Current Good Manufacturing Practice for Positron Emission Tomography Drugs
other · Food and Drug Administration · Rule · Published 2009-12-10 · Effective 2011-12-12 · 74 FR 65409
Document
Document number
E9-29285
Federal Register citation
74 FR 65409
CFR reference
21 CFR 210
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-12-10
Effective date
2011-12-12
HHS docket
Docket No. FDA-2004-N-0449
Abstract
The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled "PET Drugs--Current Good Manufacturing Practice (CGMP)."