APC: ! What We’re Working On

! What We're Working On

We’re pushing back against FDA’s recent back-door reclassification of DTE as a biologic.

We’re analyzing USP’s new Chapters <795> and <797> and will be providing members guidance on compliance.

We’ve developed a series of member-only briefing documents to help you educate physicians and other prescribers about compounding on topics such as “The Truth About Pharmacy Compounding” and “Compounding Peptides: It’s Complicated.”

We’ve launched a portal to help our members aggregate patient-reported outcomes to demonstrate that compounded medications are benefitting millions of patients.

We’re working to save compounded hormonestherapies that benefit millions of Americans – in the wake of implicit threats to restrict them. Learn more about our campaign at compounding.com.

Via our Legal Action Fund, we’ve filed two recent amicus briefs in court cases, one defending compounders’ right to compound methylcobalamin and another addressing ambiguity in FDA’s insanitary conditions guidance.

We’re talking with FDA about the practical flaws in its “final” GFI 256 on veterinary compounding—flaws that may impede animal healthcare.

We’re developing a “decision points document” to assist state boards of pharmacy in implementing and enforcing USP 800.

We’re advocating for eliminating the 25-year-old MOU, mandating reporting to state regulators by pharmacies that ship more than 50 percent of their compounded medications out of state, and creating a narrow path for 503As to provide much needed shortage drugs to hospitals and clinics.

We’re working with FDA and Congress to insist that compounding pharmacies’ 483 files be closed out within a more reasonable timeframe.

We’ve provided our members access to an online payments platform that will integrate with the major compounding software.

We’ve launched a Career Center to assist our members in recruiting qualified employees.