21 CFR 212.5 - To what drugs do the regulations in this part apply?

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§ 212.5 To what drugs do the regulations in this part apply?

(a)Application solely to PET drugs. The regulations in this part apply only to the production, quality assurance, holding, and distribution of PET drugs. Any human drug that does not meet the definition of a PET drug must be manufactured in accordance with the current good manufacturing practice requirements in parts 210 and 211 of this chapter.

(b)Investigational and research PET drugs. For investigational PET drugs for human use produced under an investigational new drug application in accordance with part 312 of this chapter, and PET drugs produced with the approval of a Radioactive Drug Research Committee in accordance with part 361 of this chapter, the requirement under the act to follow current good manufacturing practice is met by complying with the regulations in this part or by producing PET drugs in accordance with Chapter 823, “Radiopharmaceuticals for Positron Emission Tomography - Compounding,” May 1, 2009, pp. 365-369, 32d ed. of the United States Pharmacopeia (USP) National Formulary (NF) (USP 32/NF 27) (2009). The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the United States Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, Geeta M. Tirumalai, 301-816-8352, e-mail: gt@usp.org, Internet address: http://www.usp.org/USPNF/notices. You may inspect a copy at the Food and Drug Administration Biosciences Library, 10903 New Hampshire Ave., Silver Spring, MD, 20993-0002, 301-796-3504, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

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