USP Revised Compounding Standards Postponed.

USP Announced the recent revision of <795>, <797>, and <825> will not be enforceable while it is going through the appeal process brought on by IACP, which through many of it’s members lobbied to revise the standard again. The new Beyond Use Dating (BUD) was in contention throughout the industry and directly effected 503A pharmacies and other non-traditional compounders. USP<800> now becomes informational and not compendially enforceable. The 2014 version of USP<795> and 2008 version of USP<797> are still enforceable and should be used as reference until State Boards Of Pharmacy (SBOP) or other regulatory bodies decide which standard and version to uphold and enforce.

Veterinary facilities and other non-traditional compounders should use this time to prepare for the revision to pass the appeal process.

All organizations should maintain compliance with OSHA hazardous substance laws and regulations.

Not sure whom to prepare for or what standards to comply with, contact us for a free 30 minute consultation.

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