503B Compounding Pharmacy

The Pharmacy Times® 503B Compounding Pharmacy Resource Center is a comprehensive resource for clinical news and expert insights on issues related to compounding pharmacies and drug safety.

Latest News

Navigating FDA Compounding Regulations: Tirzepatide's Removal From the Shortage List and Its Impact on 503A and 503B Facilities
Navigating FDA Compounding Regulations: Tirzepatide's Removal From the Shortage List and Its Impact on 503A and 503B Facilities

November 1st 2024

Martha Rumore, PharmD, Esq, discusses the legal and regulatory complexities surrounding tirzepatide compounding following FDA’s removal of the drug from the shortage list, which prompted a lawsuit and led to ongoing uncertainty for 503A and 503B facilities regarding enforcement discretion and future compounding restrictions.

Clinicians, Pharmacists Should Work to Ensure Safety Compounded GLP-1 Medications
Clinicians, Pharmacists Should Work to Ensure Safety Compounded GLP-1 Medications

October 23rd 2024

Tirzepatide, FDA, Drug Shortage, Lawsuit | Image Credit: Cynthia - stock.adobe.com
Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide From Drug Shortage List

October 14th 2024

503B, 503A, compounding pharmacy
Regulatory Considerations Regarding the 503B to 503A Compounding Model For Community Pharmacies

June 26th 2024

Image credit: luchschenF | stock.adobe.com
Proper Use of Automation in Hazardous Drug Compounding Pharmacies

January 16th 2024