Title 21 CFR reference

This part applies to all solid oral dosage form human drug products, including prescription drug products, over-the-counter drug products, biological drug products, and homeopathic drug products, unless otherwise exempted under § 206.7.

(a) Unless exempted under § 206.7, no drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature. (b) A holder of an approved application who has, under § 314.70 (b) of this chapter, supplemented its application to provide for a new imprint is not required to bring its product into compliance with this section during the pendency of the agency's review. Once the review is complete, the drug product is subject to the requirements of the rule. (c) A solid oral dosage form drug product that does not meet the…

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.

(a) The following classes of drug products are exempt from requirements of this part: (1) Drug products intended for use in a clinical investigation under section 505(i) of the act, but not including drugs distributed under a treatment IND under part 312 of this chapter or distributed as part of a nonconcurrently controlled study. Placebos intended for use in a clinical investigation are exempt from the requirements of this part if they are designed to copy the active drug products used in that investigation. (2) Drugs, other than reference listed drugs, intended for use in bioequivalence studies. (3) Drugs that are extemporaneously compounded by a licensed pharmacist, upon receipt of a valid prescription for an individual patient from a practitioner licensed by law to prescribe or administer drugs, to be used solely by the patient for whom they are prescribed. (4) Radiopharmaceutical drug products. (b) Exemption of drugs because of size or unique physical characteristics: (1) For a drug subject to premarket approval, FDA may provide an exemption from the requirements of § 206.10 upon a showing that the product's size, shape, texture, or other physical characteristics make…