Vicente B.

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 doctor’s 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,

duly established in accordance with the provisions of this Act. For more information on the NDA process. shall write prescriptions using the generic name. Paelmo Pharmacology 2FMT of whatever nature and kind or device shall be compounded. "(c) Any organization or company involved in the manufacture. marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. . bottles. is hereby amended to read as follows: "SEC. dental and veterinary practitioners. importation. dispensed. 6675. or otherwise be made available to the consuming public except through a prescription drugstore or hospital pharmacy. 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. please see "The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective. sold or resold. Who Shall Use Generic Terminology. . 38. 6.(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. Non-prescription or over-the-counter drugs may be sold in their original packages. In the case of brand name products. "(b) All medical. as well as information about how the drug behaves in the body and how it is manufactured. An NDA includes all animal and human data and analyses of the data. dispensing and administering of drugs and medicines. otherwise known as the Generics Act of 1988. repacking. Section 6 of Republic Act No. convenience stores and other retail establishments. The brand name may be included if so desired. including private practitioners. containers or in small quantities. OTHERWISE KNOWN AS THE GENERICS ACT OF 1988 SEC." CHAPTER 6 AMENDMENTS TO REPUBLIC ACT NO. 6675. not in their original containers to the consuming public through supermarkets.Vicente B. 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. 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. prescribing.

REPUBLIC ACT No. import. so that public health welfare are protected by prohibiting their production. 1972 THE DANGEROUS DRUGS ACT OF 1972 Section 1. trade. distribution. or any drug which produces a physiological action similar to amphetamine. . As used in this Act. possession or use. together with their corresponding prices so that the buyer may adequately exercise his option. barbital. 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.Vicente B. such as benzedrine or dexedrine. such as secobarbital.Drugs that aren’t prohibited to the public since its therapeutic usefulness outweighs its bad effects but still needs to be regulated . Signed: BFAD. This Act shall be known and cited as "The Dangerous Drugs Act of 1972. pentobarbital." C) Regulated drugs . phenobarbital. Definitions. such as methaqualone or any other compound producing similar physiological effects. export. of amphetamine." ARTICLE I Definition of terms Section 2. "(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. isomer or salt of an isomer. 6425 April 4. manufacture. Short Title. amobarbital and any other drug which contains a salt or a derivative of a salt of barbituric acid. and hypnotic drugs. supply." which includes self-inducing sedatives. including drugstores. any salt. Paelmo Pharmacology 2FMT "(d) Drug outlets. Within one (1) year after the approval of this Act. 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. D) Prohibited drugs -Drugs with toxicity or side-effects that outweigh their therapeutic usefulness. the term: "Regulated drug. except in amounts required for medical and cure.

or 2. This Act shall be known and cited as "The Dangerous Drugs Act of 1972. coca leaf and its derivatives. all preparations made from any of the foregoing. RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA). GIVING AUTHORITY TO RETAIN ITS INCOME. A) Food Supplements -Non food substances that are used to augment the dietary intake of minerals. 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. 1972 THE DANGEROUS DRUGS ACT OF 1972 Section 1. alpha and beta eucaine. AND APPROPRIATING FUNDS THEREOF . 6425 April 4. such as heroin and morphine." ARTICLE I Definition of terms Section 2. lysergic acid diethylamide (LSD) and other substances producing similar effects. AS AMENDED. whether natural or synthetic. principally cocaine. vitamins. AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. Definitions. As used in this Act. AUGMENTING ITS HUMAN RESOURCE COMPLEMENT. such as mescaline. 3720. amino acids etc." which includes opium and its active components and derivatives. Republic Act No. the term: (1) "Prohibited drug. UPGRADING ITS EQUIPMENT. with the physiological effects of a narcotic drug. Differentiate drug from a) food supplements and b) traditional herbal medicine. Paelmo Pharmacology 2FMT REPUBLIC ACT No. and other drugs.Vicente B. Short Title. hallucinogenic drugs. Indian hemp and its derivates. 9711 August 18.

(cc). as amended. (jj). (ff).For purposes of this Act. and new subsections (x). (f). (hh). (ee). (g). liquids. (y). subsections (a). 8293 OR THE INTELLECTUAL PROPERTY CODE. Republic Act No. (gg). amino acid. (e). REPUBLIC ACT NO. RA5921 AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES. 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. (q). Plants have been the basis for medical treatments through much of human history. (i). Definition of Terms. 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. 9502 June 6. Paelmo Pharmacology 2FMT Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:: Section 9. are hereby further amended. (ii). 2008 Amending RA8293. 5921 OR THE PHARMACY LAW. tablets. B) Traditional Herbal Medicine . and (w) of Republic Act No.Vicente B. (dd). Section 10. (ll). herb. . the following terms are to mean as follows: . (z). 6675 OR THE GENERICS ACT OF 1988. (v). 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. and the study of botany for such use. (bb). AND FOR OTHER PURPOSES Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:: SEC. (kk).(r). It usually is in the form of capsules. 4. 3720. gels. RA6675. mineral. AND REPUBLIC ACT NO. (aa). (h). or other botanical. AMENDING FOR THE PURPOSE REPUBLIC ACT NO.use of plants for medicinal purposes.

6675 September 13. 1988 . injury or body defects in humans. (ii). intended to affect the structure or any function of the human body. 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. 3. Differentiate Branded from generics medicines. and (v) intended for use as a component of any of the articles specified in clauses (i). (iii) other than food. (iii).Vicente B. and (iv). (ii) intended for use in the treatment or cure or mitigation of disease symptoms. (iv) in finished or ready-to-use dosage form. Paelmo Pharmacology 2FMT (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.

ph FDA website . Title – This Act shall be known as the "Generics Act of 1988. DISTRIBUTION. To emphasize the scientific basis for the use of drugs. Statement of Policy – It is hereby declared the policy of the State: To promote. 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. 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." Section 2. 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. REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY. marketing. prescription and dispensing of drugs.Vicente B. distribution. Paelmo Pharmacology 2FMT AN ACT TO PROMOTE. encourage and require the use of generic terminology in the importation. Sources Lawphil. advertising and promotion. manufacture. To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution.

Paelmo Pharmacology 2FMT .Vicente B.