FAQs: <823> Radiopharmaceuticals for Positron Emission Tomography (PET)—Compounding, Investigational, and Research Uses

Last updated: January 26, 2011

1. What is General Chapter ?

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.

2. How are the provisions of General Chapter enforced?

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.

3. How do I know if I should follow General Chapter or the PET drug CGMP regulations?

USP has submitted a Citizen Petition to FDA to update the compendial reference to <823> in the federal regulations on current good manufacturing practice (cGMP) for PET drugs (21 CFR § 212.5(b)) from USP 32-NF 27 to USP 35-NF30 to reflect the currently official version of <823>. FDA has formally acknowledged this request. Until such time that the FDA updates part 212, please see the archived version of <823>.

4. What are some of the areas addressed by the revisions to Chapter ?

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.

5. What is the status of USP monographs for PET drugs that are approved by the FDA?

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.