American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
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Am J Health Syst Pharm · Jan 2001
ReviewRegulation of the compounding of positron emission tomography drugs.
Controversial aspects of the regulatory framework for compounding drug products used in positron emission tomography (PET) are discussed. The Food and Drug Administration Modernization Act of 1997 (FDAMA), which amends the Federal Food, Drug, and Cosmetic Act (FFDCA), required that FDA establish approval (new drug application [NDA] and abbreviated new drug application [ANDA]) procedures and current good manufacturing practice (CGMP) requirements for PET drugs; this seems to conflict with differentiation between manufacturing and compounding in FFDCA. Compounding by pharmacists is implied in the FDAMA section on PET, but specific mention of "pharmacist" needs to be included. ⋯ Without relief from the current regulations, many academic PET centers are likely to close; this would violate FDAMA's stated intent of making PET available to patients at reasonable cost. Also problematic is FDAMA's prohibition of compounding "regularly or in inordinate amounts" a product that is commercially available; the common PET radiopharmaceutical fludeoxyglucose F 18 injection, for example, is commercially available. A sensible alternative to NDA or ANDA and CGMP requirements would be the enforcement of USP standards for PET drugs by state boards of pharmacy.