QuestionsQuestions (PRC BOARD OF ACCOUNTANCY Resolution NO. 121, S. 2005)
Executive Order No. 175 further amends Republic Act No. 3720, the Foods, Drugs, and Cosmetics Act, to strengthen the regulatory system for foods, drugs, devices, and cosmetics, particularly by expanding and clarifying the Bureau of Food and Drugs’ authority and requirements.
It expanded the title to cover not only foods and cosmetics but also the purity, safety, efficacy, and quality of drugs and devices, and to vest the Bureau of Food and Drugs with authority to administer and enforce the relevant laws.
Article II, Section 15 (right to health and health consciousness) and Article XIII, Section 12 (effective food and drug regulatory system and appropriate health manpower development and research responsive to health needs).
(a) Establish standards and quality measures for foods, drugs, devices and cosmetics; (b) ensure pure and safe supply (foods/cosmetics) and pure, safe, efficacious, good-quality drugs/devices; (c) ensure rational use of drugs/devices including banning/recalling/withdrawing non-registered or unsafe/inefficacious/doubtful products and adopting a national drug formulary and generic labeling; (d) strengthen the Bureau of Food and Drugs.
‘Drugs’ include articles recognized in official compendia (e.g., USP-NF), articles intended for diagnosis/cure/mitigation/treatment/prevention of disease in humans or animals, articles affecting structure or function (other than food), and components of those articles, excluding devices or their components/parts/accessories.
A 'new drug' includes drugs whose composition is not generally recognized by qualified experts as safe, efficacious, and of good quality for the conditions recommended in labeling; or that have become recognized through prior investigations but not used to a material extent/time under new conditions; it also covers newly discovered active ingredients, new fixed combinations, new indications, additional modes of administration, or additional dosage/strength forms.
It added definitions such as 'batch', 'batch number', 'directer', 'distribute', 'expiry or expiration date', 'export', 'import', 'manufacture' (with a proviso excluding compounding/filling prescriptions in drugstores/hospital pharmacies), and 'new veterinary drugs.' These are crucial for establishing regulatory obligations (e.g., registration, licensing), traceability (batch number), and determining violations (e.g., sale beyond expiry, release of batches).
It added prohibitions on: (j) manufacturing/importing/exporting/selling/offering for sale/distributing/transferring unregistered drugs/devices; (k) doing the same without the required license; (l) selling/offering for sale beyond the expiration date; and (m) releasing a batch for sale/distribution without batch certification when required.
Upon conviction, penalties range from imprisonment of not less than one year but not more than five years, or a fine of not less than PHP 5,000 but not more than PHP 10,000, or both. If the offense is committed by a juridical person, specific corporate persons (e.g., chairman/president/general manager/partners and persons directly responsible) are penalized.
For example, a person may avoid penalties for selling/offering/transferring if the delivery was in good faith, unless he refuses to furnish the Bureau upon request the name/address of the supplier and copies of documents. There are also guaranty/undertaking good-faith defenses under specified conditions.
It can be deemed adulterated if it consists of filthy/putrid/decomposed substances affecting safety/efficacy; if manufactured/prepared/held under sanitary conditions that may cause contamination or render it injurious to health; if its container is made of poisonous/deleterious substances; if it bears an impermissible coloring; or if methods/facilities/controls don’t conform to current good manufacturing practice ensuring identity, strength, quality, and purity.
Misbranding includes false/misleading labeling, missing required label information (manufacturer place of business, quantity, etc.), improper prominence/conspicuousness of required statements, failure to bear required habit-forming warnings, failure to designate drugs properly by common/usual names, inadequate directions/warnings for safe use, improper labeling inconsistent with official compendia, and dangerous/ misleading container or labeling, among others.
Under Section 21-A, no person may manufacture/sell/offer for sale/import/export/distribute/transfer any drug or device without first securing a license to operate from the Bureau after compliance with technical requirements. Under Section 21-B, no drug or device may be manufactured/sold/offered for sale/imported/exported/distributed/transferred unless registered by the manufacturer/importer/distributor; and the provisions on approval/denial/suspension in Section 21 apply as applicable.