QuestionsQuestions (EXECUTIVE ORDER NO. 175)
EO 175 further amends RA 3720 to strengthen the Philippine food, drugs, devices, and cosmetics regulatory system by adjusting definitions, prohibitions, licensing/registration requirements, batch certification for antibiotic drugs, labeling/dispensing rules, administrative sanctions, and related enforcement provisions through the Bureau of Food and Drugs and the Department of Health.
It expands the title to cover foods, cosmetics, and the purity, safety, efficacy, and quality of drugs and devices, and expressly vests authority in the Bureau of Food and Drugs to administer and enforce the laws.
They reiterate constitutional policies protecting the right to health, instilling health consciousness, and establishing an effective food and drug regulatory system responsive to health needs and problems.
Among others: establishing standards and quality measures; ensuring pure and safe supply (including cosmetics) and pure/safe/efficacious/good quality drugs and devices; adopting measures for rational use of drugs (including banning/recalling/withdrawing unregistered or unsafe/inefficacious drugs, adopting a Drug Formulary, and using generic names in labeling); and strengthening the Bureau of Food and Drugs.
It defines drugs as: (1) articles recognized in official compendia such as USP-NF, Homeopathic Pharmacopeia of the US, National Drug Formulary, or supplements; (2) articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease; (3) articles (other than food) intended to affect body structure/function; and (4) components of articles specified above, excluding devices or their components/parts/accessories.
A drug not generally recognized among qualified experts as safe, efficacious, and of good quality under prescribed conditions; or a drug recognized based on prior investigations but not used to a material extent/time under new conditions; including drugs with newly discovered active ingredients, new fixed combinations, new indications, new modes of administration, or additional dosages/strengths meeting the conditions.
EO 175 adds definitions such as: (1) “Batch” and “Batch number” (for traceability and manufacturing history); (2) “Expiry/expiration date” (for sale eligibility); (3) “Directora” (Director of the Bureau of Food and Drugs); (4) “Manufacture” (includes many production operations but excludes compounding/filling of prescriptions in drugstores/hospital pharmacies). These definitions support enforcement of registration, batch certification, and prohibitions.
They prohibit, among others: manufacturing/importing/exporting/selling/offering for sale/distributing/transfer of adulterated or misbranded foods/drugs/devices/cosmetics; refusal to permit entry or inspection and sample collection; false guaranties/undertakings; tampering with labeling; misleading labeling/advertising claims; and newly added acts involving: unregistered drugs/devices, drugs/devices sold without required license, selling beyond expiry date, and release for sale of batches without batch certification when required.
Upon conviction: imprisonment of not less than one year nor more than five years, or a fine of not less than PHP 5,000 but not more than PHP 10,000, or both—subject to the Court’s discretion. EO 175 also provides that if committed by a juridical person, specified corporate officers and persons directly responsible may be penalized.
No penalty for a person who in good faith sold/offered/transferred if he can, upon request, furnish the Bureau/officer/employee with the name/address of the supplier and copies of documents pertaining to delivery; or for certain guaranty-based defenses if the guaranty is signed and contains specified identifying information of the Philippine-based person from whom it was received; and for adulteration due to color only, if the person establishes a guaranty that the color is permissible under applicable regulations and identifies the manufacturer of the color.
For example: if it consists of filthy/putrid/decomposed substance affecting safety/efficacy/good quality; if manufactured/prepared/held under sanitary conditions that may contaminate it or render it injurious; if container materials are poisonous/deleterious; if for coloring it bears an impermissible color; if strength/safety/efficacy/quality/purity fall below official compendium standards; if substituted/mixed to reduce safety/efficacy/quality/strength/purity; or if manufacturing/holding methods/facilities/controls do not conform to current good manufacturing practice to assure identity/strength/quality/purity.
It enumerates misbranding situations such as false/misleading labeling; incomplete or incorrect label information on packages; labeling not prominently placed or not understandable to ordinary consumers; missing required warnings (including habit-forming warnings when applicable); lack of adequate directions and warnings; packaging/labeling inconsistent with official compendia; improper labeling for dangerous-to-health dosage/frequency; and additional requirements for antibiotic drugs (e.g., must be from a batch with a certificate of release under Section 22(k) in effect unless exempt).
Drugs intended for use by man that are habit-forming; or toxic/harmful except under supervision; or new drugs limited to investigational use must be dispensed only upon a written prescription (or oral prescription promptly reduced to writing and filed by pharmacist), with rules on refilling if authorized by the prescriber. Dispensing contrary to the requirements makes the drug misbranded while held for sale. There are also label exceptions for dispensed prescription drugs (e.g., exemption from some labeling requirements if the dispenser’s label includes required prescription/dispenser details).
Section 21-A: no person may manufacture, sell, offer for sale, import, export, distribute, or transfer any drug or device without first securing a license to operate from the Bureau after compliance with technical requirements. Section 21-B: no drug or device may be manufactured, sold, offered for sale, imported, exported, distributed, or transferred unless registered by the manufacturer/importer/distributor, governed by rules under RA 3720.
It requires the Secretary to provide for certification of batches of drugs composed wholly or partially of antibiotics. A batch is certified only if it has required characteristics of identity, strength, quality, and purity. Prior to the effective date of regulations, the Secretary may issue a release for any batch judged safe without risk, prescribing expiration date and conditions. It also allows regulations to exempt certain drugs/classes where certification is not necessary, and exemptions for drugs stored/processed/labeled/repacked in other establishments as long as they comply upon removal, for drugs conforming to standards for manufacturing other drugs, and for drugs intended for investigational use.
Section 29-A authorizes the Secretary, after notice and hearing, to impose administrative fines of PHP 1,000 to PHP 5,000 for any violation in addition to administrative sanctions under LOI No. 1223. Section 26 updates regulatory/enforcement authority (including rules on banning/recalling/withdrawing unregistered or unsafe/inefficacious drugs and devices), hearing procedures (conducted by the Bureau with recommendation to the Secretary), and directives on criminal prosecution certification to the Secretary of Justice via the Secretary of Health.