section name header

Information

Section 502 of the FDCA, in part, provides that a drug or device shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular. Healthcare economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved ... for such drug and is based on competent and reliable scientific evidence. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term "health care economic information" means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.

(b) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count....

(c) If any word, statement, or other information required is not prominently placed on the label, with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(e)(1)(A) If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula) (i) the established name (as defined in subparagraph (3)) of the drug, if there is such a name; (ii) the established name and quantity or, if determined to be appropriate by the Secretary, the proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not the established name and quantity or if determined to be appropriate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein, except that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subclause, shall not apply to nonprescription drugs not intended for human use; and (iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use.

(3) As used in paragraph (1) the term "established name" means (A) the applicable official name, or (B) if there is no such name and the drug is an article recognized in an official compendium, then the official title in the compendium or (C) if neither clause (A) nor clause (B) of this paragraph applies, then the common or usual name.

(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement.

(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein.

(h) If it has been found to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions.

(i)(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.

(j) If it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling, thereof.

(m) If it is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with applicable packaging and labeling requirements.

(n) Unless the manufacturer, packer or distributor includes in all advertisements and other descriptive printed matter a true statement of (1) the established name printed prominently and in type at least half as large as that used for any trade or brand name, (2) the formula showing quantitatively each ingredient of the drug and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness.

(p) If it is a drug and its packaging or labeling is in violation of an applicable regulation of the Poison Prevention Packaging Act of 1970 (§ 502; 21 U.S.C. § 352).

As noted previously, failure to manufacture certain OTC products in a tamper-evident package is also misbranding.

Explanation of Misbranding

Nonprescription Drug Labeling

Prescription Drug Labels and Labeling

National Drug Code Number

Take-Away Points

Study Scenarios and Questions

  1. A pharmacist received a prescription for a brand name drug and substituted a generic drug pursuant to state law. The pharmacist labeled the dispensed generic drug using the brand name drug name. Explain whether the pharmacist has violated the FDCA.

  2. A pharmacist received a call from a physician who ordered ibuprofen 600 mg for a patient but instructed the pharmacist to label the drug as oxycodone. Explain whether the pharmacist would violate the FDCA if he or she complies and whether this situation differs from the situation in Question 1.

  3. A patient hands a pharmacist a prescription for Spondicin 20 mg (fictitious), a prescription-only drug. As the patient is waiting for the prescription to be filled, the patient notices that Spondicin 10 mg is available OTC and asks the pharmacist how it can be that one strength is prescription only and the other is OTC. What should the pharmacist say? Would the pharmacist violate the FDCA by telling the patient to use the OTC drug for the prescribed indication in the prescribed dose when that indication or dosage is not contained in the OTC drug's labeling?