June 2, 2022
APC’s OneFund helps us help you
Here at APC, we do a lot with a little: we’re a small organization and our resources aren’t bottomless. But we’re scrappy, and when we tackle an issue, the results are usually good for your compounding practice.
Most recently, we’ve launched a portal to help our members aggregate patient-reported outcomes to prove to FDA that compounded medications are benefitting millions of patients. Via our Legal Action Fund, we’ve filed two recent amicus briefs in court cases, one defending your right to compound methylcobalamin and another addressing ambiguity in FDA’s insanitary conditions guidance.
We’re also:
- Proposing to TRICARE a pilot project to demonstrate that compounded medications can help the agency achieve desired health outcomes and contain costs.
- Talking with FDA about the practical flaws in its “final” GFI 256 on veterinary compounding—flaws that may impede animal healthcare.
- Developing a “decision points document” to assist state boards of pharmacy in implementing and enforcing USP 800.
- Proposing a DQSA fix that would eliminate the 25-year-old MOU, mandate reporting to state regulators by pharmacies that ship more than 50 percent of their compounded medications out of state, and create in law a narrow path for 503As to provide shortage drugs to hospitals and clinics.
- Advocating to enable 503Bs to manufacture generics that have been off-patent for 20+ years, are on FDA’s essential drug list, and do not have a U.S.-based manufacturer. Our intent with this is threefold: address drug supply chain issues, stimulate stateside manufacturing, and strengthen the 503B business model.
- Working with FDA and Congress to insist that compounding pharmacies’ 483 files be closed out within a more reasonable timeframe.
- Providing our members an online payments platform that is integrated with the major compounding softwares.
But none of this stuff happens without funding—and right now, APC is running low on funds to support our advocacy work.
If you find the list above impressive—if you think the work we’re doing benefits your patients or your profession or the pharmacy or facility you work for—please click below:
OneFund is supported by gifts from members like you. It’s how we pay for our advocacy work. Right now—almost halfway into the year—OneFund has only raised 15% of its 2022 funding goal. That means our ability to keep doing what we’re doing is at risk.
Please invest now, so we can keep watching out for you.
