APC: Legal settlement spurs FDA to develop 503B bulks list

APC Resources

FDA issues public statement on compounded semaglutide

Earlier this week, FDA issued its first public statement on semaglutide compounding. The statement elaborates on what the agency said in its April letter to NABP on the subject. read more →
Call to Action on Urgent Use: Have you responded?

Send a message to your respective members of Congress, asking them to support legislative language that will allow pharmacy compounders to help fill urgent gaps in the drug supply chain. read more →
Compounding Compliance Conference: APC members get a discount

APC members are invited to attend Informa Connect’s two-day program, Compounding Pharmacy Compliance at a special, members-only rate (use code 23A4PC15 to receive 15 percent off your registration fee). read more →
FDA hears from APC leaders

Earlier this week, APC’s Executive Committee and Federal Legislative Committee leaders met virtually with FDA’s Office of Compounding Quality + Compliance team to discuss a range of issues impacting pharmacy compounding. read more →
Show ‘em your briefs!

APC and the Pharmacy Compounding Foundation offer a series of briefing papers to help you educate prescribers about a range of pharmacy compounding topics. read more →
Tennessee expands State BOP

Tennessee Governor Bill Lee has approved Senate Bill 753, which expands the state’s Board of Pharmacy from seven members to nine members and creating designated seats for a pharmacy technician and a consumer member. read more →
There’s still time: Call to action on Urgent Use

We’re asking our members and supporters to send a message to your member of Congress, urging your elected officials to support legislative language enabling pharmacy compounders to help fill urgent gaps in the drug supply chain. read more →
Moser elected 2024 APC vice president

At its meeting this week in Alexandria, the APC Board of Directors unanimously elected Michelle Moser, Revelation Pharma/Makers Compounding Pharmacy, Mount Vernon, WA as Board Vice President for 2024. read more →
ACT Conference notches 130+ Hill visits

PCCA hosted its ACT Conference in Washington, DC, this week, with more than 80 compounders attending and more than 130 Hill visits conducted. Here’s a photo composite recapping just a few of those. read more →

More APC News

October 14, 2022

Legal settlement spurs FDA to develop 503B bulks list

The Outsourcing Facilities Association announced this week that it reached a settlement agreement with the FDA that will spur the agency to promptly review long-pending nominations for active pharmaceutical ingredients for use by FDA-registered 503B outsourcing facilities to compound drugs needed by patients.

OFA says the settlement of an OFA-supported lawsuit will allow 503B facilities to improve health care provider and patient access to certain medications and to ease drug shortages in a timely manner.