The voice for pharmacy compounding │ 24 March 2023
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Three scenes from this past week | |
1) As I write this, it’s Thursday and I’m multi-tasking: I’m also listening in on the meeting of the California Board of Pharmacy Compounding Committee as it considers additional regulation of non-sterile compounding in that state. APC’s public policy counsel David Pore is offering comment, as are many pharmacy compounders licensed in California. Will they be heard and heeded? I don’t have high hopes. It’s California, after all. | |
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2) On Wednesday, 279 compounders participated in a CE webinar co-sponsored by APC and PCCA. The topic: compliance with GFI 256 on animal compounding, enforcement for which begins April 1. Presenters AJ Day and Matt Martin provided a superb briefing on bringing your practice into compliance as we presently understand it. If you missed the live event, good news: We’ll be making the video available for purchase in about 10 days, though not for CE credit, so stay tuned. (Also, remember to download our new Prescriber Brief to help the vets you work with will understand documentation of medical rationale.)
3) File this under “solutions in search of a problem.” The Tennessee Board of Pharmacy is proposing that the name of every compounding team member that touches a preparation must be listed on the label. APC spent time this week preparing a comment letter. If you’re licensed in Tennessee, you need to comment as well. Here’s the scoop.
APC’s Owner Summit convenes this Sunday in Point Clear, Alabama. I’m headed that way, and we’ll have a report (and pictures!) in next week’s CC. For now, read on for more compounding news…
– Scott
Scott Brunner, CAE, is APC’s chief executive officer. Email him at scott@a4pc.org.
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Catch up on these recent stories that you might've missed:
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California BOP compounding proposals out of sync with national standards | |
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As you read above, the California Board of Pharmacy’s Enforcement and Compounding Committee met yesterday to discuss proposed regulations related to sterile compounding.
During the four-hour-long meeting, APC legislative and regulatory counsel David Pore shared concerns about how proposed changes to regulations will impact patients in the state. Notably, the proposals are inconsistent with USP 797, aim to make USP Chapters 1000 and above enforceable in California – something USP itself clearly does not recommend – and state that items on FDA’s interim list for bulk substances may not be compounded.
APC is submitting a formal comment letter addressing our serious concern that the proposals are well out of sync with nationally recognized standards, will sow confusion among licensees and dampen their ability to serve patients.
“Patient access is the real issue here,” says APC’s Scott Brunner. “These policies aren’t rooted in any particular science and well exceed national standards like USP and FDA guidance. The California BOP has not demonstrated how patients are made safer by these proposals. Instead, this is a state agency charged with protecting the public that is pursuing restrictions that will ultimately disadvantage California patients who rely on compounded medications to live normal lives.”
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Racehorses, compounding and confusion | |
In recent weeks there’s been a persistent rumor that the governing body for horse-racing has banned compounded drugs because they are not FDA approved. But that’s not the case.
While the syntax is a bit convoluted, the Horseracing Integrity and Safety Authority's new Rule 4111 states that compounded drugs are clearly permissible:
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| Rule 4111. S0 Non-Approved Substances
Any pharmacological substance that (i) is not addressed by Rules 4112 through 4117, (ii) has no current approval by any governmental regulatory health authority for veterinary or human use, and (iii) is not universally recognized by veterinary regulatory authorities as a valid veterinary use, is prohibited at all times. For the avoidance of doubt, compounded products compliant with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 (also known as Compounding Animal Drugs from Bulk Drug Substances) are not prohibited under this section S0. | | |
Coming soon: Compounding certificate program for your new hires | |
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Consider this a teaser. Sometime in late spring, we’ll be debuting a new 15-hour certificate program, “The Ethical, Legal, and Regulatory Framework of Pharmacy Compounding.” The program is being developed as a collaboration between APC, the Pharmacy Compounding Foundation, and the Virginia Commonwealth University School of Pharmacy.
“We’re creating this learning program based on the premise that understanding the regulatory framework for compounding is just as important as knowing how to compound,” said APC’s Scott Brunner. “And with a price point under $500, we aim for it to become the foundational learning program for new pharmacy compounding team members.”
Topics covered will include laws and regulations, safety, quality, training, and credibility.
Stay tuned for roll-out in May or June.
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March policy video: Here’s what’s happening | | |
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Check out the latest public policy update video from APC Director of Public Policy Savannah Cunningham, PharmD. It highlights five things you need to know right now about APC, our industry, and our advocates. It’s short, not even 4 minutes long—perfect for showing at your next pharmacy team meeting. | |
Hosted by APC Director of Public Policy Savannah Cunningham, each month we share a short video focused on five things you need to know right now and how you can help us in protecting and promoting your compounding practice. | |
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Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of a self-guided, online course: Aseptic Process Simulations (Media Fills)
March 26–28: APC's Owner Summit 2023, The Grand Hotel Golf Resort + Spa;
Point Clear, Alabama
April 6: An APC webinar, Making the Case for Advanced Pharmacy Technicians
April 20: An APC webinar, Compounding for Women’s Health Conditions
May 25: An APC webinar, IV Nutrition. More details coming soon.
June 1: APC Fellows Program application deadline
June 6: An APC webinar, Compounding for Cosmetic Needs. More details coming soon.
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
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Drug shortages show no signs of abating. According to a recent article, drug shortages are the worst they've been in a decade. Causes have been attributed to quality control issues, limited plant capacity, plant closures, and other manufacturing concerns. The short supply of important medications—local anesthetics, albuterol solution, multiple cancer therapies—are causing trouble for hospitals and their patients.
Product obligations update. FDA released final guidance this week that will help dispensers better understand their obligations under the Drug Supply Chain Security Act (DSCSA) related to “suspect” and “illegitimate” products. The new guidance, titled “Definitions of “Suspect Product” and “Illegitimate Product” for Verification Obligations Under the DSCSA,” is effective immediately.
America, we have a problem. A couple years ago, the nonpartisan and objective research organization (NORC) at the University of Chicago produced an eight-year analysis of obesity rates in America with funding from Novo Nordisk, the company that produces both insulin and Ozempic, one of the popular weight-loss drugs. (Maybe you’ve heard of it?)
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