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MS MPJE: Federal Food, Drug, and Cosmetic Act: FDA Approval, Labeling, and Marketing

MS MPJE · Work through your exam, one topic at a time.

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Federal Food, Drug, and Cosmetic Act: FDA Approval, Labeling, and Marketing

The federal frame

The FDCA treats a drug as a "new drug" unless it is generally recognized as safe and effective for its labeled use; marketing it requires an approved NDA or ANDA, an OTC monograph, or an IND during investigation. FDA approves products and their labeling, not "uses" - so a prescriber may lawfully prescribe off-label, while a manufacturer may not promote off-label.

Adulteration versus misbranding

Adulteration concerns the product itself: filth, decomposition, insanitary conditions, subpotency, wrong strength, unapproved manufacturing. Misbranding concerns words and paperwork: false or misleading labeling, missing required information, missing or expired dating, absent Rx legend, or no adequate directions for use. A prescription drug is exempt from the adequate-directions requirement because the prescriber supplies directions, but it must still bear the legend statement.

Approval and supply-chain concepts

  • Prescription versus OTC status; switches; the legend requirement.
  • Generic substitution is a state-law function; FDA therapeutic equivalence ratings inform but do not compel substitution.
  • REMS, postmarketing reporting, and recall classes (I, II, III).
  • DSCSA: transaction information, verification, and serialization duties for trading partners.
  • 503A (patient-specific, state-licensed, USP standards) versus 503B (FDA-registered outsourcing facility, cGMP).

Traps

  • Confusing FDA's role in promotional labeling with FTC jurisdiction over consumer advertising of OTCs.
  • Assuming an imported or foreign-labeled product is acceptable because the molecule matches.
  • Assuming a compounded copy of a marketed drug is always lawful.

Rule of thumb: a product defect is adulteration; a label or paperwork defect is misbranding.

Worked example: An antibiotic is dispensed with a label that omits the pharmacy phone number and prescription number. The drug is fine, but the label is deficient - a misbranding exposure and a Board dispensing-label violation at the same time.