§ 206.3 Definitions.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
The following definitions apply to this part:
The actet seq. means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 ).
Debossed means imprinted with a mark below the dosage form surface.
Drug product means a finished dosage form, e.g., a tablet or capsule that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
Embossed means imprinted with a mark raised above the dosage form surface.
Engraved means imprinted with a code that is cut into the dosage form surface after it has been completed.
Imprinted means marked with an identification code by means of embossing, debossing, engraving, or printing with ink.
Manufacturer means the manufacturer as described in §§ 201.1 and 600.3(t) of this chapter.
Solid oral dosage form means capsules, tablets, or similar drug products intended for oral use.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.