USP Issues Clarification on General Chapter
The USP <800> final standards are more closely aligned with the Food and Drug Administration’s (FDA) definition of compounding, making activities such as the administration of a sterile medication and the preparation of drugs (mixing, reconstituting and other acts) not subject to the compounding standards in <797>.
Enforcement of USP standards is the responsibility of the FDA, state governing bodies and other regulatory authorities. USP has no role in enforcement. Because USP <800> can be used in healthcare settings beyond compounding at the discretion of regulatory authorities and other oversight organizations, your practice should contact your state governing body (pharmacy board, regulatory agency, accrediting organization, etc.) regarding compliance guidelines.
USP <800> is designed to protect both your patients and staff from potentially hazardous exposures. Regardless of this clarification, practices should still consider following the guidelines for Personal Protective Equipment (PPE) and Closed System Drug-Transfer Devices (CSTD).
For more information on the clarification or how it may affect your practice, send an email to firstname.lastname@example.org.