Amendment to R.A. 3720 on Food, Drugs, Devices, Cosmetics

Constitutional policy and purpose

The law iterates the State policy to protect and promote the right to health of the people and instill health consciousness under Article II, Section 15 of the 1987 Constitution.
The law iterates the constitutional command that the State shall establish and maintain an effective food and drug regulatory system and undertake appropriate health manpower development and research responsive to the country’s health needs and problems under Article XIII, Section 12 of the 1987 Constitution.
Government action through the Department of Health is directed to implement these policies through standards, safe supply measures, and enforcement strengthening.
The law directs rational drug use measures, including actions against unregistered or unsafe products and adoption of national formularies and generic labeling.

Coverage, key institutions, and standards

Government enforcement is conducted through the Department of Health and the Bureau of Food and Drugs for implementation of the Act’s regulatory purposes (Section 3).
The law expressly provides that the term “Bureau” means the Bureau of Food and Drugs (Section 10(a)).
The law strengthens policy-driven regulatory activity over foods, drugs, devices, and cosmetics, including standards and quality measures, and ensuring safe and efficacious supply (Section 3).
For enforcement and administration, the law keeps the framework of the Foods, Drugs and Devices, and Cosmetics Act while expanding definitions and prohibitions (Sections 1, 3, 5, 7, 8).

Core definitions established

The law updates the term “Drugs” to include:
- Articles recognized in the current official United States Pharmacopeia-National Formulary (USP-NF), official Homeopathic Pharmacopeia of the United States, official National Drug Formulary, or any supplement; and
- Articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; and
- Articles (other than food) intended to affect the structure or any function of the body of humans or animals; and
- Articles intended as components of the specified articles, but not devices or their components, parts or accessories (Section 10(f)).
The law defines “New drugs” using enumerated conditions for composition not generally recognized for safety, efficacy, and quality, including newly discovered active ingredients, new fixed combinations, new indications, additional modes of administration, or additional dosage/strength—and provides that “new drugs” covers, to the extent applicable, “new devices” (Section 10(1)).
The law establishes new terms:
- “Batch” means a quantity of any drug or device produced during a given cycle of manufacture (Section 10(o)).
- “Batch number” means a label designation identifying the batch and permitting production history traceability through all stages of manufacture and control (Section 10(p)).
- “Director” means Director of the Bureau of Food and Drugs (Section 10(q)).
- “Distribute” means delivery or sale for purposes of distribution in commerce, excluding manufacturers or retailers of such product (Section 10(r)).
- “Expiry or expiration date” means the label date after which the drug or device is not expected to retain claimed safety, efficacy, quality, or potency or after which it is not permissible to sell (Section 10(s)).
- “Export” means to bring out of the Philippines by sea, land, or air (Section 10(t)).
- “Import” means to bring into the Philippines by sea, land, or air (Section 10(u)).
- “Manufacture” (for drugs or devices where applicable) covers all operations including propagation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing, and labeling for storage, sale, or distribution, and excludes compounding and filling of prescriptions in drugstores and hospital pharmacies (Section 10(v)).
- “New veterinary drugs” means drugs intended for animals, including those intended for animal feeds within the contemplation of implementing rules and regulations (Section 10(w)).

Prohibited acts and expanded offenses

The law prohibits the manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of any food, drug, device, or cosmetic that is adulterated or misbranded (Section 11(a)).
The law prohibits the adulteration or misbranding of any food, drug, device, or cosmetic (Section 11(b)).
The law prohibits refusal to permit entry or inspection authorized under Section 27 or to allow samples to be collected (Section 11(c)).
The law prohibits giving a guaranty or undertaking referred to in Section 12(b) that is false, with a stated exception for reliance in good faith on a guaranty or undertaking signed by and containing the name and address of the Philippine resident from whom the person received the article in good faith (Section 11(d)).
The law prohibits forging, counterfeiting, simulating, falsely representing, or using without proper authority any mark, stamp, tag, label, or other identification device authorized or required by regulations (Section 11(e)).
The law prohibits using to one’s advantage or revealing (other than to the Secretary or authorized officials, or courts in relevant judicial proceedings) any information concerning a trade secret protected under the Act (Section 11(f)).
The law prohibits altering, mutilating, destroying, obliterating, or removing labeling (or doing any other act) while the article is held for sale, resulting in the article being adulterated or misbranded (Section 11(g)).
The law prohibits using on labeling of drugs or in drug advertising any representation or suggestion that an application is effective under Sections 21 and 21-B or that the drug complies with those sections (Section 11(h)).
The law prohibits using in labeling, advertising, or other sales promotion any reference to any report or analysis furnished under Section 26 (Section 11(i)).
The law prohibits manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device not registered with the Bureau under the Act (Section 11(j)).
The law prohibits manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device by any person without the license from the Bureau required under the Act (Section 11(k)).
The law prohibits the sale or offering for sale of any drug or device beyond its expiration or expiry date (Section 11(l)).
The law prohibits the release for sale or distribution of a batch of drugs without batch certification when required under Section 22 (Section 11(m)).

Criminal penalties and good-faith defenses

Any person who violates provisions of Section 11 is punishable upon conviction by 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, at the discretion of the court (Section 12(a)).
If the offense is committed by a juridical person, the Chairman of the Board of Directors, president, general manager, or partners and/or the persons directly responsible are penalized (Section 12(a)).
No person is subject to Section 12(a) penalties for delivery in good faith if the person delivers after selling or transferring and, on request, provides the Bureau or a duly designated officer/employee with the name and address of the person from whom the person purchased or received the article and copies of documents pertaining to the delivery (Section 12(b)(1)).
No person is subject to penalties for a violation of Section 11(a) if the person establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the Philippines from whom the person received the article in good faith (Section 12(b)(2)).
No person is subject to penalties where violation exists because the article is adulterated due to containing a color other than the permissible one under regulations, if the person establishes a guaranty or undertaking signed by and containing the name and address of the manufacturer of the color that the color is permissible under applicable regulations (Section 12(b)(3)).

Adulteration, misbranding, and prescription controls

A drug or device is deemed adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance affecting safety, efficacy, or quality; or is manufactured, prepared, or held under sanitary conditions enabling contamination or injury; or the container is composed in whole or in part of any poisonous or deleterious substance; or for coloring purposes contains a color other than a permissible one as determined by the Secretary (Section 18(a)).
A drug is deemed adulterated if it is represented as a drug name recognized in an official compendium but its strength differs or its safety, efficacy, quality, or purity falls below compendium standards; the Secretary provides tests or methods of assay when prescribed methods are insufficient, and differences are not treated as adulteration if plainly stated in labeling and approved for registration as such (Section 18(b)).
A drug or device is deemed adulterated if its strength differs or its efficacy, quality, or purity falls below what it purports to possess (where not governed by paragraph (b)) (Section 18(c)).
A drug or device is deemed adulterated if substances are mixed or substituted to reduce safety, efficacy, quality, strength, or purity (Section 18(d)).
A drug or device is deemed adulterated if manufacturing or holding methods, facilities, or controls do not conform to current good manufacturing practice, failing to assure identity, strength, quality and purity characteristics it purports to possess (Section 18(e)).
A drug or device is deemed misbranded if labeling is false or misleading in any particular (Section 19(a)).
Misbranding includes packaging without labels stating the name and place of business of the manufacturer/importer/packer/distributor and an accurate statement of quantity, with reasonable variations and exemptions for small packages established by regulations (Section 19(b)).
Misbranding includes required label words/statements not prominently placed and not conspicuous enough to be read and understood by an ordinary individual under customary purchase and use (Section 19(c)).
Misbranding includes drugs for use by man containing specified narcotic or hypnotic substances or derivatives designated as habit forming unless the label bears the name and quantity/proportion and a juxtaposed “Warning—May be habit forming” statement (Section 19(d)).
Misbranding includes drugs not designated solely by a name recognized in an official compendium unless labels bear common/usual name and ingredient listing with quantities/proportions and specified substances, with exemptions that may be established by regulations when compliance is impracticable (Section 19(e)).
Misbranding includes failure to provide adequate directions for use and adequate warnings against dangerous pathological conditions, children’s use risk, unsafe dosage/method/duration, with exemptions through regulations when requirements are not necessary for public health protection (Section 19(f)).
Misbranding includes failure to package and label drugs purporting to be compendium-recognized unless packaged/labeled as prescribed, with modified packing permitted only with the consent of the Secretary (Section 19(g)).
Misbranding includes failure to package and label precautions when the Secretary finds the drug liable to deterioration (Section 19(h)).
Misbranding includes misleading container formation, imitation of another drug, or offering under the name of another drug (Section 19(i)).
Misbranding includes when dangerous to health at dosage or frequency prescribed/recommended/suggested in labeling (Section 19(j)).
Misbranding includes antibiotic or specified antibiotic-composed drugs unless from a batch with a certificate of release issued under Section 22(a) and that certificate is in effect, subject to regulations exempting drugs or classes under Section 22(a), (b), and (c) (Section 19(k)).
The Secretary provides exemptions from labeling/packaging requirements when drugs and devices are processed/labeled/repacked in substantial quantities at establishments other than the original processing site, provided drugs are not adulterated or misbranded upon removal (Section 20(a)).
Drugs intended for use by man that are habit-forming; or are toxic/potentially harmful or not safe except under supervision of a practitioner licensed to administer; or are new drugs limited to investigational use are dispensed only upon specified prescription conditions (Section 20(b)(1)):
- Written prescription; or
- Oral prescription reduced promptly to writing and filed by the pharmacist; or
- Refilling of written or oral prescription when authorized by the prescriber in the original or by oral order reduced promptly to writing and filed by the pharmacist.
Dispensing contrary to these prescription rules is deemed an act resulting in the drug being misbranded while held for sale (Section 20(b)(1)).
A drug dispensed by filling/refilling a written prescription is exempt from specified Section 19 requirements and specified packaging requirements if it bears labeling containing the dispenser name/address, prescription serial number/date of filling, prescriber name, patient name if stated, and directions/cautionary statements from the prescription (Section 20(b)(2)).
The Secretary may remove certain drugs subject to Section 19(d) and Sections 21 and 21-B from the prescription requirements when not necessary for protection of public health (Section 20(b)(3)).
A drug subject to prescription rules is deemed misbranded if, prior to dispensing, its label fails to bear the caution statement “Caution: Foods, Drugs and Devices, and Cosmetics Law prohibits dispensing without prescription”; a drug not subject to those rules is deemed misbranded if, prior to dispensing, its label bears that caution statement (Section 20(b)(4)).

Licensing, registration, and application process

No person shall manufacture, sell, offer for sale, import, export, distribute, or transfer any drug or device unless the person secures a license to operate from the Bureau after due compliance with technical requirements under rules and regulations promulgated by the Secretary (Section 21-A).
No drug or device shall be manufactured, sold, offered for sale, imported, exported, distributed, or transferred unless registered by the manufacturer, importer, or distributor in accordance with rules and regulations promulgated by the Secretary; registration provisions incorporate applicable governing rules from Section 21(b), (d), and (e) (Section 21-B).
For registration and approval, no person may manufacture, sell, offer for sale, import, export, distribute, or transfer a drug or device unless an application filed pursuant to Section 21(b) is effective for that drug or device (Section 21(a)).
Applications must be filed with the Secretary, through the Bureau, and are made under oath, and must include (1) full reports of investigations based on clinical studies conducted in the Philippines; (2) full list of component articles; (3) full statement of composition; (4) full description of methods and facilities/controls used in manufacture; (5) samples the Secretary may require; (6) specimens of proposed labeling; and (7) other requirements prescribed by regulations to ensure safety, efficacy, and good quality (Section 21(b)).
Within one hundred and eighty days after filing, or such additional period as agreed by the Secretary and applicant, the Secretary must either approve if no denial ground applies, or give notice of opportunity for a hearing under Section 21(d) on approvability (Section 21(c)).
The Secretary issues an order disapproving the application after due notice and hearing if any enumerated grounds exist, including inadequate tests; results showing unsafe or inefficacious or doubtful therapeutic value; inadequate methods/facilities/controls to preserve identity/strength/quality/purity; insufficient information to determine safety/efficacy/quality; lack of substantial evidence of the effect claimed; or labeling that is false or misleading in any particular (Section 21(d)).
The effectiveness of an application is suspended after due notice and opportunity for hearing if the Secretary finds clinical experience/tests show unsafe or ineffective use under conditions based on which the application became effective, or if the application contains any untrue statement of a material fact; the order states the findings (Section 21(e)).
The Secretary must promulgate regulations exempting investigational-use drugs and devices by qualified experts investigating safety and effectiveness (Section 21(f)).
Registration procedure applies likewise to new veterinary drugs (Section 21(g)).
The Secretary promulgates a schedule of fees for the issuance of the certificate of product registration and the license to operate under Sections 21, 21-A, and 21-B (Section 21-C).

Antibiotic batch certification

The Secretary must provide for certification of batches of drugs composed wholly or partially of any kind of antibiotic; batch certification occurs only if the drug has characteristics of identity, strength, quality and purity as prescribed in regulations necessary to ensure adequate safety and efficacy and good quality (Section 22(a)).
Prior to the effective date of such regulations, the Secretary issues a release for any batch that, in judgment, may be released without risk as to safety and efficacy, and the release prescribes expiration date and conditions under which it ceases to be effective for that batch and portions (Section 22(a)).
For this section and Section 19(k), “antibiotic drug” means any drug intended for use by man containing any quantity of a chemical substance produced by a micro-organism with capacity to inhibit or destroy micro-organisms in dilute solution (including chemically synthesized equivalent) (Section 22(a)).
The Secretary exempts from these certification requirements whenever the requirements are not necessary to ensure safety and efficacy and good quality (Section 22(b)).
The Secretary exempts from the requirements for specified categories, including drugs stored/processed/labeled/repacked at other establishments (if comply upon removal), drugs that conform to standards and are intended to manufacture other drugs, and drugs intended for investigational use by qualified experts (Section 22(c)).

Enforcement rules, publicity, and publications

The Secretary of Health issues rules and regulations necessary to enforce the Act effectively, including provisions for banning, recalling, or withdrawing unregistered, unsafe, inefficacious, or of doubtful therapeutic value drugs and devices, adoption of an official National Drug Formulary, and use of generic names in drug labeling (Section 26(a)).
The Commissioner of Customs and the Secretary of Health jointly prescribe regulations for efficient enforcement of Section 30, based on the Director’s recommendation, and such regulations take effect as determined by the Secretary after due notice (Section 26(b)).
Hearings authorized or required by the Act are conducted by the Bureau, which submits its recommendation to the Secretary (Section 26(c)).
When the Director reports that an article secured under Section 28 is adulterated, misbranded, or not registered, the Director causes notice and grants an opportunity to be heard before the Bureau to submit evidence impeaching the correctness of the finding or charge (Section 26(d)).
When a violation comes to the Director’s knowledge requiring criminal prosecution, the Director certifies the facts to the Secretary of Justice through the Secretary of Health, with laboratory reports, Bureau findings, or documentary evidence supporting the charge (Section 26(e)).
The Secretary is authorized to call on assistance from any Department, Office, or Agency for effective implementation (Section 26(f)).
The Secretary may disseminate information on foods, drugs, devices, or cosmetics in situations involving imminent danger to health or gross deception to the consumer; dissemination does not bar collecting, reporting, and illustrating results of investigations (Section 29(a)).
The Bureau publishes a Drug Reference Manual and Drug Bulletin as reference for manufacturers, distributors, physicians, consumers, and other groups as deemed necessary, and sells the Drug Reference Manual at cost (Section 29(b)).
The Secretary is authorized to impose, after notice and hearing, administrative fines of not less than PHP 1,000 nor more than PHP 5,000 for any violation of the Act, in addition to administrative sanctions under Letter of Instructions No. 1223 (Section 29-A).

Import control, sampling, bond, refusal, destruction

The Commissioner of Customs delivers to the Bureau random samples from every incoming shipment of food, drugs, devices, and cosmetics imported or offered for import into the Philippines, with notice to the owner or consignee; the sample quantity is fixed by Secretary regulation (Section 30(a)).
If examination or other means show the article was manufactured under insanitary conditions; is forbidden or restricted from sale in the country of production/export; is adulterated, misbranded, or violates Sections 21 and 21-B, the Director informs the Commissioner and the article is refused admission, except as provided in Section 30(b) (Section 30(a)).
The Commissioner causes destruction of any refused-admission article unless the article is exported under Commissioner regulations within ninety days from notice of refusal or within additional time permitted under those regulations (Section 30(a)).
If imported articles arrive at a port of entry other than Manila, random sample collection is handled by the Regional Food and Drug Supervisor with jurisdiction and samples are forwarded to the Bureau (Section 30(a)).
Pending decision on admission, the Commissioner of Customs may authorize delivery to the owner/consignee upon execution of a good and sufficient bond providing for payment of liquidated damages in the event of default as required by Customs regulations (Section 30(b)).
If the Secretary determines an article under the refusal clause can be brought into compliance by relabeling or other action, final admission determination may be deferred; upon timely written application and execution of bond, the Secretary may authorize relabeling or other actions under regulations, including destruction or export of rejected articles/portions as specified, and all actions are under supervision of a Customs officer/employee designated by the Commissioner of Customs and a duly authorized Bureau representative (Section 30(b)).
The owner or consignee pays all expenses (including travel per diem or subsistence, salaries) connected with destruction and supervision of relabeling/other action, the amount determined by regulations, and storage/cargo/labor expenses related to refused admission; nonpayment results in those expenses constituting a lien against future importations by that owner/consignee (Section 30(c)).
A food, drug, device, or cosmetic intended for export is not deemed adulterated or misbranded if it (1) conforms with the foreign purchaser’s specifications, (2) is not in conflict with laws of the destination country, and (3) is labeled on the outside of the shipping package to show export intent; if sold or offered for sale in domestic commerce, this exemption does not apply (Section 30(d)).

Repeals, modifications, and transitory coverage

The Executive Order repeals or modifies accordingly all laws, orders, issuances, rules and regulations, or parts thereof inconsistent with its provisions (Section 24).
The Executive Order amends multiple provisions of the Foods, Drugs and Devices, and Cosmetics Act across policy, definitions, prohibitions, penalties, registration/licensing, certification, enforcement, publicity, administrative sanctions, and import procedures (Sections 1–23).
The antibiotic batch certification provisions include a prior-to-regulations release mechanism governed by the Secretary’s judgment, with an expiration date and conditions for cessation of effectiveness for the batch (Section 22(a)).
The Executive Order provides fee-scheduling authority through a separate added section on a fee schedule for product registration and license to operate (Section 21-C).