§364b. Good manufacturing practice — Inbound Citations
21 U.S.C. § 364b
Cited by 6 provisions in release 119-102.
Citations to 21 U.S.C. § 364b as a whole
-
(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 364b of this title.
-
(a) Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
-
(a) Notwithstanding any other provision of law, except as provided in subsection (b), a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.
-
(b) A facility described in subsection (a) that also manufactures or processes cosmetic products that are not subject to the requirements of subchapter V shall not be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title, with respect to such cosmetic products.
-
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.