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Paelmo Pharmacology 2FMT

1. Differentiate a)non-prescription/over-the counter drug, b)prescription,

c)regulated and d)prohibited drugs.
A) Over-the counter drug/non prescription

-Drugs that do not require a doctors prescription

-Bought off the shelf in stores

-Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of
"recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs
will continually be updated adding additional ingredients and labeling as needed. Products
conforming to a monograph may be marketed without further FDA clearance, while those that do
not, must undergo separate review and approval through the "New Drug Approval System."
Republic Act No. 9502 June 6, 2008
Amending RA8293, RA6675, RA5921

AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING

FOR THE PURPOSE REPUBLIC ACT NO. 8293 OR THE INTELLECTUAL
PROPERTY CODE, REPUBLIC ACT NO. 6675 OR THE GENERICS ACT OF 1988,
AND REPUBLIC ACT NO. 5921 OR THE PHARMACY LAW, AND FOR OTHER
PURPOSES

SEC. 2. Declaration of Policy. - It is the policy of the State to protect public health and, when
the public interest or circumstances of extreme urgency so require, it shall adopt appropriate
measures to promote and ensure access to affordable quality drugs and medicines for all.

Pursuant to the attainment of this general policy, an effective competition policy in the supply
and demand of quality affordable drugs and medicines is recognized by the State as a primary
instrument. In the event that full competition is not effective, the State recognizes as a reserve
instrument the regulation of prices of drugs and medicines, with clear accountability by the
implementing authority as mandated in this Act, as one of the means to also promote and ensure
access to quality affordable medicines.

CHAPTER 7

AMENDMENTS TO REPUBLIC ACT NO. 5921, AS AMENDED, OTHERWISE KNOWN

AS THE PHARMACY LAW

SEC. 43. Section 25 of Republic Act No. 5921, as amended, otherwise known as the Pharmacy
Law, is hereby amended to read as follows:

"SEC. 25. Sale of medicine, pharmaceuticals, drugs and devices. - No medicine,

pharmaceutical, or drug, except for those which are non-prescription or over-the-counter,
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of whatever nature and kind or device shall be compounded, dispensed, sold or resold, or
otherwise be made available to the consuming public except through a prescription
drugstore or hospital pharmacy, duly established in accordance with the provisions of this
Act. Non-prescription or over-the-counter drugs may be sold in their original packages,
bottles, containers or in small quantities, not in their original containers to the consuming
public through supermarkets, convenience stores and other retail establishments.

B) Prescription drugs

-Prescribed by a doctor
-Bought at a pharmacy
-Prescribed for and intended to be used by one person
Regulated by FDA through the New Drug Application (NDA) process. This is the formal step
a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the
United States. An NDA includes all animal and human data and analyses of the data, as well
as information about how the drug behaves in the body and how it is manufactured. For more
information on the NDA process, please see "The FDA's Drug Review Process: Ensuring
Drugs Are Safe and Effective."
CHAPTER 6

AMENDMENTS TO REPUBLIC ACT NO. 6675, OTHERWISE KNOWN AS THE

GENERICS ACT OF 1988

SEC. 38. Section 6 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is
hereby amended to read as follows:

"SEC. 6. Who Shall Use Generic Terminology. - (a) All government health agencies and
their personnel as well as other government agencies shall use generic terminology or
generic names in all transactions related to purchasing, prescribing, dispensing and
administering of drugs and medicines.

"(b) All medical, dental and veterinary practitioners, including private practitioners, shall
write prescriptions using the generic name. The brand name may be included if so
desired.

"(c) Any organization or company involved in the manufacture, importation, repacking,

marketing and/or distribution of drugs and medicines shall indicate prominently the
generic name of the product. In the case of brand name products, the generic name shall
appear prominently and immediately above the brand name in all product labels as well
as in advertising and other promotional materials.
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"(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and
nontraditional outlets such as supermarkets and stores, shall inform any buyer about any
and all other drug products having the same generic name, together with their
corresponding prices so that the buyer may adequately exercise his option. Within one (1)
year after the approval of this Act, the drug outlets referred to herein shall post in
conspicuous places in their establishments a list of drug products with the same generic
name and their corresponding prices.

"(e) There shall 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."

C) Regulated drugs

- Drugs that arent prohibited to the public since its therapeutic usefulness outweighs its bad
effects but still needs to be regulated .

REPUBLIC ACT No. 6425 April 4, 1972

THE DANGEROUS DRUGS ACT OF 1972

Section 1. Short Title. This Act shall be known and cited as "The Dangerous Drugs Act of 1972."

ARTICLE I
Definition of terms

Section 2. Definitions. As used in this Act, the term:

"Regulated drug," which includes self-inducing sedatives, such as secobarbital, phenobarbital,

pentobarbital, barbital, amobarbital and any other drug which contains a salt or a derivative of a
salt of barbituric acid; any salt, isomer or salt of an isomer, of amphetamine, such as benzedrine
or dexedrine, or any drug which produces a physiological action similar to amphetamine; and
hypnotic drugs, such as methaqualone or any other compound producing similar physiological
effects;

D) Prohibited drugs

-Drugs with toxicity or side-effects that outweigh their therapeutic usefulness, so that public
health welfare are protected by prohibiting their production, manufacture, export, import, trade,
distribution, supply, possession or use, except in amounts required for medical and cure.
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REPUBLIC ACT No. 6425 April 4, 1972

THE DANGEROUS DRUGS ACT OF 1972

Section 1. Short Title. This Act shall be known and cited as "The Dangerous Drugs Act of 1972."

ARTICLE I
Definition of terms

Section 2. Definitions. As used in this Act, the term:

(1) "Prohibited drug," which includes opium and its active components and derivatives, such as
heroin and morphine; coca leaf and its derivatives, principally cocaine; alpha and beta eucaine;
hallucinogenic drugs, such as mescaline, lysergic acid diethylamide (LSD) and other substances
producing similar effects; Indian hemp and its derivates; all preparations made from any of the
foregoing; and other drugs, whether natural or synthetic, with the physiological effects of a
narcotic drug; or

2. Differentiate drug from a) food supplements and b) traditional herbal

medicine.

A) Food Supplements

-Non food substances that are used to augment the dietary intake of minerals, vitamins,
amino acids etc.

Republic Act No. 9711 August 18, 2009

AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF

THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE
TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT,
AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO
RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION
(FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED,
AND APPROPRIATING FUNDS THEREOF
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Be it enacted by the Senate and House of Representatives of the Philippines in Congress

assembled::

Section 9. Section 10, subsections (a), (e), (f), (g), (h), (i), (q),(r), (v), and (w) of Republic
Act No. 3720, as amended, are hereby further amended, and new subsections (x), (y), (z),
(aa), (bb), (cc), (dd), (ee), (ff), (gg), (hh), (ii), (jj), (kk), (ll), and (mm) are hereby added
to read as follows:

"(ee) 'Food/dietary supplement' means a processed food product intended to supplement

the diet that bears or contains one or more of the following dietary ingredients: vitamin,
mineral, herb, or other botanical, amino acid, and dietary substance to increase the total
daily intake in amounts conforming to the latest Philippine recommended energy and
nutrient intakes or internationally agreed minimum daily requirements. It usually is in the
form of capsules, tablets, liquids, gels, powders or pills and not represented for use as a
conventional food or as the sole item of a meal or diet or replacement of drugs and
medicines.

B) Traditional Herbal Medicine

- use of plants for medicinal purposes, and the study of botany for such use. Plants have been
the basis for medical treatments through much of human history.

Republic Act No. 9502 June 6, 2008

Amending RA8293, RA6675, RA5921

AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES,

AMENDING FOR THE PURPOSE REPUBLIC ACT NO. 8293 OR THE
INTELLECTUAL PROPERTY CODE, REPUBLIC ACT NO. 6675 OR THE
GENERICS ACT OF 1988, AND REPUBLIC ACT NO. 5921 OR THE
PHARMACY LAW, AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress

assembled::

SEC. 4. Definition of Terms. - For purposes of this Act, the following terms are to mean as
follows:
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(5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk
medicine which are:

(i) recognized in the Philippine National Drug Formulary;

(ii) intended for use in the treatment or cure or mitigation of disease symptoms, injury or
body defects in humans;

(iii) other than food, intended to affect the structure or any function of the human body;

(iv) in finished or ready-to-use dosage form; and

(v) intended for use as a component of any of the articles specified in clauses (i), (ii), (iii),
and (iv);

3. Differentiate Branded from generics medicines.

Branded

-Also called innovator drugs

-Initially marketed as new chemical entities

-First version sold by the innovator manufacturer is known as the Canadian Reference
Product

Generic Drugs

-Copies of brand name drugs

-Produced after the original patent expires

Republic Act No. 6675 September 13, 1988

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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

Be it enacted by the Senate and House of Representatives of the Philippines in Congress

assembled::

Section 1. Title This Act shall be known as the "Generics Act of 1988."

Section 2. Statement of Policy It is hereby declared the policy of the State:

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; and

To promote drug safety by minimizing duplication in medications and/or use of drugs

with potentially adverse drug interactions.

Sources

Lawphil.ph

FDA website
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