(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 imprinting technologically infeasible or impossible.
(i) Exemption requests for products with approved applications shall be made in writing to the appropriate review division in the Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266 or the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. If FDA denies the request, the holder of the approved application will have 1 year after the date of an agency denial to imprint the drug product.
(ii) Exemption requests for products that have not yet received approval shall be made in writing to the appropriate review division in CDER or CBER.
(2) Any product not subject to premarket approval is exempt from the requirement of § 206.10 if, based on the product's size, shape, texture, or other physical characteristics, the manufacturer or distributor of the product is prepared to demonstrate that imprinting the dosage form is technologically infeasible or impossible.
(c) For drugs that are administered solely in controlled health care settings and not provided to patients for self-administration, sponsors may submit requests for exemptions from the requirements of this rule. Controlled settings include physicians' offices and other health care facilities. Exemption requests should be submitted in writing to the appropriate review division in CDER or CBER.