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R. A. No.

6675
September 13,1988

GENERICS ACT OF 1988

An act to promote, require, and ensure the production of an


adequate supply, distribution, use, and acceptance of drugs
and medicines identified by their generic names

Policy of the S TATE


To promote, encourage and require the use of generic terminology in
the importation, manufacture, distribution, marketing, advertising and
promotion, prescription and dispensing of drugs
To ensure the adequate supply of drugs with generic names at the
lowest possible cost and endeavor to make them available for free to
indigent patients
To encourage the extensive use of drugs with generic names
through a rational system of procurement and distribution
To emphasize the scientific basis for the use of drugs, in order that
health professionals may become more aware and cognizant of their
therapeutic effectiveness
To promote drug safety by minimizing duplication in medications
and/or use of drugs with potentially adverse drug interactions
DEFINITION OF TERMS
the identification of drugs and medicines by their scientifically and
internationally recognize active ingredients or by their official
generic name as determined by the BFAD.
is the chemical component responsible for the claimed therapeutic
effect of the pharmaceutical product
DEFINITION OF TERMS
is the description of the chemical structure of the drug or medicine and
serves as the complete identification of a compound

DEFINITION OF TERMS
is the finished product form that contains the active ingredients ,
generally but not necessarily in association with inactive ingredients
DEFINITION OF TERMS
DEFINITION OF TERMS
DEFINITION OF TERMS
DEFINITION OF TERMS
DEFINITION OF TERMS

E.O. 49

January 21, 1993

Directed mandatory use of the PNDF (Volume 1 or the Essential Drug


List)
Basis for procurement of drug products by government
A.O. 163 s. 2002
Implementing Guidelines and Procedures in the Procurement and
Requisition of Drugs and Medicines by the DOH pursuant to E.O. 49

A.O. 2012-0023

Replacement of the name PNDF PNF


Revision of the of the National Formulary Committee (NFC) to
Formulary Executive Council (FEC)
Detailing of the selection processes for the inclusion an deletion of
medicines
SEC 6. Who shall use Generic Terminology

As amended:

(e) There shall be appear prominently on the label of a generic drug the
following statement: THIS PRODUCT HAS THE SAME THERAPEUTIC
EFFICACY AS ANY OTHER GENERIC PRODUCT OF THE SAME
NAME, SIGNED: BFAD.

Sec. 8 is hereby amended

1.

SEC

8. Required Production:

Subject to the rules and regulations promulgated by the Secretary of Health,


every drug manufacturing company operating in the Philippines shall be
required to produce, distribute and make widely available to the general public
an unbranded generic counterpart of their branded product
GENERIC NAMES SHALL BE USED IN ALL PRESCRIPTIONS
1.1. For drugs with a single active ingredient,
the generic name of that active
ingredient
shall be used in prescribing
1.2. For drugs with two or more active
ingredients, the generic name as determined
by BFAD shall be used in prescribing

2.
THE GENERIC NAME MUST BE WRITTEN IN FULL BUT THE SALT OR CHEMICAL FORM MAY BE ABBREVIATED
3. THE GENERIC NAME OF THE DRUG ORDERED MUST BE CLEARLY WRITTEN ON THE
PRESCRIPTION IMMEDIATELY AFTER THE Rx SYMBOL, OR ON THE ORDER CHART
3.1. In addition to the generic name, a brand name may also be indicated. In such cases,
the following shall be observed:
3.1.1. If written on a prescription pad, the
brand name enclosed in parenthesis shall be
written below the generic name
3.1.2. If written on a patients chart, the
brand name enclosed in parenthesis shall be
written after the generic name
4. ONLY ONE DRUG SHALL BE PRESCRIBED

ON ONE PRESCRIPTION FORM

THINGS TO REMEMBER WHEN BUYING MEDICINES TO CHECK IF IT IS REGISTERED WITH BFAD-DOH AND IF IT
COMPLIES WITH GENERIC LABELING
Bottle/Box (Syrup, Tablet, Capsule, Injectable, Ointment)
- Generic name / Brand name
- Dosage strength / form
- Pharmacologic category
- Company logo
- Name / Address of company
- Rx symbol if prescription drugs
- Net content

Formulation
Indication / Dosage
Warning / contraindication / precaution
DR number
Expiry date
Batch number / Lot number
Manufacturing date
Storage condition

Foil/blister (Tablet, capsule)


- Generic name
- Brand name
- Dosage from / strength
- Company logo or name of
company
- Rx symbol if prescription drugs
- Expiry date / Lot number

Two

CLASSIFICATION OF DRUGS

broad legal classification of medications


Prescription or Ethical Drugs
Non-Prescription Drugs or OTC Drugs

Prescription or Ethical Drugs


Pharmaceutical products or drug preparations dispensed upon written
order of a validly-registered licensed physician, dentist or veterinarian
for the management or treatment of a condition or disease.

Prescription or Ethical Drugs

All antibiotics except some ointments


All injectables (ampules or vials)
Cough syrups containing any amount of narcotics (except dextromethorphan)
Vitamin products containing more than 10,000 units of Vitamin A
Highly potent drugs for special medication (ex. steroids, digitoxin)
Paregoric Elixir (in emergency cases, 1 dose may be dispensed without a prescription)
All drugs bearing the Rx symbol on their labels

All prescriptions dispensed in the drugstore, botica or hospital


pharmacy

Shall be kept in file for two years & recorded in a Rx book duly registered by FDA
Shall be open for inspection to Food & Drug Inspectors at any time during business hours of the
outlet.
Rx book shall be kept for two years after the last entry

Non-Prescription or OTC Drugs

Pharmaceutical products or drug preparations that can be dispensed even without the
written order of a validly-registered
validly-registered licensed physician, dentist or veterinarian
for the use of consumers for the prevention or symptomatic relief of minor or self-limiting
ailments.

Non-Prescription or OTC Drugs

Multivitamin products of low dosage


Anti-TB drugs except injectables
Cough syrups containing dextromethorphan
Household remedies except paregoric
Simple analgesics (Aspirin, Acetaminophen, etc.

DANGEROUS DRUGS
Refer to:
Prohibited Drugs
Regulated Drugs
-

Require a special Rx form


Use is monitored by the DDB

DANGEROUS DRUGS
Prohibited Drugs

Include:

opium & its active components & derivatives:


- heroin & morphine

cocoa leaf & its derivatives


- cocaine alpha & beta Eucaine
- hallucinogenic drugs mescaline,
lysergic acid diethylamide (LSD) &
other substances producing similar effects

Indian hemp & its derivatives

All preparations made from any of the foregoing

Other drugs, natural or synthetic, with the physiological effects of a narcotic drug

DANGEROUS DRUGS
Prohibited Drugs
DANGEROUS DRUGS
Regulated Drugs

Include:

Sleep-inducing sedatives
- secobarbital, phenobarbital, barbital,
amobarbital

Other drugs containing a salt or derivative of a salt of

Any salt, isomer or salt of an isomer of amphetamine


- benzedrine or dexedrine
- any drug which produces a pharmacologic action

Hypnotic drugs
- methaqualone or any other compound producing

barbituric acid

similar to amphetamine
similar pharmacologic effects

DANGEROUS DRUGS
Regulated Drugs
DANGEROUS DRUGS
Regulated Drugs
Requirements in the dispensing & compounding of dangerous
drugs

They should be prescribed in special Rx forms issued by the DDB.


DDB.
The pharmacist must record them in the Dangerous Drugs Book in accordance with the form prescribed
by the DDB.
The pharmacist must check all the required data as opium license number of the physician, profl
license number, and the residence certificate of the buyer.

The pharmacist must keep these dangerous drugs in a locked cabinet.


cabinet.

Requirements in the dispensing & compounding of dangerous


drugs

The pharmacist must keep and file the original Rx.


Quarterly report covering 3 calendar months of all transactions (copy of (2) to
be submitted to the Municipal Health Officer within 15 days following the
last day of every quarter of the year.

List of Products
Use
List of Products
Use
List of Products
Use
List of Products
Use
List of Products
Use
DISPENSING

Requiring Strict Precaution in Prescribing, Dispensing &


Requiring Strict Precaution in Prescribing, Dispensing &
Requiring Strict Precaution in Prescribing, Dispensing &
Requiring Strict Precaution in Prescribing, Dispensing &
Requiring Strict Precaution in Prescribing, Dispensing &

is the act by validly registered Pharmacist of


or doctors order on the patients chart.

a prescription

GENERIC DISPENSING
means dispensing the patients/ buyers choice among the generic equivalents, i.e. finished
pharmaceutical products having the same active ingredient(s) same dosage form and same
strength as the prescribed drug
PARTIAL FILLING OF Rx

means dispensing less than the total number of units prescribed

IV. In dispensing drugs in List A and List B:

4. After the Rx is filled the original copy of the


year by the pharmacist for inspection.

Rx shall be retained & kept for a period of 1

Form used when prohibited and or regulated drugs are prescribed.


No prescription once issued may be refilled. (Sec. 25, R.A.6425, as amended)
Original form shall be retained by the drugstore pharmacist for a period of one (1) year from the date of sale
or delivery of the drug herein prescribed

1 copy retained by the buyer or by the person to whom the drug is delivered until such drug is
consumed.

2nd copy shall be retained by the person issuing the prescription (Sec. 25, R.A. 6425, as amended)

New Law Sec 12 as amended

Exercise 1
Prescription without specification on the Generic name of the prescribed
product is a violation of:

A. R.A. 5921
B. R.A. 3720
C. R.A. 6675
D. R.A. 8203
Exercise 2
An act to promote, require, and ensure the production of an adequate supply,
distribution, use and acceptance of drugs and medicines identified by their
generic names
A.
B.
C.
D.

R.A. 3720
R.A. 5921
R.A. 6675
R.A. 9502

Exercise 3
Sudafed 200 mg Tablet prescription is
A. Violative prescription
B. Erroneous prescription
C. Impossible prescription
D. Intentional prescription

Exercise 4
The objective of Generic Law is to
A. provide regulated drugs
B. use of habit forming drugs
C. provide prohibited drugs
D. provide the patient choice of the drug at the lowest cost
Exercise 5
Considered as violative Rx
A. Mefenamic (Ponstan)
B. Ibuprofen (Brufen)
C. Nystatin (Mycostatin)
D. Rx Loviscol