The Pharmacists Forum – Regulatory News Updates

193 Words – 2 min Read. Written by Dr. Mike Shafor Pharm.D., RPH – General Manager PharmaLabs

On November 1, 2023, the United States Pharmacopeia (USP) will be revising its regulatory standards for pharmaceutical compounding and the handling of hazardous drugs. Once the regulatory revisions are accepted by USP, all states will adopt the new regulation in-whole or in-part, and state statutes will be revised accordingly.

What this means for you

Sterile injectable medication compounding will be affected nationally, as compounding pharmacies will be required to limit beyond-use dating on sterile preparations significantly, altering production schedules, increasing costs, and, unfortunately, in many cases, making it unfeasible to produce custom batches of sterile preparations for many compounding pharmacies.

How we’re helping menMD providers prepare

PharmaLabs has been preparing for these regulatory changes for quite some time and is working diligently to complete all newly required testing on our product line to ensure that new regulatory requirements do not get in the way of our medications reaching your patients. If you would like more information concerning regulatory changes related to USP <797>, USP <795>, or USP <800>, feel free to reach out to Dr. Mike Shafor, Pharm.D., RPH, with your questions or concerns. PharmaLabs is here to support you!