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            The voice for pharmacy compounding │ 1 March 2024             

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From our Board Chair

Peptides: Still complicated

A couple of years ago, APC released a brief for prescribers on peptide compounding. It was a response to a request from many of our members who were being asked by prescribers to compound peptides that fell outside federal law and FDA guidance for use in compounding. The title of that brief was “Compounded Peptides: It’s Complicated.”


Since the release of that brief, it hasn’t gotten any less complicated.

That’s why at its February 15 meeting, your APC Board of Directors authorized an update of and elaboration on that statement, with a direction to broaden the audience to not only prescribers and our members but also non-members and even regulators. The purpose: To educate us all not only about federal law and FDA guidance on peptides – particularly in light of FDA’s September 2023 addition of several peptides to Category 2 – but also to explain the pathway for re-nominating some of those substances for reconsideration by the agency. 

 

Here's an advance copy of our revised statement, titled “Understanding Law and Regulation Governing the Compounding of Peptide Products.”


Next week we’ll release that revised statement broadly to the media, state boards of pharmacy, and of course to our members and other compounders. We hope you’ll also share it with your colleagues and the prescribers you work with.

 

We don’t have to agree with FDA’s actions on peptides – and on plenty of other things as well. But we do have to adhere to laws and regulations. It’s a duty we owe our patients … and the credibility of our profession.


  Joe


Joseph P. Navarra, RPh, FACA, FAPC is the owner of Town Total Compounding Center in Woodbury, New York. You can reach him at joseph.navarra@towntotalcompound.com.

We respond to FDA Commissioner's misstatements


Yesterday, in public comments expressing concern about the sale of counterfeit and unverified substances purporting to be GLP-1 drugs, FDA Commissioner Robert Califf erroneously referred to them as compounded substances multiple times. We presume the commissioner’s conflation of legitimate compounded drugs with illicit substances was inadvertent. Regardless, it required a correction, which APC provided in a statement to news media yesterday. We’ve reached out to Califf’s office as well.

ICYMI


This week's news

PCCA is our newest Diamond-level supporter

Long-time APC partner PCCA is our newest Diamond-level Corporate Patron for 2024 and has committed additional funding to sponsor a series APC regional meetings this year.


“We treasure our strong relationship with PCCA and we’re grateful for all their support, both financial and through the expertise of their team,” said APC’s Scott Brunner. “Their increased investment this year allows us to expand the work we’re doing to protect patient access to compounded medications.”


APC also has three new Bronze-level Corporate Patrons—Medizap, Quartermaster Tax, and Rx MediSource. You can find more information on all of our Corporate Patrons on our website.

Letter asks justification for proposed Massachusetts fee increase


The Massachusetts Board of Registration in Pharmacy held a hearing February 28 on proposed new fees for pharmacy licenses in the state. The proposal would establish non-resident pharmacy license fees and increase resident pharmacy license fees significantly—well beyond other states' fees— particularly for non-sterile and sterile compounding. APC submitted a letter this week expressing concern and asking the board to clarify and provide justification for the proposed changes.

NCPA: Local pharmacies are running out of time


A new NCPA survey reveals local pharmacies are struggling to stay afloat after the January 1 implementation of the CMS DIR rule, requiring all pharmacy price concessions (i.e., DIR fees) to be assessed at the point of sale.


Almost one-third of respondents indicated they may close their doors this year because of the financial pressure.


For details, see NCPA’s report.

Florida will begin inspecting to new USP standards

The Florida Board of Pharmacy Compounding Subcommittee met last week to discuss the state’s USP 797 inspection process. Though USP 797 is not enforceable until November 1, 2025, the board will begin inspecting immediately based on the new chapter and indicating “no” if the pharmacy is not in compliance on inspection reports. The board intends for the reports to be educational, not punitive, as pharmacies begin moving toward compliance. 


Florida is one of a number of states following this approach. APC is preparing a state-by-state analysis of USP enforcement approaches that should be available in the next month. Stay tuned.

Short takes

APC fields more media calls on compounded GLP-1s. This week, APC’s Scott Brunner and Tenille Davis spoke with reporters from Scripps News, Bloomberg, and Politico, working to help them better understand pharmacy compounding and the important role you play in the lives and health of your patients. We don’t always tell you about them, but over the past year we’ve averaged about one inquiry a week from a major media outlet asking about compounded GLP-1s.


AMMG conference discount for APC members? Your connection to APC gets you a 20% discount on registration for all regular/3-day AMMG conferences. Use code ACR to get the discount.  

Belmar and CompPAC host Congresswoman Castor. Belmar Pharmacy hosted House Energy & Commerce Committee member Kathy Castor for a fundraiser and tour of their new Odessa, Fla. 503A pharmacy on February 20. We’re grateful to Belmar’s Dave Hill, Rob Kilgore, and their team for their leadership—and we thank Congresswoman Castor for her support.

Scott visits Dunwoody Pharmacy. While in Atlanta this week, Scott visited with owner – and APC individual member—Chuck Wilson at his sterile compounding pharmacy right outside the I-285 perimeter.


As a follow-up to the NY town hall call this week: If you want to support the advocacy efforts in New York to expand pharmacy technician compounding, you can make a financial contribution (checks only) to the Coalition for the Advancement of Small Business Pharmacy.

Building strong relationships on Capitol Hill is essential. We need to support policymakers who think like we do about small business, pharmacy compounding, and maintaining patient access to compounded medications. CompPAC opens doors for us to do that. Our fundraising goal for this year is $125,000 … and we have a long way to go.

Invest in CompPAC today (personal credit cards only). You’ll be doing right by your business and your profession.

Save these dates

This month


This year


On demand

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 (HR 167)

Adverse events reporting framework 

Saving compounded hormones


EduCon


Owner Summit


Prescriber Briefing Resources


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 

• TUI Total Solutions

• TxtSquad


Alliance for Pharmacy Compounding | A4PC.org

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.

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