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 hormones—therapies 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’re providing our members access to an online payments platform that will integrate with the major compounding software.
We’ve launched a new Career Center to assist our members in recruiting qualified employees.
December 1: An APC webinar: Uncovering Tax Incentive Opportunities for Your Compounding Pharmacy
December 6: An APC webinar, Practically Indispensable: How You Can Become an Elite Pharmacy Tech
December 8: An APC webinar: How to Use Medical Literature to Identify and Support Compounded Therapies
December 14: An FDA CDER webinar, What to Expect after an Inspection: 483s, Responses and Beyond
February 9–10: APC’s EduCon 2023, virtual (more details coming soon)
March 26–28: APC’s Owner Summit 2023; The Grand Hotel Golf Resort + Spa; Point Clear, AL (more details coming soon)
September 19–20: APC’s Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC
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