USP <823> - Positron Emission Tomography Drugs for Compounding, Investigational and Research Uses

What it says

Positron emission tomography drugs must meet quality standards addressing sterility, radiochemical identity and purity, and other quality attributes specific to PET radiopharmaceuticals, accounting for their extremely short half-lives and the compressed timeframes under which they are prepared and released for patient use.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• PET drugs carry an even more compressed timeline than many other radiopharmaceuticals covered under USP <825>, since PET isotopes typically have half-lives measured in minutes to a few hours, making the design of a scientifically valid rapid-release program especially critical.
• Radiochemical purity testing specific to PET drugs addresses a quality attribute that does not have a direct analog in most conventional pharmaceutical testing, since it is evaluating the chemical form of the radioactive label itself, not just the molecule it is attached to.
• Because PET drugs are often prepared at or near the clinical site rather than centrally manufactured, this chapter's standards are particularly important for facilities operating under a different production model than conventional pharmaceutical manufacturing.

What inspectors look for

• Whether a validated rapid-release testing program actually supports release decisions made within the extremely compressed timeframes PET drug half-lives require.
• Whether radiochemical purity testing is performed using methods validated specifically for the PET drug's chemical form, not borrowed unchanged from conventional pharmaceutical testing.
• Whether facilities preparing PET drugs at or near the clinical site maintain the same sterility and quality assurance rigor expected of conventional radiopharmaceutical production.

Related regulations