FDA Publish Rules on PET Drugs GMP
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This guidance is intended to help small businesses better understand and comply with the regulations issued by the Food and Drug Administration (FDA) concerning current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The guidance addresses resources, procedures, and documentation for all PET drug production facilities. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements. FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
FDA’s guidance documents, including this guidance, should not be viewed as establishing legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Section 121(c)(1)(A) of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act) directed FDA to establish CGMP requirements for PET drugs. FDA established these requirements in 21 CFR part 212
As directed by Congress in the Modernization Act, to help in developing the PET CGMP regulations and this guidance, we closely examined the operations of many PET drug producers, including not-for-profit institutions and commercial manufacturers. Since the Modernization Act became law, significant changes have occurred in PET drug production in the United States. The number of PET drug production facilities has increased, as has the number of facilities where PET scans are performed. The business of PET drug production has changed as well. Historically, PET drugs were produced by academicians and researchers at PET drug production facilities located in universities and similar not-for-profit institutions. An academically oriented PET drug production facility usually produces small amounts (a few doses per day) of a few PET drugs for on-site patient use and a larger variety of PET drugs for clinical investigation and academic research.
An increasing number of PET drug production facilities are now operated by for-profit corporate entities that contract with academic and medical institutions (many of which have not-for-profit status) to manage the production of PET drugs at those institutions. Most of these PET drugs are administered on site, although often there is some distribution to other local or regional hospitals. In addition, a growing number of independent PET drug production facilities are not affiliated with any university or hospital. These for-profit, often contractually managed, and independently operated PET drug production facilities distribute PET drugs to significantly greater numbers of patients, sometimes hundreds of miles from the production site.
Our review of PET drug production has led to the conclusion that a PET drug producer’s status as either a not-for-profit or for-profit entity has little bearing on the quality of PET drugs that it produces and distributes for administration to patients, or on the methods, facilities, and controls that a PET drug production facility needs to ensure product quality. Instead, production and CGMP differences among PET drug producers are primarily a function of the size, scope, and complexity of their production operations. We have also found that implementing certain production standards and controls can ensure the production of quality PET drugs, regardless of differences among the various PET drug production facilities. The Agency believes that the welfare of a patient undergoing a PET scan should not depend on where a particular PET drug was produced.
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