USP Issues Clarification on General Chapter

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Specialty practices have been preparing for USP General Chapter <800>, the standard on the safe handling of hazardous drugs, to go into effect on Dec. 1, 2019. However, in a recent clarification, the United States Pharmacopeia (USP) stated that because USP <800> is cross-referenced to the standards that only pertain to compounded drugs (<795> and <797>) the changes under <800> may not apply to specialty practices that only handle hazardous drugs.
Specialty practices have been preparing for USP General Chapter <800>, the standard on the safe handling of hazardous drugs, to go into effect on Dec. 1, 2019. However, in a recent clarification, the United States Pharmacopeia (USP) stated that because USP <800> is cross-referenced to the standards that only pertain to compounded drugs (<795> and <797>) the changes under <800> may not apply to specialty practices that only handle hazardous drugs.
 
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).