A FRIENDLY REMINDER ON OTC DRUGS

DRUG REGULATIONS IN THE PHILIPPINES

 The regulation of food and drugs in the Republic of the Philippines is enshrined in the 1987 Philippine Constitution.  Statutory laws are also in place providing legal basis for the creation of a regulatory agency, the Bureau of Food and Drugs, mandated to ensure the safety, efficacy, and good quality of all food and drug products being made available to the general public. MANDATE

 Regulation is achieved through inspection and licensing of food and drug establishments, registration and market monitoring of products, approval of product label prior to marketing, and approval and monitoring of promotions and advertisements. REGULATIONS

 International standards which are used as a basis in the formulation and implementation of rules and regulations governing the manufacture, importation, exportation, distribution, or sale of food and drugs include:  WHO  USP or BP  FAO (Food and Agriculture Organization)  Codex Alimentarius (general standard for contaminants and toxins in food and feed) INTERNATIONAL GUIDELINES

 Compliance with the requirements of GMPs is the basis criterion for licensing food and drug establishments  Safety and efficacy are the criteria for registration of products COMPLIANCE

 Republic Act (RA) 3720 – “Foods, Drugs, Medical Devices and Cosmetics Act  An act to ensure the safety and purity of foods, drugs, and cosmetics being made available to the public by creating the food and drug administration which shall administer and enforce the laws pertaining thereto. MOST IMPORTANT LAWS

 An Act strengthening and rationalizing the regulatory capacity of the Bureau of Food and Drugs by 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 RA 3720, as amended and appropriating funds thereof. RA 9711 – FOOD AND DRUG ADMINISTRAION ACT OF 2009

 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. RA 6675 – GENERICS ACT OF 1988

 To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions RA 6675

 An act prohibiting counterfeit drugs, providing penalties for violations and appropriating funds therefor. RA 8203 – “ACT PROHIBITING COUNTERFEIT DRUGS”

 For purposes of this Act, Drugs shall refer to... any article recognized in the Official United States Pharmacopoeia – National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippine National Drug Formulary, British Pharmacopoeia, any National Compendium or any supplement to any of them. RA 8203

 An act instituting the comprehensive dangerous drugs act of 2002, repealing RA 6425, otherwise known as the Dangerous Drugs Act of 1972, as amended, and providing funds for its implementation. RA 9165 – COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002

 Under this Act, the Dangerous Drugs Board (DDB) remains as the policy- making and strategy-formulating body in planning and formulation of policies and programs on drug prevention and control.  It also created the Philippine Drug Enforcement Agency (PDEA) under the Office of the President..... RA 9165

 This Act shall be known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008”.  An Act providing for cheaper and quality medicines RA 9502

 The policy of the State aims at protecting the interests of the consumer, promote his general welfare and to establish standards of conduct for business and industry.  Is designed to prevent business that engage in fraud or specified unfair practices from gaining an advantage over competitors and provide additional protection for the weak and those unable to take care of themselves. RA 7394 – “CONSUMERS ACT”

 Defines food as any substance or product whether processed, partially processed or unprocessed that is intended for human consumption.  Includes drinks, chewing gums, water and other substances which are intentionally incorporated into the food during its manufacture, preparation and treatment.  This law primarily aims to strengthen the food safety regulatory system in the country. RA – FOOD SAFETY ACT OF 2013

 Works in the principles of achieving food safety  Food safety regulatory system is a combination of:  Regulations, food safety standards, inspection, testing, data collection, monitoring, and other activities carried out by food safety regulatory agencies and LGUs. RA 10611