From APC's CEO

Something’s coming. Something good. 

Before you yawn, think about it: Lots of training—including on-the-job training—can prepare your team members on how to compound. But there are fewer affordable resources out there to provide your team members front-end training on the laws and rules and regs and standards and GFIs that form the regulatory framework for compounding ethically and compliantly.

That’s what our certificate is designed to do: To help you assure your compounding team know their stuff—not just the how, but also the why. 

By the way, “we” in that first paragraph above is APC plus the Pharmacy Compounding Foundation and the Virginia Commonwealth University College of Pharmacy. We’re delighted to have such extraordinary partners in this project.

For now, stay tuned. It’s coming. And it’s gonna be good.

Read on for this week’s news.

– Scott

Scott Brunner, CAE, is APC’s chief executive officer. Email him at scott@a4pc.org.

ICYMI

Catch up on these recent stories that you might've missed:

• APC to Tennessee BOP: Where’s the benefit?
• APC to California BOP: How do proposals protect patients?
• APC to Montana legislators: Please reconsider
• Makena withdrawal creates confusion for compounders

This week

Hey CVM, we have a few more questions…

APC this week asked FDA’s Center for Veterinary Medicine to provide additional guidance on compliance with its GFI 256 on animal drug compounding. In a letter to the CVM’s Dr. Bill Flynn, APC raised several issues that have come up in our training sessions for members. 

The letter asks CVM to clarify whether compounded drugs should be allowed when a drug is not available due to supply chain issues or backorders. The FDA had previously said that compounders should contact the agency in case of a drug shortage but that the agency does not provide blanket enforcement discretion for compounding copies of drugs in shortage.

The letter also takes issue with CVM’s assertion that compounders are expected to know what ingredients may be harmful or cause side effects to the species for which the drug is being compounded. 

“Because they are not listed in the approved package insert, it simply is not possible for pharmacists to know the excipients in manufactured animal drug products,” the letter states. 

GFI 256 Compliance Webinar available on-demand until June 15

Such a lovely place: California board rejects further changes to proposals

The California Board of Pharmacy met yesterday to discuss proposed regulations on non-sterile, sterile, and hazardous compounding.

Numerous comment letters, including one from APC, had been submitted to the board for consideration, along with a host of live public comments from attendees during the meeting. Just as APC’s letter did, several commenters urged the board to demonstrate how the proposals improved patient safety and were rooted in science.

Nevertheless, the board made no further changes, and voted unanimously to move the proposals into the rule-making process, with an anticipated enforcement date of November 1, 2023. Under California law, that process will include opportunities for additional stakeholder input.

Pharmacy owners: You’re gonna need this bucket

Save these dates

Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of two self-guided, online courses:

• Aseptic Process Simulations (Media Fills)
• Stability and Beyond-Use Dates

May 25: An APC webinar, IV Nutrition in Compounding. More details coming soon.

June 1: APC Fellows Program application deadline

June 6: An APC webinar, Popular Compounds and Unique Ingredients for Cosmetic Compounding.

June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know. More details coming soon.

September 19–20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC

2024

April 4-6: Owner Summit, La Jolla, CA

Short takes

Where in the world was APC's CEO this week? In Montreal, visiting APC partner Medisca! In addition to meeting with the executive team there, he also provided an issues briefing to Medisca's sales team. We're grateful for Medisca's long, strong support of APC.

Heads up on HIPAA enforcement. Starting May 11, the HHS Office for Civil Rights will begin enforcing important security measures in technologies that pharmacies and other HIPAA-covered entities use all the time for vaccine scheduling, telehealth appointments, or storing and transmitting protected health information. The 90-day transition grace period will expire on August 9.

FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. Earlier this week, FDA amended the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.

And speaking of FDA... The agency has updated the compounding Know Your Bulks and Excipients Suppliers webpage to provide guidance, resources, examples of quality issues with bulk drug substances and excipients, and FDA actions against manufacturers and re-packagers of active pharmaceutical ingredients because of significant violations of current good manufacturing practice requirements. 

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill

Continuing education

• Live webinars

• On-demand webinars

Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding

• Prohibition on peptide compounding

• La Vita Case amicus filing

• Insanitary Conditions amicus filing

EduCon 2023

Owner Summit 2023

Prescriber Briefing Resources

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Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund

Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members

Affinity service providers

• Accounting & Tax Services: Rx Advisors

• Audible Sunshine

• Office Equipment: TUI Solutions

• Online Payments Platform: HealNow

• Patient-Reported Outcomes: OutcomeMD

• Pharmacy Technician Certification Board

• Shipment Trackers, a shipping costs auditor  

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.