We launched a 15-hour virtual CE program–The Ethical, Legal and Regulatory Foundations of Pharmacy Compounding–on August 1, 2023. Priced at $495, the program serves as entry-level training for compounding pharmacists and technicians.
We’re working with compounders licensed in California, to illuminate how the rules proposed by the California Board of Pharmacy go above and beyond the national standards set by USP.
We’re advocating for HR 167, legislation that would allow compounders temporarily to provide “urgent use” medications to hospitals and clinics when those drugs are in shortage. Read our recent op-ed in STAT.
We’re developing federal legislation that would:
• Eliminate the MOU and replace it with reporting by pharmacies that ship more than 50 percent of their production out of state
• Establish an adverse event reporting framework for 503A pharmacies
We sent a memo to assist state boards of pharmacy in implementing and enforcing USP <797>.
We’re pushing back against FDA’s recent back-door reclassification of DTE as a biologic.
We’re advising FDA to assure clear understanding of compliance standards and enforcement on GFI 256, regarding veterinary compounding.
We’ve released a series of member-only briefing documents to help you educate prescribers about compounding on topics such as “The Truth About Pharmacy Compounding” and “Compounding Peptides: It’s Complicated.”
With amoxicillin in shortage, our advocacy resulted in FDA issuing guidance creating a path by which 503A pharmacies can more easily compound beta lactams.
We’ve launched a portal to help our members aggregate patient-reported outcomes to demonstrate that compounded medications are benefiting millions of patients–data that will be essential in making a case for cBHT if FDA moves to restrict it.
Via our Legal Action Fund, we filed two amicus briefs last year in court cases, one defending compounders’ right to compound methylcobalamin and another addressing ambiguity in FDA’s insanitary conditions guidance.
Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of these self-guided, online courses:
December 7: An APC webinar, Automation and USP 797 (rescheduled)
December 12: An APC webinar, Compounding Pharmacy Medication Errors – What the Data Says.
December 14-16: A4M Longevity Fest 2023 in Las Vegas, NV
December 19: An ARL webinar, Wait…What? That’s Interesting. A Functional Approach to Quality Sterile Compounding
January 11: OutcomeMD Lunch & Learn program for existing users
January 28: An APC webinar, Survey of State Compounding Law Changes 2024. More details coming soon.
March 14: OutcomeMD Lunch & Learn program for existing users
April 4-6: Owner Summit, La Jolla, CA
May 9: OutcomeMD Lunch & Learn program for existing users and those interested in learning more
June 20-21: EduCon Virtual: The Ethical Compounding Conference
September 17-18: Compounders on Capitol Hill (CCH) in Washington D.C.