COMPREHENSIVE AMENDMENTS TO

BOARD REG. NO.3 SERIES 2003

BOARD REGULATION
NO 1, SERIES 2014

ROSEL G. SARMIENTO, RPh

Dangerous Drugs Regulations Officer II
PDEA CAR
 - LEGAL MANDATE -

Republic Act 9165

Comprehensive Dangerous Drugs Act of 2002
Reorganization of the Philippine
Drug Enforcement System
Creation of
The new Dangerous Drugs
Board (DDB) as the policy
and strategy formulating
body.

The Philippine Drug Enforcement

Agency (PDEA) as its
implementing arm.
01
 BOARD REGULATION NO. 1
SERIES OF 2014

Comprehensive Amendments to
Board Regulation No. 3 Series 2003,

Comprehensive Guidelines on Importation,

Distribution, Manufacture, Prescription,
Dispensing and Sale of, and other Lawful
Acts in Connection with Any Dangerous
Drugs, Controlled Precursors and Essential
Chemicals and Other Similar or Analogous
Substances

Implementation Effective March 13,

2015
 DEFINITION OF TERMS

1. ADMINISTER means any act of introducing any

dangerous drug into the body of any person or
animal, with or without his/her knowledge by
injection, inhalation, ingestion or other means
or of committing any act of indispensable
assistance to a person in administering a
dangerous drug to himself/ herself unless
administered by a duly-licensed practitioner for
purposes of medication.
2. DIVERSION OF DANGEROUS DRUGS
means the unlawful obtaining and
channeling of pharmaceutical dangerous
drugs for illegal purposes among others,
e.g. in drug dens, dives or resorts and
other places by methods such as forged
or altered prescriptions, feigning
sickness and obtaining prescription from
medical practitioners, theft, and robbery,
over-prescription by medical
practitioners, doctors shopping,
collection of drug leftovers and unused
prepared parenteral dose in hospitals,
obtaining drugs via e-mail and post, and
use of invalidated local order form
instead of prescription form.
3. LICENSE means a written permission or
authorization
i) S-license refers to dangerous drugs and
their preparations and authorized activities for
holders;
ii) P-license refers to controlled precursors
and essential chemicals and mixtures and
authorized activities for holders.

4. MEDICAL PRACTITIONER means any

person who is registered and entitled under the
laws of the Philippines to practice the
profession of medicine, to include dentistry
and veterinary medicine.
5. PERMIT means an authorization granted
in writing
by the PDEA Director General or his
authorized representative to a license holder
for the importation and other activities
requiring such a permit, of a controlled
substance.

6. SUPPLY includes sale, shipment,

dispatch, transport, delivery, distribution,
dispensing, as well as offer stock.
 S-2 License

Permanent No. Year issued Control No.

(Temporary S2 # does not possess
control no.)

S2 No: ######NM15- ###R -

L# If lost, as
reported
Where N = New Region where S2 license
or R = Renewal paid
or E = Exempt Where M =Medical
Practitioner/Physician
or D =Dentist
or V =Veterinarian
SYNCHRONIZED WITH PRC
 a surcharge of P500.00 per year shall be imposed
for failure to renew the license within the period
covered.

To avoid surcharges, licensee must notify PDEA in

writing regarding its intention not to renew their license
after expiration

An S2 license shall remain in force for a period

conforming with the validity of the licensees registered
PRC

Prescribing not in accordance with existing rules and

regulations is subject to suspension or revocation of
license at any time.
S2 CERTIFICATES
HOW TO APPLY FOR AN S2
LICENSE
Incompletely filled- out
application form will not be
processed

Indicate if NEW or
RENEWAL
Old S2-license for
surrender
PRC

PTR (private practitioner)

COE & affidavit (Govt
practitioner
TIN/ITR for new applicants
only
Drug test- DOH
accredited
1pc 2x2 picture

signature

Submit 2 sets of application

 PRESCRIBING

No Medical practitioner shall prescribe a

dangerous drug in any form without a valid
S-2 license issued by the PDEA.
No person shall prescribe a dangerous drug
which requires a valid S-2 license, unless
that person is a medical practitioner.

A medical practitioner, in accordance with the norms and

standards of his or profession, is authorized to administer a
drug directly to a patient in the ordinary course of treatment
or supplies the drug to a patient from a place more than
five(5) kilometer-radius from the place of business of a
pharmacy.
 Standard Information to be supplied in
the prescription
PRESCRIBING PHYSICIAN INFROMATION
i. The full name of prescribing physician
ii. complete address, telephone #/ email address
iii. current S-2 license number and validity of
license
iv. PRC license number
v. Professional Tax Receipt of the prescribing
PATIENT INFORMATION
physician
i. Complete name of patient
ii. address of patient

Other important information

i. date of prescription
ii. generic and brand name of dangerous drugs, its
dosage strength and form
iii. quantity of dangerous drugs to be supplied in words
and its numerical equivalent
iv. direction of use
v. incription of no refill at the face of the prescription
vi. original signature of the prescribing physician
 A prescription for a dangerous drug shall:

a) Be on a SPFDD unless specifically exempted

b) be signed and dated by the prescribing

practitioner on the date of issue

c) contain only 1 dangerous drug

d) be issued in triplicate copies with specific

direction of use

e) Direction of use must be specified

f) take as directed or take as required is not

authorized
 Prescription Restrictions and or
Exemptions

Multi-month Patches of Buprenorphine- to

Prescription/ be prescribed in ordinary
90 day -supply prescription in triplicate form
-psychotropics only
All oral forms of FDA-
60 day-supply registered drug preparations in
-for treatment of Phil. Schedule 4 & 5 must be
epilepsy & dystonia prescribed in an ordinary
prescription in triplicate form
30 day-supply
-Phil, Schedules 2,3 SPFDD issued to physicians,
and 4 veterinarian, dentist,
possessing a valid S2-license
as necessary are non-transferrable and
-Phil. Schedule 5 accountable forms and shall be
 Prescription Limits
Pres

X
D c ript
R.
AIN LOREN
T FR Z
ANC O LOR
ion
10 ISH E
F3 OSP NS
ITAL
NAM
DAT E:_____
E _
ADD :05/01 _______
Prescription
____
/
____ RESS__ 2015
____
__ _ LOR_EN S
DR. LORENZ_O ____ ___
AINT FRANCIS H
OS_PI ___L_
__TA
____ 2
____
____
__
0F 3
___
NAME:__________
5
DATE:05/01/201
__ __ __
ADDRESS____ ___
__ ________________
________________ /201 5
d on 06/01
To be purchase
i pt i o n
r
Pre. LsORcENZO LOORSEPINTSAL 3
DR H
T F RANCIS
AIN

2015
0F 3 T E :0 5/01/
_ DA
_ _____ _ _
:_ _ __ _ __ ___ ___
NAME SS________ __________
E __
ADDR __________
_ _
______
 USE OF SPFDD/ YELLOW PADS

A practitioner possessing a valid S2 license can

purchase ten (10) booklets of SPFDD at a time from
the DOH or its official sites

SPFDDs are non transferrable and accountable

forms. These shall be for the exclusive use of the
physician to whom such forms are issued and shall be
used consecutively.

Unused SPFDD shall be immediately

surrendered to DOH

Licensed practitioners shall keep the used prescription

booklet in a separate file in such manner as to be
readily accessible to inspection by PDEA.
ORDINARY SPFDD
Rx with S2

Benzodiazepines Philippine Schedule 2 and

5
Phenobarbital (narcotics, nalbuphine and
ketamine)
Phentermine

Zolpidem

Buprenorphine
UNLAWFUL ACTS AND
PENALTIES
1. UNNECESSARY PRESCRIPTION OF
DANGEROUS DRUGS
-prescribing of dangerous drugs to any person
whose physical or physiological condition
does not require the use or in the dosage
prescribed therein

Sec 18 Art II of R.A 9165

The penalty of imprisonment ranging
from twelve(12) years and one(1) day to
twenty (20) years and a fine ranging
from One Hundred thousand pesos
(p100,000.00) to Five hundred thousand
pesos (p500,000.00)
2. UNLAWFUL PRESCRIPTION OF
DANGEROUS DRUGS
-unless authorized by law, shall make or
issue a prescription or any other writing
purporting to be a prescription for any
dangerous drug.

Sec 19 Art II of R.A 9165

The penalty of life imprisonment to
death and fine ranging from Five
hundred thousand pesos(p500,000.00)
to Ten Million pesos (p10,000,000.00)
 Section 32 of RA 9165

Liability to a person Violating Any Regulation

Issued by the Board:

Penalty of imprisonment ranging from six (6) months

and one (1) day to four (4) years and
a fine ranging from ten thousand pesos (P10,000.00)
to fifty thousand pesos (P50, 000.00)
shall be imposed upon any person
found violating any regulation duly issued by the
Board.
PHILIPPINE SCHEDULES SCHEDULES TABLES SEC 93
SCHEDULE UNDER 1961 UNDER 1971 UNDER THE ARTICLE XI
S UN UN 1988 R.A. 9165
CONVENTION CONVENTION UN
CONVENTION

SCHEDULE
1

SCHEDULE SCHEDULE 1 SCHEDULE II

2 (NARCOTICS) (METHYLPHENIDATE)

SCHEDULE SCHEDULE III

3 (BUPRENORPHINE,PE
NTOBARBITAL)

SCHEDULE SCHEDULE IV
4 (PSYCHOTROPICS)

SCHEDULE TABLE I NALBUPHINE

5 (EPHEDRINE, KETAMINE
PSEUDOEPHEDRINE)
 DISPENSING

ONLY AN AUTHORIZED PHARMACIST CAN ISSUE A

SUPPLY OF DANGEROUS DRUGS IN A HOSPITAL THRU:

a) Valid prescription
b) requisition sheet
i. shall be legible
ii. Specify complete name of the practitioner
iii. specify name, qty, form and strength of the
drug
iv. Specify the ward or dispensary where drug
is required
v. originally signed and dated by the nurse and
medical practitioner
vi. Countersigned by the pharmacist who
supply the drugs
 REQUISITION SHEET
Shall bear the Hospital
Heading

Date

Provide Requisition # for

easy reference

only one drug preparation

per requisition

Signed by the ward Nurse

Conformed by the Physician

Pharmacists Decision

Signature of the receiving

Nurse
 ADMINISTRATION SHEET

Drug Administration information, to

be filled up by the ward NURSE

Remarks: qty of
unused, verbal order,
Signed by the ward out of stock procured
nurse before from another
Reference to submission to pharmacy outside the
requisition sheet pharmacist hospital
 ADMINISTRATION SHEET
-controlled drug to be administered to patients from
unit dose or ward must be written for periods not to
exceed one (1) day

-information on the administration sheet:

i. date and time of administration
ii. Patients full name, hospital i.d. #, room/ bed #
iii. name of prescribing physician, s2 license &
signature
iv. Name of administering nurse, PRC license# &
signature
v. dose administered
vi. Inventory column
vii. Remarks( qty unused portion, emergency case,
verbal order, out of stock procured from another
pharmacy outside the hospital
 DANGEROUS DRUGS
ADMINISTRATION

Administration of parenteral drugs to patients

should be performed by at least one registered
nurse and witnessed by a competent other

The order to the nurse on duty by the

attending physician shall always be in writing
unless in emergency situations.
The word administered shall be written
following administration of the dangerous drug.

For oral dangerous drugs, the patient should

be observed swallowing the medication
Dangerous drugs must not be lent or
borrowed between departments/units/wards.

They should only be removed from medical

cart for immediate administration to patient.

When a dangerous drug is procured outside

the hospital,
the drug shall be turned over to the hospital
ward nurse
for the purpose of safekeeping and recording
of administration in patients clinical chart.
 STORAGE REQUIREMENT

The storage area should be sheltered; fenced-up;

under lock and key:

Hospitals/ institutional dispensers shall safeguard

drugs as follows:
1. Storage of bulk controlled substances must be in
the main pharmacy vault or cabinet

2. Controlled substances must be stored separate

from non-dangerous drugs stock.
 MEDICATION CARTS

1. DOUBLE KEYED LOCKS

2. WHEN NOT IN USE, ANCHORED TO A FLOOR

OR WALL DEVICE OR MAINTAINED IN ANOTHER
SECURE LOCATION

3. LOCKED DRAWER SYSTEM

4. INDEPENDENT LOCKING DEVICE

 DISPOSAL OF CONTROLLED
SUBSTANCES
For hospitals,
a) individual doses of dangerous drugs which are
prepared but not administered;

b) syringe contents of partly-used ampules;

c) residual unused content of dangerous drugs in

ampules and vials;

b) unused volumes of infusions; unused and unopened

or out of date products

shall be returned to the issuing

pharmacy for recording, and proper
disposition
 CONDUCT OF INSPECTION

1. Examine any label, advertising material,

register/book, records, electronic data or any other
pertinent document therein relating to any
controlled substance

2. take an extract of the record or pertinent

document or take a copy thereof and require from
the head of entity and authorized signatory a
notarized explanation of an entry in any such
register, record or document

3. seal and seize containers containing controlled

substances found to be not properly documented
or authorized.
Any Questions!