Frequently Asked Questions: <823> Radiopharmaceuticals for Positron Emission Tomography (PET)—Compounding, Investigational, and Research Uses
Posting Date: 26–Jan–2011
- What is General Chapter <823> ?
- How are the provisions of General Chapter <823> enforced?
- How do I know if I should follow General Chapter <823> or the PET drug CGMP regulations?
- What are some of the areas addressed by the revisions to Chapter <823>?
- What is the status of USP monographs for PET drugs that are approved by the FDA?
General Chapter <823>, Radiopharmaceuticals for Positron Emission Tomography (PET)—Compounding, Investigational, and Research Uses, provides quality assurance standards for PET drugs that are produced for compounding, investigational, or research purposes in the United States. General Chapter <823> was originally published in 1998 in the U.S. Pharmacopeia 23 —National Formulary 18 (USP 23–NF 18), 8th Supplement. Monographs for individual drugs and dosage forms as well as general chapter guidelines are published in USP–NF, the print and online compendium of official quality standards for drugs in the United States
Under a longstanding provision of the Federal Food, Drug, and Cosmetic Act (FDCA), drugs recognized in USP–NF must comply with compendial identity standards, as well as compendial standards for strength, quality, and purity, as set forth in applicable USP monographs and General Chapters. This is described in FDCA 501(b).USP has no role in enforcement, which is the responsibility of FDA and other government authorities.
In 2009, FDA issued final regulations and an accompanying guidance document to establish current good manufacturing practice (CGMP) requirements for PET drugs. These requirements are codified in the Code of Federal Regulations Title 21 Part 212 (Part 212) and became effective on December 12, 2011. Part 212 is intended for PET drugs that are FDA approved or in the late stages of the approval process. Investigational and research PET drugs may be produced according to Part 212 or General Chapter <823> as published in USP 32–NF 27.
In December 2013, recommendations were published by the Committee on Pharmacopeia (COP) of the Society of Nuclear Medicine and Molecular Imaging (see JNM, vol. 54, no 3, pp 472-475). This article recommended that USP monographs for PET drugs that are not FDA approved should be omitted from the USP-NF. Following this recommendation, in March 2014, the USP Committee of Experts voted to omit the eight monographs for non-approved PET drugs. These omissions appeared in Supplement 2 of the USP 37-NF 32, which becomes official on December 1, 2014.
In the same article cited in the previous question, the COP recommended that future USP monographs for PET drugs should be limited to FDA-approved products. Based on this recommendation, the existing USP monographs for FDA-approved PET drugs will be maintained according to standard USP policies.