Dosage form

Dosage form is the physical manifestation containing the active and inactive ingredients that delivers a dose of the drug product. This includes such factors as:
(1) The physical appearance of the drug product;
(2) The physical form of the drug product prior to dispensing to the patient;
(3) The way the product is administered; and
(4) The design features that affect frequency of dosing.

Source

21 CFR § 314.3

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Scoping language

The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter.

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