Legal basis and policy rationale
- The Order is anchored on the State’s constitutional mandate that an effective food and drug regulatory system be established and maintained under 1987 Philippine Constitution (Article XIII, Section 12).
- Republic Act No. 9711 (Food and Drug Administration Act of 2009) requires the State to adopt, support, establish, institutionalize, improve, and maintain structures, processes, mechanisms, measures, and initiatives designed to protect and promote the right to health and help establish and maintain an effective health products regulatory system responsive to the country’s health needs and problems.
- The Order aligns distribution and storage standards with international good practices through the adoption of WHO GDP and WHO GSP guides.
- The Order recognizes that earlier regulatory issuances enhanced capability for proper storage and distribution but were not equivalent to international WHO standards.
Objectives of the Order
- The Order officially adopts and implements WHO Annex 5 GDP and WHO Annex 9 GSP as the governing standards for pharmaceutical distribution and storage practices.
- The Order uses WHO Annex 5 GDP and Annex 9 GSP as the standards in assessing GDP and GSP compliance of drug establishments and retailers.
- The Order provides a coordinated transition period to move from previous guidelines to the WHO GDP and GSP guides.
Coverage and entities regulated
- The Order applies to the FDA.
- The Order applies to drug establishments.
- The Order applies to retailers that sell or offer health products directly to the general public.
Definitions used in implementation
- “Authorization” means a permission embodied in a document granted by the FDA to a natural or juridical person who applies to implement manufacturing, importation, exportation, sale, offer for sale, distribution, transfer, and—where appropriate—use, testing, promotion, advertising, or sponsorship of health products; it may be a permit, license, certificate of registration, accreditation, compliance, exemption, or similar document.
- “Distributor/importer/exporter” means any establishment that imports or exports raw materials, active ingredients, and/or finished products for its own use or for wholesale distribution to other establishments or outlets; if it sells to the general public, it is considered a retailer.
- “Distributor/wholesaler” means any establishment that procures raw materials, active ingredients, and/or finished products from local establishments for local distribution on a wholesale basis.
- “Drug” means:
- (a) articles recognized in the official pharmacopoeias and formularies, including official homeopathic pharmacopoeias or any documentary supplement recognized and adopted by the FDA;
- (b) articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
- (c) articles (other than food) intended to affect the structure of any function of the body of humans or animals; or
- (d) articles intended as a component of articles under (a), (b), or (c), excluding devices and their components, parts, or accessories.
- “Drug Establishment” refers to drug manufacturers/repackers, drug importers, drug distributors, drug wholesalers, drug exporters, and entities covered by the term “establishment” under RA 9711 and its implementing rules and regulations, including facilities and installations for activities involving manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products.
- “Good Distribution Practices” (GDP) means the part of quality assurance that ensures a pharmaceutical product’s quality is maintained through adequate control throughout activities occurring during the distribution process.
- “Good Manufacturing Practice” (GMP) means the part of quality assurance that ensures medicinal products are consistently produced and controlled in accordance with quality standards appropriate for intended use and as required by applicable marketing authorization or product specifications.
- “Good Storage Practices” (GSP) means the part of quality assurance that ensures a pharmaceutical product’s quality is maintained through adequate control throughout storage.
- “Retailer” means any establishment that sells or offers to sell any health product directly to the general public.
Adoption, accessibility, and general implementation rules
- The DOH-FDA adopts the current version of WHO Annex 5 GDP and WHO Annex 9 GSP to supplement A.O. 56 s. 1989 and other related laws.
- The adopted guides must be made accessible at the FDA website.
- The FDA must use WHO GDP and GSP guides as the standard for Good Distribution and Good Storage Practices in inspections.
- The FDA must revise its forms and templates to reflect the adopted WHO GDP and GSP guides.
Inspection, transition, and capacity building
- The FDA inspects drug establishments and retailers using the WHO GDP and GSP guides as the standard for compliance.
- A 1-year transition period is granted to establishments to comply with WHO Annex 5 GDP and Annex 9 GSP, starting from the Order’s effectivity date.
- The FDA and the industry must provide trainings and workshops for effective implementation.
- The FDA may create technical working group/s to support effective implementation of the WHO GDP and GSP guides.
Penalties for violations
- Existing administrative and legal sanctions apply to any person, whether judicial or natural, who violates any provision of the Order or other regulations related to the licensing of drug establishments, including retail outlets.
- Unless later amended or superseded, the existing penalties for violation of Good Distribution and Storage Practice remain in full force and effect.
Separability and repeal
- Separability clause: If any provision is found void or unenforceable in whole or in part by a court of competent jurisdiction, that provision is deemed deleted, while the remaining provisions remain in full force and effect.
- Repealing clause: All provisions of existing administrative orders, circulars, regulations, and other issuances inconsistent with the Order are repealed or amended accordingly.