21 Code of Federal Regulations Parts 211 Subpart A-General Provisions

21 Code of Federal Regulations

Parts 211

Subpart A-General Provisions

211.1 Scope

(a) The regulations in this part contain the minimum current good manufacturing practice for

preparation of drug products for administration to humans or animals.

(b) The current good manufacturing practice regulations in this chapter, as they pertain to drug

products, and in parts 600 through 680 of this chapter, as they pertain to biological products for

human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.

(c) Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.

§ 211.3 Definitions.

The definitions set forth in § 210.3 of this chapter apply in this part.

Comments

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