FDA Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities

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Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities[附网盘链接]是于不久之前发布的FDA标准，适用于美国。

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Compounding and Repackaging of Radiopharmaceuticals by State-

Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION AND SCOPE This guidance sets forth the FDA’s policy regarding the compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies, Federal facilities, and 2

other entities that hold a radioactive materials (RAM) license for medical use issued by the 3,4

Nuclear Regulatory Commission (NRC) or by an Agreement State. Under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities, and radiopharmaceuticals that are repackaged, are subject to all applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs. Because Congress explicitly excluded radiopharmaceuticals from section 5

503A of the FD&C Act, compounded radiopharmaceuticals are not eligible for the exemptions under section 503A from section 505 (concerning new drug approval requirements), section 502(f)(1) (concerning labeling with adequate directions for use), and section 501(a)(2)(B) (concerning current good manufacturing practice (CGMP) requirements). In addition, the FD&C Act does not provide an exemption for repackaged radiopharmaceuticals. 1

This guidance has been prepared by multiple offices in the Center for Drug Evaluation and Research and in consultation with the Office of Regulatory Affairs at the Food and Drug Administration. 2

See 10 CFR 35.2 3

The NRC defines an Agreement State in part as one that has entered into an agreement with the NRC under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021). 4

This guidance only applies to entities that are not registered with FDA as outsourcing facilities. Outsourcing facility refers to a facility that meets the definition of an outsourcing facility under section 503B(d)(4) of the FD&C Act. 5

Section 503A of the FD&C Act describes the conditions that must be met for drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to qualify for exemptions from sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act. Section 503A(d)(2) of the FD&C Act states that “this section shall not apply to . . . radiopharmaceuticals.”

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