Amendments to R.A. No. 3720 on Food, Drugs and Cosmetics

Constitutional policy and program direction

Executive Order No. 175 iterates Article II, Section 15 of the 1987 Constitution, declaring State policy to protect and promote the right to health of the people and instill health consciousness.
Executive Order No. 175 iterates Article XIII, Section 12 of the 1987 Constitution, directing the State to establish and maintain an effective food and drug regulatory system and to undertake appropriate health manpower development and research responsive to the country’s health needs and problems.
The government, through the Department of Health, must implement these policies under Republic Act No. 3720 as amended.

Revised statute titles and chapter heads

Section 1 amends the title of Republic Act No. 3720 to:
“An Act to Ensure The Safety And Purity of Foods and Cosmetics, And The Purity, Safety, Efficacy and Quality of Drugs and Devices Being Made Available to the Public, Vesting The Bureau of Food and Drugs with Authority To Administer And Enforce the Laws Pertaining Thereto, And For Other Purposes”
Section 2 amends Section 1 of Republic Act No. 3720 to provide that the Act shall be known as the “Foods, Drugs and Devices, and Cosmetics Act.”
Section 3 amends the headnote of Chapter II and updates Section 2 to iterate the constitutional policy statements.
Section 16 amends the title of Chapter IX to “Certification of Drugs Containing Antibiotics.”
Section 18 amends the headnote before Chapter XI to “General Administration Provisions, Administrative Sanctions, Regulations, Hearing and Institution of Criminal Action.”
Section 20 amends the headnote before Section 29 to “PUBLICITY AND PUBLICATION.”

Government duties for standards, drugs use, enforcement

In implementing the policies, the Department of Health must:
- (a) establish standards and quality measures for foods, drugs, devices, and cosmetics;
- (b) adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious and good quality drugs and devices;
- (c) adopt measures to ensure the rational use of drugs and devices, including banning, recalling or withdrawing from the market drugs and devices that are not registered, unsafe, inefficacious, or of doubtful therapeutic value, adoption of an official National Drug Formulary, and use of generic names in drug labeling; and
- (d) strengthen the Bureau of Food and Drugs.
The Secretary of Health must issue rules and regulations necessary to enforce Republic Act No. 3720 (including the market actions and formulary/generic-names measures identified above).
Hearings authorized or required by the Act must be conducted by the Bureau, which submits its recommendation to the Secretary.
The Secretary is authorized to request the assistance of any Department, Office, or Agency for effective implementation.

Key definitions and operational terms added/amended

Section 5 amends Section 10(a) of Republic Act No. 3720 by defining:
- “Bureau” as the Bureau of Food and Drugs; and
- “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 to any of them;
  - articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
  - articles (other than food) intended to affect the structure or any function of the body of man or animals; and
  - articles intended for use as a component of articles specified above, excluding devices or their components, parts or accessories.
“New drugs” are defined to include, among others:
- drugs whose composition is not generally recognized among qualified experts as to safety, efficacy, and quality under labeled conditions;
- drugs newly recognized based on prior investigations but not otherwise used to a material extent or time under new conditions;
- drugs containing a newly discovered active ingredient; new fixed combinations; new indications; additional new mode(s) of administration; or additional dosage or strength that meet the “new drug” conditions.
Section 6 adds the following definitions under Section 10 of Republic Act No. 3720:
- “Batch”: a quantity of any drug or device produced during a given cycle of manufacture.
- “Batch number”: a label designation identifying the batch and permitting tracing/review of all stages of manufacture and control.
- “Director”: Director of the Bureau of Food and Drugs.
- “Distribute”: delivery or sale for distribution in commerce, excluding the manufacturer or retailer.
- “Expiry or expiration date”: the labeled date after which the drug or device is not expected to retain claimed safety, efficacy and quality or potency, or after which it is not permissible to sell.
- “Export”: bringing out of the Philippines by sea, land, or air.
- “Import”: bringing into the Philippines by sea, land, or air.
- “Manufacture” (for drugs/devices): operations involved in production, including propagation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing, and labeling for storage, sale, or distribution; it does not apply to compounding and filling of prescriptions in drugstores and hospital pharmacies.
- “New veterinary drugs”: drugs intended for animals, including drugs intended for animal feeds under implementing rules and regulations’ contemplation.
Section 5 further states that the definition of “new drugs” covers, to the extent applicable, “new devices.”

Prohibited acts and added drug/device violations

Section 7 amends Section 11 of Republic Act No. 3720 by prohibiting:
- manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of any adulterated or misbranded food, drug, device, or cosmetic;
- adulteration or misbranding itself;
- refusal to permit entry or inspection authorized under Section twenty-seven or refusal to allow samples collection;
- giving a false guaranty/undertaking referenced in Section twelve (b), with an exception for good-faith reliance on a guaranty/undertaking signed by and identifying the person residing in the Philippines from whom the article was received in good faith;
- forgery/counterfeiting/simulation/falsely representing, or using without proper authority any mark/stamp/tag/label/identification device authorized or required by regulations;
- using any trade secret information for personal advantage or revealing it other than to the Secretary or Department officers/employees or to the courts in relevant proceedings;
- altering, mutilating, destroying, obliterating, or removing labeling (or doing any other act) while the article is held for sale that results in the article being adulterated or misbranded;
- labeling/advertising claims that a drug application is effective under Sections twenty-one and twenty-one-B or that the drug complies with those sections;
- using labeling/advertising/other sales promotion references to any report or analysis furnished in compliance with Section twenty-six.
Section 8 adds further prohibitions under Section 11:
- (j) manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device not registered with the Bureau pursuant to the Act;
- (k) doing any of the same actions without the license from the Bureau required under the Act;
- (l) selling or offering for sale any drug or device beyond its expiration or expiry date;
- (m) releasing for sale or distribution a batch of drugs without batch certification when required under Section twenty-two.

Criminal penalties and evidentiary safeguards

Section 9 amends Section 12 of Republic Act No. 3720:
- A person convicted of violating Section 11 is punishable 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, in the court’s discretion.
- If the offense is committed by a juridical person, the Chairman of the Board of Directors, president, general manager, or the partners and/or persons directly responsible are penalized.
Section 12(A)(b) provides conditions when certain sellers/distributors are not subject to penalties:
- a person is not subject to penalties for selling/offering for sale/transferring and delivering an article in good faith, unless the person refuses to furnish on request of the Bureau or a duly designated officer/employee: (1) the name and address of the person from whom the article was purchased or received, and (2) copies of all documents, if any, concerning delivery;
- a person is not subject to penalties for violating Section 11(a) if the person established a guaranty/undertaking signed by, and containing the name and address of, the person residing in the Philippines from whom the article was received in good faith;
- a person is not subject to penalties for violations where adulteration exists because of a color other than the permissible one under regulations, if the person establishes a guaranty/undertaking signed by, and containing the manufacturer’s name and address, that the color is permissible under applicable regulations.

Adulteration and misbranding standards

A drug or device is deemed adulterated if, among other grounds:
- it consists in whole or in part of a filthy, putrid, or decomposed substance affecting safety, efficacy, or good quality;
- it is manufactured/prepared/held under sanitary conditions that may have contaminated it with dirt/filth or rendered it injurious to health;
- its container is composed, in whole or in part, of any poisonous or deleterious substance that may render contents injurious;
- for coloring purposes, it bears/contains any color other than a permissible one determined by the Secretary;
- it purports to be a recognized drug name in an official compendium but has strength or safety/efficacy/quality/purity below compendium standards (with procedures for assay methods set by the Secretary when existing methods are deemed insufficient, and an exception where differences are plainly stated in labeling and approved for registration);
- it is not subject to paragraph (b) and its strength differs or efficacy/quality/purity falls below what it purports or is represented to possess;
- substances were mixed/packed or substituted wholly/partly to reduce safety/efficacy/quality/strength/purity;
- methods/facilities/controls do not conform to or are not operated in conformity with current good manufacturing practice assuring identity, strength, quality, purity characteristics, and the safety/quality/efficacy claims in labeling.
A drug or device is deemed misbranded if, among other grounds:
- labeling is false or misleading in any particular;
- it is in package form unless it bears a label with: (1) the name and place of business of manufacturer/importer/packer/distributor; and (2) accurate quantity statement in weight/measure/numerical count, with reasonable variations and exemptions for small packages to be established by Secretary regulations;
- required label information is not prominently placed and conspicuously written/readable as to be likely understood by the ordinary individual under customary conditions;
- it contains specified narcotic/hypnotic substances in noncompliant labeling, unless labeling states the name and quantity/proportion and the juxtaposed “Warning—May be habit forming”;
- it is a drug not designated solely by a name recognized in an official compendium unless labeling bears the common/usual name (if any) and, if made from multiple ingredients, labels each active ingredient common/usual name and quantity/proportion, and includes names and quantities/proportions of listed substances and derivatives (with exemptions by Secretary regulations upon Director recommendation when compliance is impracticable);
- it lacks adequate directions for use and adequate warnings against dangerous pathological conditions, children-related dangers, unsafe dosage/methods/duration, in the manner and form necessary to protect users (with exemptions where not necessary for protection, via Secretary regulations);
- it purports to be a drug whose name is recognized in an official compendium unless packaged and labeled as prescribed therein (with packing modifications subject to Secretary consent);
- the Secretary finds the drug liable to deterioration unless packaged appropriately and labeled with precaution statements required by regulations;
- its container is misleading, or it is an imitation of another drug, or offered for sale under the name of another drug;
- it is dangerous to health when used at dosage/frequency/duration prescribed/recommended/suggested in labeling;
- it is composed wholly or partly of specified antibiotic classes (penicillin, cephalosporins, aminoglycosides, tetracycline, chloramphenicol, erythromycin, or other antibiotic drugs/derivatives) unless (1) it is from a batch with a certificate of release under Section twenty-two(a) and (2) the certificate of release is in effect for such drug (with exemptions provided by regulations).

Licensing, registration, and product application process

No person may manufacture, sell, offer for sale, import, export, distribute, or transfer any drug or device unless an application filed under Section 21(b) is effective with respect to the drug or device (Section 21(a)).
Application filing:
- Persons file with the Secretary, thru the Bureau, under oath, and submit full reports of investigations showing safety, efficacy, and good quality for use based on clinical studies conducted in the Philippines.
- The application must include a full list of components, full statement of composition, full description of manufacturing methods and facilities/controls, samples the Secretary requires, proposed labeling specimens, and other requirements prescribed by regulations to ensure safety, efficacy, and good quality (Section 21(b)).
Decision timeline and hearing right:
- Within one hundred and eighty days after filing (or such additional period agreed upon by the Secretary and applicant), the Secretary must either: (1) approve if no denial grounds apply, or (2) issue notice of opportunity for a hearing under Section 21(d) on approvability (Section 21(c)).
Grounds for disapproval (Section 21(d)):
- inadequate tests/methods reasonably applicable to show safety/efficacy/good quality under labeled conditions;
- tests show the drug/device is unsafe, inefficacious, or of doubtful therapeutic value, or do not show safety/efficacy/good quality;
- manufacturing methods/facilities/controls are inadequate to preserve identity, strength, quality, and purity;
- insufficient information based on application or other information before the Secretary;
- lack of substantial evidence the product will have the effect it purports/represents under labeled conditions;
- labeling is false or misleading in any particular based on evaluation of material facts.
Suspension of effectiveness:
- After due notice and opportunity for hearing, effectiveness may be suspended by Secretary order if clinical experience/tests by new or not reasonably applicable methods show the drug/device is unsafe or ineffective under the conditions of use, or if the application contains an untrue statement of a material fact; the order must state findings (Section 21(e)).
Exemptions for investigational use:
- The Secretary must promulgate regulations exempting from Section 21 drugs/devices intended solely for investigational use by experts qualified by scientific training and experience to investigate safety and effectiveness (Section 21(f)).
- The procedure applies likewise to new veterinary drugs (Section 21(g)).
License to operate (new Sections 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 due compliance with technical requirements under Secretary-issued rules and regulations (Section 21-A).
Product registration (new Sections 21-B):
- No drug or device may be manufactured, sold, offered for sale, imported, exported, distributed, or transferred unless registered by the manufacturer, importer, or distributor in accordance with Secretary rules and regulations; Section 21(b), (d), and (e) govern registration to the extent applicable (Section 21-B).
Fees (new Section 21-C):
- The Secretary must promulgate a schedule of fees for issuance of the certificate of product registration and the license to operate under Sections 21, 21-A, and 21-B.

Antibiotics batch certification and exemptions

Section 22(a) requires batch certification for drugs composed wholly or partially of any kind of antibiotic:
- The Secretary provides for certification of batches that meet characteristics of identity, strength, quality, and purity as the Secretary prescribes to ensure adequately safety/efficacy and good quality, but without certification otherwise.
- Prior to the effective date of the regulations implementing this section, the Secretary must issue a release for any batch that may be released without risk as to safety/efficacy, and that release must prescribe the expiration date and other conditions under which it ceases to be effective as to the batch and portions thereof.
- The term “antibiotic drug” means any drug intended for use by man containing any quantity of any chemical substance produced by a micro-organism that inhibits or destroys micro-organisms in dilute solution (including chemically synthesized equivalents).
Exemptions from batch certification and from misbranding-related requirements linked to antibiotic drugs:
- If in the Secretary’s judgment requirements of Section 22 and Section 19(k) are not necessary for safety and efficacy and good quality, the Secretary must promulgate regulations exempting the drug or class from such requirements (Section 22(b)).
Exemptions for certain establishment uses and investigational drugs (Section 22(c)):
- drugs stored/processed/labeled/repacked at establishments other than where manufactured are exempt from the requirements if they comply upon removal;
- drugs conforming to applicable identity/strength/quality/purity standards prescribed by the regulations and intended for manufacturing other drugs are exempt;
- drugs intended for investigational use by qualified experts are exempt.

Administrative fines and labeling/publication powers

In addition to administrative sanctions provided for under Letter of Instructions No. 1223, the Secretary is authorized to impose, after notice and hearing, administrative fines of not less than PHP 1,000 and not more than PHP 5,000 for any violation of Republic Act No. 3720 as amended (Section 29-A).
The Secretary may disseminate information regarding foods, drugs, devices, or cosmetics in situations involving, in the Secretary’s opinion, imminent danger to health or gross deception to the consumer; collecting, reporting, and illustrating results of investigations is allowed.
The Bureau must publish a Drug Reference Manual and Drug Bulletin as reference for manufacturers, distributors, physicians, consumers, and other groups as deemed necessary.
The Bureau is authorized to sell the Drug Reference Manual at cost.

Import controls: sampling, refusal, bonds, destruction

Random sampling for imported goods:
- The Commissioner of Customs must deliver to the Bureau samples taken at random from every incoming shipment of foods, drugs, devices, and cosmetics imported or offered for import into the Philippines, with notice to the owner or consignee.
- The sample quantity must be fixed by regulations issued by the Secretary.
Grounds for refusal admission and destruction/execution of refusal:
- If examination or otherwise shows the article was manufactured under insanitary conditions, or is forbidden/restricted from sale in the country of production/export, or is adulterated/misbranded or violates Sections 21 and 21-B, the Director must inform the Commissioner and the article is refused admission (except subsection (b) conditions).
- The Commissioner must cause destruction of refused articles unless the article is exported under regulations within ninety days of the notice of refusal or within additional time permitted under the regulations (Section 30(a)).
- If the imported shipment arrives at a port other than Manila, sampling is handled by the Regional Food and Drug Supervisor with jurisdiction and samples must be forwarded to the Bureau (Section 30(a)).
Bond and possible relabeling/deferred determination:
- Pending decision on admission, the Commissioner may authorize delivery to owner/consignee upon execution of a good and sufficient bond for liquidated damages in default, as required by Commissioner regulations (Section 30(b)).
- If the Secretary determines that an article within Section 30(a)(3) may be brought into compliance by relabeling or other action, the Secretary may defer final determination and, upon timely written application and execution of the bond, authorize relabeling/other actions specified in the authorization under regulations.
- Authorized relabeling/other actions must be supervised by a designated officer/employee of the Bureau of Customs and a duly authorized Bureau representative.
Costs and lien for nonpayment:
- Expenses for destruction and supervision of authorized relabeling/other actions, as well as storage/cargo/labor expenses for refused admission, must be paid by the owner/consignee.
- Failure to pay constitutes a lien against any future importations by the owner/consignee (Section 30(c)).
Export labeling carve-out:
- A food/drug/device/cosmetic intended for export is not deemed adulterated or misbranded if it (1) conforms to specification of the foreign purchaser, (2) is not in conflict with laws of the country of intended export, and (3) is labeled on the outside of the shipping package to show it is intended for export.
- If sold or offered for sale in domestic commerce, this carve-out does not exempt it from provisions of the Act (Section 30(d)).

Implementing rules and administration coordination

The Secretary, upon recommendation of the Director, must issue regulations enforcing the Act, including regulations providing for banning/recalling/withdrawing unregistered or unsafe or ineffective drugs/devices, National Drug Formulary adoption, and generic labeling.
The Commissioner of Customs and the Secretary of Health must jointly prescribe regulations for efficient enforcement of Section thirty, based on the Director’s recommendation, and these regulations take effect at such time after due notice as the Secretary of Health determines.
Where the Director finds an article secured under Section twenty-eight is adulterated, misbranded, or not registered, the Director must cause notice and give an opportunity to be heard before the Bureau to submit evidence impeaching the correctness of findings/charges (Section 26(d)).
When a violation comes to the Director’s knowledge such that criminal prosecution should be instituted, the Director certifies the facts to the Secretary of Justice through the Secretary of Health, including the laboratory report, Bureau findings, or documentary evidence (Section 26(e)).

Repeal, modification, and final effect

Section 24 repeals or modifies inconsistent laws, orders, issuances, rules, and regulations, or parts thereof, to the extent of inconsistency with Executive Order No. 175.
Section 25 sets effectivity at fifteen days after publication in the Official Gazette.