Drug Labeling Requirements of the Food and Drug Administration

Governing Regulation for Drug Labelling Requirements

The primary sources of information for consumers are the labels and labeling materials, as they provide useful information such as those dealing with the safe and effective use of a drug product (e.g. indication(s), pharmacologic class and dosage), and information dealing with quality (e.g. manufacturing and expiration dates, registration number, and manufacturer).

To ensure that drug establishments provide the most accurate information relating to their products, the Food and Drug Administration (FDA) issued Administrative Order No. 2016- 0008, otherwise known as the Rules and Regulations Governing the Generic Labeling Requirements of Drug Products for Human Use (“FDA Regulations”). The Rules promulgated by the FDA aims to rationalize the existing rules and regulations on generic labeling requirements of drug products.

How does the FDA define the term ‘drug’?

The FDA Regulations define the term Drug Product or ‘Drug’ as follows:

1. any article recognized in the official United States Pharmacopoeia National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States (FIPUS), Philippine Pharmacopoeia (PP), Philippine National Drug Formulary pNDF), British Pharmacopoeia (BP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), International Pharmacopoeia (Ph. Int), any national compendium or any supplement to any of them;

• any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals;

• any article other than food intended to affect the structure or any function of the human body or animals;

• any article intended for use as a component of any article specified in clauses (a), (b) and (c) not including devices or their components, parts or accessories;

• herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine which are:

1. recognized in the Philippine National Drug Formulary
2. intended for use in the treatment, cure or mitigation of disease symptoms, injury or body defects in humans
3. other than food, intended to affect the structure or any function of the human body
4. in finished or ready-to-use dosage form; and
5. intended for use as a component of any of the articles specified in clauses i, ii, iii and iv.

What is a Label?

A label means the written, printed or graphic matter on any drug product, its immediate container, tag, literature or other suitable material affixed thereto. The label on the drug product is important because it gives information as to the identity, components, ingredients, attributes, directions for use, specifications and such other information as may be required by law or regulation.

Who are mandated to comply with the drug labeling requirements?

For purposes of coverage of the FDA Regulations, a manufacturer refers to an establishment involved in the production of health products, as well as the final release of the finished product, with the end view of its storage, sale or distribution to the public. Drugstores and hospitals compounding and filling prescriptions are obviously excluded from this term.

Under the FDA Regulations, the FDA mandated all manufacturers and distributors (i.e. exporters, importers, and wholesalers) of drug products for human use, including herbal medicines and traditionally-used herbal products, to comply with its labelling requirements.

What minimum mandatory information should appear in the labeling materials accompanying a drug product?

Usually, drug products contain various packaging labels, including the labels found on the immediate container, the packaging box or outer wrapper carton, and the other printed materials that are made available with the drug product at the time of purchase and/or when the product is used such as the package insert or leaflet that usually accompanies medicines and drug product, and which provide the accurate and necessary detailed information for the identification and proper use of the product.

The FDA Regulations require the following information to appear in the drug labelling materials accompanying all drug products:

1. Product Name
2. Dosage Form and Strength
3. Pharmacologic Category
4. Formulation/Composition
5. Indication(s)
6. Dosage and Mode of Administration
7. Contraindication(s), Precaution(s), Warning(s) (if applicable)
8. Interactions
9. Adverse Drug Reaction(s)
10. Overdose and Treatment
11. Storage Condition(s)
12. Net Content or Pack Size
13. Name and Address of MAH
14. Name and Address of Manufacturer
15. For prescription drug products, Rx Symbol and Caution Statement
16. ADR Reporting Statement
17. Registration Number
18. Batch Number and Lot Number (if any)
19. Expiration Date and Date of Manufacture

The FDA also requires that the mandatory information in drug labels be written in English and/or Filipino and readable with normal vision without straining. In requiring these mandatory information to appear, the purpose of the FDA is to ensure that the information is readable and discernable to the consumers. For this reason, the FDA also provided specifications in terms of the label design’s color contrast, position and spacing of the printed matter on the label, requiring these elements to be taken into consideration in complying with the information that must appear on the labels.

For all New Chemical Entity (NCEs), biological products, and prescription generic products and herbal medicines, the FDA requires the submission of a Package Insert (PI). On the other hand, for all household remedies, over-the-counter drug and herbal medicines, and traditionally-used herbal products, the FDA requires the submission of a Patient Information Leaflet (PIL).

As defined by the FDA regulations, the Package Insert is the document defining information that is supplied with prescription drug products by the Marketing Authorization Holder (MAH). The PI is intended for use by healthcare professionals. On the other hand, a Patient Information Leaflet (PIL) is the document defining information that is supplied with non-prescription drug products by the MAH. The PIL is intended for use by patients and is written in layman’s language.

In lieu of the PI or PIL, the manufacturer or distributor may print the information required to appear in the PI or PIL on the reverse side or inner panel of the outer packaging material or inner carton, provided that when the product is sold or dispensed, the packaging or inner carton should be provided together with the drug product. 

For products intended to be sold without any product information sheet and box outer carton, the minimum mandatory information enumerated above must be clearly reflected on the primary label.

For purposes of ensuring compliance with the FDA Regulations, the FDA requires manufacturers and distributors to submit revised labeling materials upon renewal of their respective Marketing Authorizations (MA) covering the registered drug product.  

How should the generic name be indicated in a drug product?

Republic Act No. 6675, or otherwise known as the Generics Act of 1988, provides that any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. 

In the case of brand name products, the FDA requires the generic name to appear prominently and immediately above the brand name in all product labels, as well as in advertising and other promotional materials.

What is the effect of dispensing drugs without prescription?

Section 20 of Republic Act No. 3720 provides that drugs intended for human use which are a) habit-forming; b) because of its toxicity or other potentiality for harmful effect, or the method of its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or c) are new drugs whose application are limited to investigational use, should only be dispensed according to the law.

Thus, these classes of drug products must be dispensed only:

(1) upon a written prescription of a practitioner licensed by law to administer such drug;

(2) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or

(3) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

The act of dispensing a drug in violation of these requirements is considered, under FDA Regulations, to be an act which results in the drug being misbranded while held for sale. The FDA Regulations impose administrative and penal sanctions on the act of misbranding.

In addition, a drug shall also be considered as “misbranded” if at any time prior to dispensing the drug, its label fails to bear the statement “Caution: Food, Drug and Cosmetics Law prohibits dispensing without prescription.”

The use and appearance of this “Caution” statement is likewise strictly regulated, and should appear only in drugs and drug products that may only be dispensed with prescription. This is because the FDA will likewise consider a drug or drug product as misbranded if the drug or drug product can be dispensed without a prescription, and the “Caution” statement is found in any of its labels.

What if the drug establishment does not comply?

Any violation of the FDA Regulations shall be a ground for the filing of appropriate administrative charges and/or imposition of administrative sanctions, including the imposition of fines, suspension, cancellation or revocation of any license, permit or registration issued by FDA.

About Nicolas and De Vega Law Offices

If you need assistance in Drug Labeling or other FDA-related issues, we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines.  You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines.  You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at info@ndvlaw.com. Visit our website www.ndvlaw.com.