) Enhance the quality, utility, and
cost on the economy of $100 million or given expected demand reductions for clarity of the information to be
more, the standard for an economically regulated products? collected; and
significant rule under Executive Order • To what extent, and under what (4) Minimize the burden of the
12866. If the value of the existing circumstances, can substitutes for the collection of information on those who
market is on the low end of the range regulated products reduce the expected are to respond, including through the
($500 million), the additional costs, cost of this regulation? use of appropriate automated,
including transaction costs, would be • What are the results of any recent electronic, mechanical, or other
considerably lower than $100 million studies on the effective doses of technological collection techniques or
even if there is no reduction in sales. If substitute products and their safety at other forms of information technology,
the value of the market is $1.5 billion different levels? e.g., permitting electronic submission of
and there is no reduction in sales, the responses.
• To what extent are training and
cost could exceed $100 million. DEA recordkeeping costs fixed versus Overview of This Information Collection
considers it likely that product variable?
switching and reduced sales will result (1) Type of Information Collection:
in annual costs below $100 million, but Paperwork Reduction Act of 1995 New collection.
until the statutory requirements are (2) Title of the Form/Collection: Self-
CMEA mandates a number of new certification, Training and Logbooks for
implemented and both retailers and
information collections and Regulated Sellers of Scheduled Listed
consumers respond, DEA cannot
recordkeeping requirements. Regulated Chemical Products.
estimate total costs with any certainty.
sellers are required to train any (3) Agency form number, if any, and
Public Comment employee who will be involved in the applicable component of the
To assist DEA in finalizing its selling scheduled listed chemical Department of Justice sponsoring the
Regulatory Impact Analysis, DEA is products and to document the training. collection: Form Number: DEA Form
seeking public comment on the Regulated sellers must also self-certify 597, Office of Diversion Control, Drug
following questions: to DEA that all affected employees have Enforcement Administration, U.S.
been trained and that the seller is in Department of Justice.
• What is the size of the market for
compliance with all CMEA provisions. (4) Affected public who will be asked
products regulated under this rule?
Finally, CMEA mandates that each sale or required to respond, as well as a brief
What proportion of the cold and allergy
at retail be documented in a written or abstract:
product market are pseudoephedrine-
electronic logbook and that the logbooks Primary: Business or other for-profit.
based products?
be retained for two years. Other: None.
• Using a pre-CMEA baseline, will Abstract: CMEA mandates that retail
this regulation have any effect on the The Department of Justice, Drug
Enforcement Administration, has sellers of scheduled listed chemical
prices of regulated products? If so, what products maintain a written or
is the magnitude of the change? submitted the following information
collection request to the Office of electronic logbook of sales, retain a
• How many retailers may choose not record of employee training, and
to carry the regulated products rather Management and Budget for review and
clearance in accordance with review complete a self-certification form
than incur the regulatory costs? What is verifying the training and compliance
their annual sales volume with regard to procedures of the Paperwork Reduction
Act of 1995. The information collection with CMEA provisions regarding retail
regulated products? What is the cost sales of scheduled listed chemical
associated with that effect? is published to obtain comments from
the public and affected agencies. products.
• If stores choose not to carry the (5) An estimate of the total number of
regulated products, what are consumers’ All comments and suggestions, or
respondents and the amount of time
travel costs associated with the questions regarding additional
estimated for an average respondent to
decreased quantity of stores selling the information, to include obtaining a copy
respond: 89,000, 25.9 hours.
product? of the information collection instrument
As discussed in the previous section,
• Placing products behind the with instructions, should be directed to
DEA estimates that the number of
counter may increase competition for Mark W. Caverly, Chief, Liaison and
potential regulated sellers could range
space behind the counter. Will it Policy Section, Office of Diversion
from 89,000 to 118,000. That number
increase the cost of storage space behind Control, Drug Enforcement
would include a substantial number of
the counter? What is the cost imposed Administration, Washington, DC 20537.
convenience stores, most of which may
on the consumption of other goods? Written comments and suggestions not find the burden of self-certification,
What, if any, effect will this have on the from the public and affected agencies storage, recordkeeping, and training
prices of other goods? concerning the collection of information worth the sales of items that represent
• Among stores that opt to direct are encouraged. Your comments on the a very small percentage of their overall
regulated transactions to their information collection-related aspects of sales. Thus, DEA expects that the
pharmacies, will this additional traffic this rule should address one or more of number of regulated sellers that will
have an effect on pharmacy wait times? the following four points: seek to self-certify will be no higher
Will the increase in pharmacy (1) Evaluate whether the collection of than 89,000. Consequently, DEA has
transactions require additional staffing? information is necessary for the proper used the lower estimate for the
• What equipment is required for performance of the functions of the information collection. The average
retailers who wish to handle regulated agency, including whether the annual burden hour per respondent is
sales at the regular checkout line? What information will have practical utility; 25.9 hours, most of which is the
is its cost? (2) Evaluate the accuracy of the additional time needed to record the
• What are wait times for regulated agency’s estimate of the burden of the statutorily mandated information on
transactions when two or more collection of information, including the each sales transaction.
consumers arrive to purchase regulated validity of the methodology and (6) An estimate of the total public
products? assumptions used; burden (in hours) associated with the
collection: 4,548,500 hours. The information and sign the log while the value of the market is the midpoint of
estimate includes both the burden hours sales person checks the photo ID will the estimates ($1 billion) and that the
for regulated sellers and the time take two minutes per transaction. DEA average value of a transaction is $8.
customers would take to provide assumes recordkeeping requirements (Product prices range from $4 to $14 per
information during the transaction. will not lengthen checkout lines, and package depending on the number of
Regulated sellers will need to will not influence the transaction times dosage units and strength.) The number
maintain a record of employee training, of other customers. Further, this of transactions was reduced to 67.25
self-certify, and maintain a logbook of estimate does not account for scenarios million to account for the states that
transactions. DEA estimates that each
in which two or more customers arrive already have requirements for logbooks;
regulated seller will spend 0.5 hours
to purchase scheduled listed chemical this rule imposes no additional burden
collecting the information and
completing the online self-certification products. DEA assumes that all for the transactions on either purchasers
form. Completing a roster of employees pharmacists and pharmacy technicians or sellers in those states. Based on
trained is estimated to take 3 minutes will be trained (about 300,000) plus Bureau of Census state population
per employee, assuming that the 100,000 other sales clerks. DEA used an numbers for 2005, these states represent
recordkeeping takes one tenth of the estimate of 133 million transactions to 49 percent of the United States
time spent on training. Finally, DEA develop total burden hours for population. Table 6 presents the burden
estimates that having the customer enter transactions, assuming that the total hour calculations.
TABLE 6.—ESTIMATE OF TOTAL BURDEN HOURS

Number of Total burden
Activity Unit burden hour activities hours
Training record ............................................................. 0.05 hour (3 minutes) ................................................... 400,000 20,000

Self-certification ............................................................ 0.5 hour (30 minutes) ................................................... 89,000 44,500
Transaction record ........................................................ 0.033 hour (2 minutes) ................................................. 67,250,000 2,242,000
Customer time .............................................................. 0.033 hour (2 minutes) ................................................. 67,250,000 2,242,000
Total ....................................................................... ....................................................................................... ........................ 4,548,500
If additional information is required deemed necessary under the provisions 801 pertaining to delayed effective dates
contact: Lynn Bryant, Department of the Unfunded Mandates Reform Act of major rules due to the limited time
Clearance Officer, Information of 1995. involved. Were DEA not to publish this
Management and Security Staff, Justice Interim Rule with Request for Comment,
Congressional Review Act
Management Division, Department of regulated sellers selling scheduled listed
Justice, Patrick Henry Building, Suite This rule is a major rule as defined by chemical products at retail would not be
1600, 601 D Street NW., Washington, section 804 of the Small Business able to self-certify by the date specified
DC 20530. Regulatory Enforcement Fairness Act of in the law. Were this not to occur, these
1996 (Congressional Review Act). This regulated sellers would be forced to stop
Executive Order 12988 rule may result in an annual effect on selling scheduled listed chemical
This regulation meets the applicable the economy of $100,000,000 or more; it products, or violate the law by doing so.
standards set forth in sections 3(a) and will not cause a major increase in costs
Mail order distributors would also have
3(b)(2) of Executive Order 12988 Civil or prices; or significant adverse effects
difficulty, as DEA is required by
Justice Reform. on competition, employment,
regulation to establish procedures for
investment, productivity, innovation, or
Executive Order 13132 these persons to identify their customers
on the ability of United States-based
This rulemaking does not impose companies to compete with foreign- prior to shipping product. Without these
enforcement responsibilities on any based companies in domestic and regulations, mail order distributors
State; nor does it diminish the power of export markets. Depending heavily on would not be able to sell scheduled
any State to enforce its own laws. The the assumptions used, the economic listed chemical products. Therefore,
rule does preempt State laws that are impact of this rule could be DEA also finds that it is contrary to the
less stringent than the statutory substantially higher or lower than public interest not to issue these
requirements. These requirements, $100,000,000. regulations as an Interim Rule, thereby
however, are mandated under CMEA CMEA requires that on and after allowing regulated sellers and mail
and DEA has no authority to alter them September 30, 2006, regulated sellers order distributors to fully comply with
or change the preemption. Accordingly, selling scheduled listed chemical the requirements of CMEA. While the
this rulemaking does not have products at retail shall self-certify with CMEA was signed into law in March of
federalism implications warranting the DEA in order to continue to sell these 2006, most of the law must be in effect
application of Executive Order 13132. products. CMEA imposes sales limits, by September 30, 2006. The broad scope
purchase limits, product placement of the new law, as well as the expedited
Unfunded Mandates Reform Act of 1995 requirements, mail order customer effective dates, is a clear reflection of
This rule will not result in the identification requirements, and other Congress’s concern about the nation’s
expenditure by State, local, and tribal requirements, some of which must be growing methamphetamine epidemic
governments, in the aggregate, or by the specified by regulation, all with an and its desire to act quickly to prevent
private sector, of $118,000,000 or more effective date of September 30, 2006. further illicit use of these chemicals. In
in any one year, and will not Based on the effective date of this law, light of these factors, DEA finds that
significantly or uniquely affect small it is impracticable for DEA to comply ‘‘good cause’’ exists to make this Interim
governments. Therefore, no actions were with the requirements of CRA section Rule with Request for Comment
effective September 21, 2006, except carriage in the lawful and usual course of sales, either directly to walk-in
that §§ 1314.20, 1314.25, and 1314.30 of the business of the common or customers or in face-to-face transactions
(with the exception of § 1314.30(a)(2)) contract carrier, or to or by a by direct sales. Also for the purposes of
are effective September 30, 2006. warehouseman for storage in the lawful this paragraph, a grocery store is an
Section 1314.30(a)(2) is effective and usual course of the business of the entity within Standard Industrial
November 27, 2006. warehouseman, except that if the Classification (SIC) code 5411, a general
carriage or storage is in connection with merchandise store is an entity within
List of Subjects the distribution, importation, or SIC codes 5300 through 5399 and 5499,
21 CFR Part 1300 exportation of a listed chemical to a and a drug store is an entity within SIC
third person, this paragraph does not code 5912.
Chemicals, Drug traffic control.
relieve a distributor, importer, or * * * * *
21 CFR Part 1309 exporter from compliance with parts (34)(i) The term scheduled listed
Administrative practice and 1309, 1310, and 1313 of this chapter; chemical product means a product that
(C) Any category of transaction or any contains ephedrine, pseudoephedrine,
procedure, Drug traffic control, Exports,
category of transaction for a specific or phenylpropanolamine and may be
Imports, Security measures.
listed chemical or chemicals specified marketed or distributed lawfully in the
21 CFR Part 1310 by regulation of the Administrator as United States under the Federal, Food,
Drug traffic control, Exports, Imports, excluded from this definition as Drug, and Cosmetic Act as a
Reporting and recordkeeping unnecessary for enforcement of the Act; nonprescription drug. Ephedrine,
(D) Any transaction in a listed
requirements. pseudoephedrine, and
chemical that is contained in a drug
phenylpropanolamine include their
21 CFR Part 1314 other than a scheduled listed chemical
salts, optical isomers, and salts of
Drug traffic control, Reporting and product that may be marketed or
optical isomers.
recordkeeping requirements. distributed lawfully in the United States
(ii) Scheduled listed chemical product
under the Federal Food, Drug, and
■For the reasons set out above, 21 CFR does not include any product that is a
Cosmetic Act, subject to paragraph
Chapter II is amended as follows: controlled substance under part 1308 of
(b)(28)(i)(E) of this section, unless—
this chapter. In the absence of such
(1) The Administrator has determined
PART 1300—DEFINITIONS scheduling by the Attorney General, a
pursuant to the criteria in § 1310.10 of
chemical specified in paragraph
■ 1. The authority citation for part 1300 this chapter that the drug or group of
(b)(34)(i) of this section may not be
continues to read as follows: drugs is being diverted to obtain the
considered to be a controlled substance.
listed chemical for use in the illicit
Authority: 21 U.S.C. 802, 871(b), 951, (35) The term regulated seller means
958(f). production of a controlled substance;
a retail distributor (including a
and
(2) The quantity of the listed chemical pharmacy or a mobile retail vendor),
■ 2. Section 1300.02 is amended by
contained in the drug included in the except that the term does not include an
revising paragraphs (b)(28) and (29),
transaction or multiple transactions employee or agent of the distributor.
removing paragraph (b)(31),
equals or exceeds the threshold (36) The term mobile retail vendor
redesignating paragraphs (b)(32) through
established for that chemical; means a person or entity that makes
(b)(34) as (b)(31) through (b)(33), and
(E) Any transaction in a scheduled sales at retail from a stand that is
adding new paragraphs (b)(34) through
listed chemical product that is a sale at intended to be temporary or is capable
(b)(37) to read as follows:
retail by a regulated seller or a of being moved from one location to
§ 1300.02 Definitions related to listed distributor required to submit reports another, whether the stand is located
chemicals. under § 1310.03(c) of this chapter; or within or on the premises of a fixed
* * * * * (F) Any transaction in a chemical facility (such as a kiosk at a shopping
(b) * * * mixture designated in §§ 1310.12 and center or an airport) or whether the
(28) The term regulated transaction 1310.13 of this chapter that the stand is located on unimproved real
means: Administrator has exempted from estate (such as a lot or field leased for
(i) A distribution, receipt, sale, regulation. retail purposes).
importation, or exportation of a listed (ii) A distribution, importation, or (37) The term at retail, with respect to
chemical, or an international transaction exportation of a tableting machine or the sale or purchase of a scheduled
involving shipment of a listed chemical, encapsulating machine except that such listed chemical product, means a sale or
or if the Administrator establishes a term does not include a domestic lawful purchase for personal use, respectively.
threshold amount for a specific listed distribution in the usual course of
chemical, a threshold amount as business between agents and employees PART 1309—REGISTRATION OF
determined by the Administrator, which of a single regulated person; in this MANUFACTURERS, DISTRIBUTORS,
includes a cumulative threshold amount context, agents or employees means IMPORTERS, AND EXPORTERS OF
for multiple transactions, of a listed individuals under the direct LIST I CHEMICALS
chemical, except that such term does management and control of the ■ 3. The authority citation for part 1309
not include: regulated person. continues to read as follows:
(A) A domestic lawful distribution in (29) The term retail distributor means
the usual course of business between a grocery store, general merchandise Authority: 21 U.S.C. 802, 821, 822, 823,
agents or employees of a single store, drug store, or other entity or 824, 830, 871(b), 875, 877, 958.
regulated person; in this context, agents person whose activities as a distributor ■ 4. Section 1309.71(a) is revised to read
or employees means individuals under relating to drug products containing as follows:

the direct management and control of pseudoephedrine or
the regulated person; phenylpropanolamine are limited § 1309.71 General security requirements.
(B) A delivery of a listed chemical to almost exclusively to sales for personal (a) All applicants and registrants must
or by a common or contract carrier for use, both in number of sales and volume provide effective controls and
procedures to guard against theft and illicit manufacture of a controlled in light of the comments and objections
diversion of List I chemicals. Chemicals substance. filed. Thereafter, the Administrator shall
must be stored in containers sealed in (b) An application for an exemption reinstate, revoke, or amend the original
such a manner as to indicate any under this section must contain all of order as deemed appropriate.
attempts at tampering with the the following information: ■ 11. Part 1314 is added to 21 CFR
container. Where chemicals cannot be (1) The name and address of the Chapter II to read as follows:
stored in sealed containers, access to the applicant.
chemicals should be controlled through (2) The exact trade name of the PART 1314—RETAIL SALE OF
physical means or through human or scheduled listed chemical product for SCHEDULED LISTED CHEMICAL
electronic monitoring. which exemption is sought. PRODUCTS
(3) The complete quantitative and
* * * * *
qualitative composition of the drug Subpart A—General
PART 1310—RECORDS AND product. 1314.01 Scope.
REPORTS OF LISTED CHEMICALS (4) A brief statement of the facts that 1314.02 Applicability.
AND CERTAIN MACHINES the applicant believes justify the 1314.03 Definitions.
granting of an exemption under this 1314.05 Requirements regarding packaging
■ 5. The authority citation for part 1310 section. of nonliquid forms.
(5) Certification by the applicant that 1314.10 Effect on state laws.
continues to read as follows:
the product may be lawfully marketed 1314.15 Loss reporting.
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890. or distributed under the Federal, Food, Subpart B—Sales by Regulated Sellers
Drug, and Cosmetic Act. 1314.20 Restrictions on sales quantity.
■ 6. In § 1310.04, paragraph (f)(1)(ii) is (6) The identification of any 1314.25 Requirements for retail
revised to read as follows: information on the application that is transactions.
considered by the applicant to be a trade 1314.30 Recordkeeping for retail
§ 1310.04 Maintenance of records. transactions.
secret or confidential and entitled to
* * * * * protection under U.S. laws restricting 1314.35 Training of sales personnel.
(f) * * * the public disclosure of such 1314.40 Self-certification.
(1) * * * information by government employees. 1314.45 Privacy protections.
(ii) For List I chemicals that are (c) The Administrator may require the 1314.50 Employment measures.
scheduled listed chemical products as applicant to submit additional Subpart C—Mail-Order Sales
defined in § 1300.02, the thresholds documents or written statements of fact
established in paragraphs (f)(1)(i) and (g) 1314.100 Sales limits for mail-order sales.
relevant to the application that he 1314.105 Verification of identity for mail-
of this section apply only to non-retail deems necessary for determining if the order sales.
distribution, import, and export. Sales application should be granted. 1314.110 Reports for mail-order sales.
of these products at retail are subject to (d) Within a reasonable period of time 1314.115 Distributions not subject to
the requirements of part 1314 of this after the receipt of a completed reporting requirements.
chapter. application for an exemption under this Subpart D—Order To Show Cause
* * * * * section, the Administrator shall notify 1314.150 Order to show cause.
■ 7. Section 1310.05 is amended by the applicant of acceptance or non- 1314.155 Suspension pending final order.
revising paragraph (f)(2) to read as acceptance of the application. If the
Authority: 21 U.S.C. 802, 830, 842, 871(b),
follows: application is not accepted, an
875, 877.
explanation will be provided. The
§ 1310.05 Reports.
Administrator is not required to accept Subpart A—General
* * * * * an application if any of the information
(f) * * * required in paragraph (b) of this section § 1314.01 Scope.
(2) Distributions of drug products by or requested under paragraph (c) of this This part specifies the requirements
retail distributors that may not include section is lacking or not readily for retail sales of scheduled listed
face-to-face transactions to the extent understood. The applicant may, chemical products to individuals for
that such distributions are consistent however, amend the application to meet personal use.
with the activities authorized for a retail the requirements of paragraphs (b) and
distributor as specified in (c) of this section. § 1314.02 Applicability.
§ 1300.02(b)(29) of this chapter, except (e) If the application is accepted for (a) This part applies to the following
that this paragraph does not apply to filing, the Administrator shall issue and regulated persons who sell scheduled
sales of scheduled listed chemical publish in the Federal Register an order listed chemical products for personal
products at retail. on the application, which shall include use:
* * * * * a reference to the legal authority under (1) Regulated sellers of scheduled
■ 8. Remove § 1310.14. which the order is based. This order listed chemical products sold at retail
■ 9. Remove § 1310.15. shall specify the date on which it shall for personal use through face-to-face
■ 10. Add § 1310.16 to read as follows: take effect. sales at stores or mobile retail vendors.
(f) The Administrator shall permit any (2) Regulated persons who engage in
§ 1310.16 Exemptions for certain interested person to file written a transaction with a non-regulated
scheduled listed chemical products. comments on or objections to the order. person and who ship the products to the
(a) Upon the application of a If any comments or objections raise non-regulated person by the U.S. Postal
manufacturer of a scheduled listed significant issues regarding any findings Service or by private or common
chemical product, the Administrator of fact or conclusions of law upon carriers.

may by regulation provide that the which the order is based, the (b) The requirements in subpart A
product is exempt from part 1314 of this Administrator shall immediately apply to all regulated persons subject to
chapter if the Administrator determines suspend the effectiveness of the order this part. The requirements in subpart B
that the product cannot be used in the until he may reconsider the application apply to regulated sellers as defined in
§ 1300.02 of this chapter. The Regulated Person maintained on paper or in electronic

requirements in subpart C apply to Registration number (if applicable) llll form.
regulated persons who ship the Name llllllllllllllllll (2) Effective November 27, 2006, if a
products to the customer by the U.S. Business address llllllllllll logbook is maintained on paper, it must
Postal Service or by private or common City llllllllllllllllll be created and maintained in a bound
carriers. State llllllllllllllllll record book.
Zip lllllllllllllllllll (b) The regulated seller must not sell
§ 1314.03 Definitions. Business phone lllllllllllll
Date of loss lllllllllllllll
a scheduled listed chemical product at
As used in this part, the term ‘‘mail- retail unless the purchaser does the
order sale’’ means a retail sale of Type of loss lllllllllllllll
Description of circumstances lllllll following:
scheduled listed chemical products for (1) Presents an identification card that
personal use where a regulated person Subpart B—Sales by Regulated Sellers provides a photograph and is issued by
uses or attempts to use the U.S. Postal a State or the Federal Government, or a
Service or any private or commercial § 1314.20 Restrictions on sales quantity. document that, with respect to
carrier to deliver the product to the (a) Without regard to the number of identification, is considered acceptable
customer. Mail-order sale includes transactions, a regulated seller for purposes of 8 CFR 274a.2(b)(1)(v)(A)
purchase orders submitted by phone, (including a mobile retail vendor) may and 274a.2(b)(1)(v)(B).
mail, fax, Internet, or any method other not in a single calendar day sell any (2) Signs the logbook and enters in the
than face-to-face transaction. purchaser more than 3.6 grams of logbook his or her name, address, and
§ 1314.05 Requirements regarding ephedrine base, 3.6 grams of the date and time of the sale.
packaging of nonliquid forms. pseudoephedrine base, or 3.6 grams of (c) For records created electronically,
A regulated seller or mail order phenylpropanolamine base in the regulated seller may use an
distributor may not sell a scheduled scheduled listed chemical products. electronic signature system to capture
listed chemical product in nonliquid (b) A mobile retail vendor may not in the signature and may have the
form (including gel caps) unless the any 30-day period sell an individual computer automatically enter the date
product is packaged either in blister purchaser more than 7.5 grams of and time of the sale. The regulated seller
packs, with each blister containing no ephedrine base, 7.5 grams of may ask the purchaser for their name
more than two dosage units or, if blister pseudoephedrine base, or 7.5 grams of and address and enter information if it
packs are technically infeasible, in unit phenylpropanolamine base in is not feasible for the purchaser to enter
dose packets or pouches. scheduled listed chemical products. the information electronically.
(d) The regulated seller must
§ 1314.10 Effect on State laws. § 1314.25 Requirements for retail
transactions. determine that the name entered in the
Nothing in this part preempts State logbook corresponds to the name
law on the same subject matter unless (a) Each regulated seller must ensure provided on identification presented
there is a positive conflict between this that sales of a scheduled listed chemical and that the date and time entered are
part and a State law so that the two product at retail are made in accordance correct.
cannot consistently stand together. with this section and § 1314.20. (e) The regulated seller must enter in
(b) The regulated seller must place the the logbook the name of the product and
§ 1314.15 Loss reporting. product so that customers do not have the quantity sold. Examples of methods
(a) Each regulated person must report direct access to the product before the of recording the quantity sold include
to the Special Agent in Charge of the sale is made (in this paragraph referred the weight of the product per package
DEA Divisional Office for the area in to as ‘‘behind-the-counter’’ placement). and number of packages of each
which the regulated person making the For purposes of this paragraph, a chemical, the cumulative weight of the
report is located, any unusual or behind-the-counter placement of a product for each chemical, or quantity
excessive loss or disappearance of a product includes circumstances in of product by Universal Product Code.
scheduled listed chemical product which the product is stored in a locked These examples do not exclude other
under the control of the regulated cabinet that is located in an area of the methods of displaying the quantity sold.
person. The regulated person facility where customers do have direct For electronic records, the regulated
responsible for reporting a loss in-transit access. Mobile retail vendors must place seller may use a point-of-sale and bar
is the supplier. the product in a locked cabinet. code reader. Such electronic records
(b) Each report submitted under (c) The regulated seller must deliver must be provided pursuant to paragraph
paragraph (a) of this section must, the product directly into the custody of (i) of this section in a human readable
whenever possible, be made orally to the purchaser. form such that the requirements of
the DEA Divisional Office for the area in
§ 1314.30 Recordkeeping for retail paragraph (a)(1) of this section are
which the regulated person making the
transactions. satisfied.
report is located at the earliest
(a)(1) Except for purchase by an (f) The regulated seller must include
practicable opportunity after the
individual of a single sales package in the logbook or display by the
regulated person becomes aware of the
containing not more than 60 milligrams logbook, the following notice:
circumstances involved.
(c) Written reports of losses must be of pseudoephedrine, the regulated seller Warning: Section 1001 of Title 18, United
filed within 15 days after the regulated must maintain, in accordance with States Code, states that whoever, with respect
person becomes aware of the criteria issued by the Administrator, a to the logbook, knowingly and willfully
written or electronic list of each falsifies, conceals, or covers up by any trick,
circumstances of the event. scheme, or device a material fact, or makes
(d) A report submitted under this scheduled listed chemical product sale
any materially false, fictitious, or fraudulent

section must include a description of that identifies the products by name, the statement or representation, or makes or uses
the circumstances of the loss (in-transit, quantity sold, the names and addresses any false writing or document knowing the
theft from premises, etc.). of the purchasers, and the dates and same to contain any materially false,
(e) A suggested format for the report times of the sales (referred to as the fictitious, or fraudulent statement or entry,
is provided below: ‘‘logbook’’). The logbook may be shall be fined not more than $250,000 if an
individual or $500,000 if an organization, the requirements that apply under this § 1310.03(c) of this chapter to submit a
imprisoned not more than five years, or both. part and agrees to comply with the report of the sales transaction to the
(g) The regulated seller must maintain requirements. Administration may not in a single
each entry in the logbook for not fewer (b) When a regulated seller files the calendar day sell to any purchaser more
than 2 years after the date on which the initial self-certification, the than 3.6 grams of ephedrine base, 3.6
entry is made. Administration will assign the regulated grams of pseudoephedrine base, or 3.6
(h) A record under this section must seller to one of twelve groups. The grams of phenylpropanolamine base in
be kept at the regulated seller’s place of expiration date of the self-certification scheduled listed chemical products.
business where the transaction for all regulated sellers in any group (b) Each regulated person who makes
occurred, except that records may be will be the last day of the month a sale at retail of a scheduled listed
kept at a single, central location of the designated for that group. In assigning a chemical product and is required under
regulated seller if the regulated seller regulated seller to a group, the § 1310.03(c) of this chapter to submit a
has notified the Administration of the Administration may select a group with report of the sales transaction to the
intention to do so. Written notification an expiration date that is not less than Administration may not in any 30-day
must be submitted by registered or 12 months or more than 23 months from period sell to an individual purchaser
certified mail, return receipt requested, the date of the self-certification. After more than 7.5 grams of ephedrine base,
to the Special Agent in Charge of the the initial certification period, the 7.5 grams of pseudoephedrine base, or
DEA Divisional Office for the area in regulated seller must update the self- 7.5 grams of phenylpropanolamine base
which the records are required to be certifications annually. in scheduled listed chemical products.
kept. (c) The regulated seller must provide
a separate certification for each place of § 1314.105 Verification of identity for mail-
(i) The records required to be kept
business at which the regulated seller order sales.
under this section must be readily
retrievable and available for inspection sells scheduled listed chemical products (a) Each regulated person who makes
and copying by authorized employees of at retail. a sale at retail of a scheduled listed
the Administration under the provisions chemical product and is required under
§ 1314.45 Privacy protections. § 1310.03(c) of this chapter to submit a
of 21 U.S.C. 880. To protect the privacy of individuals
(j) A record developed and report of the sales transaction to the
who purchase scheduled listed Administration must, prior to shipping
maintained to comply with a State law
chemical products, the disclosure of the product, receive from the purchaser
may be used to meet the requirements
information in logbooks under § 1314.15 a copy of an identification card that
of this section if the record includes the
is restricted as follows: provides a photograph and is issued by
information specified in this section. (a) The information shall be disclosed a State or the Federal Government, or a
§ 1314.35 Training of sales personnel. as appropriate to the Administration document that, with respect to
Each regulated seller must ensure that and to State and local law enforcement identification, is considered acceptable
its sales of a scheduled listed chemical agencies. for purposes of 8 CFR 274a.2(b)(1)(v)(A)
product at retail are made in accordance (b) The information in the logbooks and 274a.2(b)(1)(v)(B). Prior to shipping
with the following: shall not be accessed, used, or shared the product, the regulated person must
(a) In the case of individuals who are for any purpose other than to ensure determine that the name and address on
responsible for delivering the products compliance with this title or to facilitate the identification correspond to the
into the custody of purchasers or who a product recall to protect public health name and address provided by the
deal directly with purchasers by and safety. purchaser as part of the sales
obtaining payments for the products, the (c) A regulated seller who in good
transaction. If the regulated person
regulated seller has submitted to the faith releases information in a logbook
cannot verify the identities of both the
Administration a self-certification that to Federal, State, or local law
purchaser and the recipient, the person
all such individuals have, in accordance enforcement authorities is immune from
may not ship the scheduled listed
with criteria issued by the civil liability for the release unless the
chemical product.
Administration, undergone training release constitutes gross negligence or (b) If the product is being shipped to
provided by the regulated seller to intentional, wanton, or willful a third party, the regulated person must
ensure that the individuals understand misconduct. comply with the requirements of
the requirements that apply under this § 1314.50 Employment measures. paragraph (a) to verify that both the
part. A regulated seller may take reasonable purchaser and the person to whom the
(b) The regulated seller maintains a measures to guard against employing product is being shipped live at the
copy of each self-certification and all individuals who may present a risk with addresses provided. If the regulated
records demonstrating that individuals respect to the theft and diversion of person cannot verify the identities of
referred to in paragraph (a) of this scheduled listed chemical products, both the purchaser and the recipient,
section have undergone the training. which may include, notwithstanding the person may not ship the scheduled
State law, asking applicants for listed chemical product.
§ 1314.40 Self-certification.
(a) A regulated seller must submit to employment whether they have been § 1314.110 Reports for mail-order sales.
the Administration the self-certification convicted of any crime involving or (a) Each regulated person required to
referred to in § 1314.35(a) in order to related to such products or controlled report under § 1310.03(c) of this chapter
sell any scheduled listed chemical substances. must either:
product. The certification is not Subpart C—Mail-Order Sales (1) Submit a written report,
effective for purposes of this section containing the information set forth in
unless, in addition to provisions § 1314.100 Sales limits for mail-order paragraph (b) of this section, on or
regarding the training of individuals sales. before the 15th day of each month
referred to in § 1314.35(a), the (a) Each regulated person who makes following the month in which the
certification includes a statement that a sale at retail of a scheduled listed distributions took place. The report
the regulated seller understands each of chemical product and is required under must be submitted under company
letterhead, signed by the person to sales of scheduled listed chemical upon the seller or distributor required to
authorized to sign on behalf of the products at retail. file reports under § 1310.03(c) of this
regulated seller, to the Drug and (3) Distributions to a resident of a long chapter of an order to show cause why
Chemical Evaluation Section, Office of term care facility or distributions to a the regulated seller or distributor should
Diversion Control, Drug Enforcement long term care facility for dispensing to not be prohibited from selling
Administration, Washington, DC 20537; or for use by a resident of that facility. scheduled listed chemical products, in
or (4) Distributions in accordance with a any case where he finds that there is an
(2) Upon request to and approval by valid prescription. imminent danger to the public health or
the Administration, submit the report in (b) The Administrator may revoke any safety. If the Administrator so suspends,
electronic form, either via computer or all of the exemptions listed in he shall serve with the order to show
disk or direct electronic data paragraph (a) of this section for an cause under § 1314.150 an order of
transmission, in such form as the individual regulated person if the immediate suspension that shall contain
Administration shall direct. Requests to Administrator finds that drug products a statement of his findings regarding the
submit reports in electronic form should distributed by the regulated person are danger to public health or safety.
be submitted to the Drug and Chemical being used in violation of the (b) Upon service of the order of
Evaluation Section, Office of Diversion regulations in this chapter or the immediate suspension, the regulated
Control, Drug Enforcement Controlled Substances Act. seller or distributor shall, as instructed
Administration, Washington, DC 20537, by the Administrator:
ATTN: Electronic Reporting. Subpart D—Order to Show Cause (1) Deliver to the nearest office of the
(b) Each monthly report must provide § 1314.150 Order To show cause.
Administration or to authorized agents
the following information for each of the Administration all of the
distribution: (a) If, upon information gathered by scheduled listed chemical products in
(1) Supplier name and registration the Administration regarding any his or her possession; or
number; regulated seller or a distributor required (2) Place all of the scheduled listed
(2) Purchaser’s name and address; to submit reports under § 1310.03(c) of chemical products under seal as
(3) Name/address shipped to (if this chapter, the Administrator described in Section 304 of the Act (21
different from purchaser’s name/ determines that a regulated seller or U.S.C. 824(f)).
address); distributor required to submit reports (c) Any suspension shall continue in
(4) Method used to verify the identity under § 1310.03(c) of this chapter has effect until the conclusion of all
of the purchaser and, where applicable, sold a scheduled listed chemical proceedings upon the prohibition,
person to whom product is shipped; product in violation of Section 402 of including any judicial review, unless
(5) Name of the chemical contained in the Act (21 U.S.C. 842(a)(12) or (13)), sooner withdrawn by the Administrator
the scheduled listed chemical product the Administrator will serve upon the or dissolved by a court of competent
and total quantity shipped (e.g. regulated seller or distributor an order jurisdiction. Any regulated seller or
pseudoephedrine, 3 grams); to show cause why the regulated seller distributor whose right to sell scheduled
(6) Date of shipment; or distributor should not be prohibited listed chemical products is suspended
(7) Product name; from selling scheduled listed chemical under this section may request a hearing
(8) Dosage form (e.g., tablet, liquid); products. on the suspension at a time earlier than
(9) Dosage strength (e.g., 30mg, 60mg, (b) The order to show cause shall call specified in the order to show cause
per dose etc.); upon the regulated seller or distributor under § 1314.150, which request shall
(10) Number of dosage units (e.g., 100 to appear before the Administrator at a be granted by the Administrator, who
doses per package); time and place stated in the order, shall fix a date for such hearing as early
(11) Package type (blister pack, etc.); which shall not be less than 30 days as reasonably possible.
(12) Number of packages; after the date of receipt of the order. The
(13) Lot number. order to show cause shall also contain Dated: September 20, 2006.
a statement of the legal basis for such Michele M. Leonhart,
§ 1314.115 Distributions not subject to hearing and for the prohibition and a Deputy Administrator.
reporting requirements.
summary of the matters of fact and law [FR Doc. 06–8194 Filed 9–21–06; 10:25 am]
(a) The following distributions to asserted. BILLING CODE 4410–09–P
nonregulated persons are not subject to (c) Upon receipt of an order to show
the reporting requirements in cause, the regulated seller or distributor
§ 1314.110: must, if he desires a hearing, file a DEPARTMENT OF TRANSPORTATION
(1) Distributions of sample packages request for a hearing as specified in
when those packages contain not more subpart D of part 1316 of this chapter. National Highway Traffic Safety
than two solid dosage units or the If a hearing is requested, the Administration
equivalent of two dosage units in liquid Administrator shall hold a hearing at
form, not to exceed 10 milliliters of the time and place stated in the order, 49 CFR Part 593
liquid per package, and not more than as provided in part 1316 of this chapter.
one package is distributed to an [Docket No. NHTSA–2006–25686]
(d) When authorized by the
individual or residential address in any Administrator, any agent of the List of Nonconforming Vehicles
30-day period. Administration may serve the order to Decided To Be Eligible for Importation
(2) Distributions by retail distributors show cause.
that may not include face-to-face AGENCY: National Highway Traffic
transactions to the extent that such § 1314.155 Suspension pending final Safety Administration (NHTSA), DOT.
distributions are consistent with the order.

ACTION: Final rule.
activities authorized for a retail (a) The Administrator may suspend
distributor as specified in the right to sell scheduled listed SUMMARY: This document revises the list
§ 1300.02(b)(29) of this chapter, except chemical products simultaneously with, of vehicles not originally manufactured
that this paragraph (a)(2) does not apply or at any time subsequent to, the service to conform to the Federal motor vehicle

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56008 Federal Register / Vol. 71, No.

186 / Tuesday, September 26, 2006 / Rules and Regulations

30 mg Pseudoephedrine HCl ....................................................................................................................... 146 305 366

TABLE 2.—SUMMARY OF REQUIREMENTS BY TYPE OF SELLER

pseudoephedrine, or requirements for training of employees check photo identifications of

TABLE 3.—SELF-CERTIFICATION COSTS AND FEE CALCULATION

Planning 1 ................................................................................................................. $3,029 $36,343 $37,002 $76,373

Total .................................................................................................................. 117,198 1,624,443 1,099,782 2,841,423

Population ................................................................................................................ ...................... 89,000 89,000 ......................

process. Persons interested in this self- of several extraordinary factors. CMEA

TABLE 4.—SECTORS SELLING SCHEDULED LISTED CHEMICAL PRODUCTS

44511 Grocery stores ...................................................................... 66,150 19,721 26,029 70.2 1.30

Subtotal ..................................................................................... 114,946 66,282 67,359

44512 Convenience stores .............................................................. 29,212 370 12,399 98.7 1.60

Total .......................................................................................... 167,269 1,400 24,489–64,557

Because 16 States representing 27 scheduled listed chemical products.

TABLE 5.—STATE AND FEDERAL CLANDESTINE LABORATORY CLEANUP COSTS

1998 ............................................................................................................................................. $4,030,000 $1,420,000 $5,450,000

TABLE 6.—ESTIMATE OF TOTAL BURDEN HOURS

Training record ............................................................. 0.05 hour (3 minutes) ................................................... 400,000 20,000

Total ....................................................................... ....................................................................................... ........................ 4,548,500

or employees means individuals under relating to drug products containing as follows:

chemical product, the Administrator of fact or conclusions of law upon carriers.

§ 1300.02 of this chapter. The Regulated Person maintained on paper or in electronic

any materially false, fictitious, or fraudulent

distributions are consistent with the order.

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