Implications of the Food, Drug, and Cosmetic Act on the Quality Assurance of Radiopharmaceuticals used in the United States
The drug (defined in part as any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease) sections of the Federal Food, Drug, and Cosmetic Act (Title 21 U.S.C.) are intended to assure the consumer that drugs are safe and effective for their intended use. The Act requires that “new drugs” be approved by the FDA before they go on the market. The Act also prohibits importation or distribution of drugs that are adulterated (defective, unsafe or filthy) or misbranded (false, misleading statements or labeling). The regulations for the new drug review process are contained in the Code of Federal Regulations (CFR) Title 21, sections 312 for Investigational New Drugs (INDs) and 314 for New Drug Applications (NDAs). Section 361 deals with radioactive drugs for certain research (RDR) uses. The regulations require that sufficient information be provided on the acceptable limits and the analytical methods used for the assurance of the identity, strength, quality, purity and the stability of the new drug as well as the raw materials used in the preparation of the new drug. The impact of the Act on the control of radiopharmaceutical products will be discussed.
KeywordsDrug Product High Pressure Liquid Chromatography Drug Substance Unite States Pharmacopeia Radionuclidic Purity
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