CompoundingConnex5a.png

The voice for pharmacy compounding │12 August 2022

 

From APC's President

Prescribers say—and ask for—the darnedest things


There is not a week that goes by when a prescriber calls and questions the legitimacy of compounding, or asks me to compound HCG or tesamorelin. 


Let’s talk about these issues.


Yes, even today with compounding standards enhanced and most compounders really stepping up their game to ensure quality and safety, some question whether compounding of medications is legitimate. They see our profession as the “wild west” with no rules or regulation. You and I know nothing is further from the truth. We are among the most regulated professions in the world.


Anti-aging prescribers are also attempting to use peptides in their practices. They hear about peptides at conferences or read about them and believe they are the best therapeutic option to help their patients. Often times, they want to obtain peptides through a compounding pharmacy. They don’t understand when I tell them that I cannot compound these agents and that, in fact, it is illegal under federal law. In the few cases where it may be legal under federal law, the compounder may only be able to obtain analytical grade chemicals and not USP/NF grade peptides also required by law.


I’ve always wondered what to tell my physicians who push back and say “Joe’s Pharmacy in California is doing it, why can’t you?” Many of you have made the same inquiry to APC and we heard you.


APC has created two member-only documents entitled: 

  • The Truth About Pharmacy Compounding: A briefing for physicians and other prescribers
  • Compounding Peptides: It’s Complicated: A briefing for physicians and other prescribers


These are simple to read and concise documents which contain valuable information for your practitioners to help educate them on the issues. You can co-brand them with your pharmacy’s logo. They are a great way to retain a relationship with your practitioners when they don’t understand what we do and we and why we can’t do what we can’t. Click here to learn more and to access the briefs.


• • •


David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

ICYMI

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

Medisca-Transitional-Logo_Green-1 image
 

This week

SURVEY: Are you ready for GFI 256?

In April last year, the FDA’s Center for Veterinary Medicine released its GFI #256, “Compounding Animal Drugs from Bulk Drug Substances.” The GFI expresses the agency’s “current thinking” on the subject of compounding from bulk drug substances for animal health.


Maybe you knew this. But did you know that FDA plans to begin enforcement of the GFI on October 1, 2022? Compliance will mean that veterinary practices and compounding pharmacies will have to navigate through transformative changes in their policies, practices, and procedures.


We’re conducting a survey of compounding pharmacies to help APC understand your readiness for compliance with the GFI #256 – so that we can provide tools and training to support you in this transition and so that we can advise FDA about whether an enforcement delay is warranted.


Would you mind completing it? It should only take you about seven minutes.


Click here to take this quick survey.

CCH hotel room block filling up fast

CCH-2022_Register-Now-Button_June-2022 image

APC's Compounders on Capitol Hill is a little more than a month away. PLEASE consider attending, as THERE'S A LOT AT STAKE THIS YEAR, from countering the threat to compounded hormones, to addressing the unrealistic ambiguity in FDA's animal compounding GFI, to educating Congress about how compounders can help fix drug shortage and supply chain issues.


We've never needed you more—joining us in DC for a mere 18 hours—it's a QUICK TRIP—for meeting with your members of Congress and protecting pharmacy compounding and the patients you serve.


But don't wait too much longer, as the APC room block at the Hilton National Mall is filling up fast, and there’s no overflow hotel.


The sooner you register, the earlier and better chance we have of scheduling you for an in-person visit with your members of Congress. (Note: Due to scheduling deadlines, Hill visit requests are not guaranteed for any registrations received after August 26, 2022.)


Find full details, get registered, and make your hotel reservation here.

Carter, Harshbarger request GFI 256 enforcement delay

In a letter last week to FDA Center for Veterinary Medicine Director Dr. Steven Solomon, Congressman Buddy Carter (GA) and Congresswoman Diana Harshbarger (TN) respectfully requested that CVM and FDA delay enforcement of GFI #256 until at least FY2024, and continue to work with pharmacy and veterinarian stakeholders, including state regulatory agencies, to provide clarification as to how the guidance will be implemented and enforced.


The authors explained that the ability of many veterinarians and pharmacists to serve animal patients will be affected by this GFI, and there remain too many unanswered questions for pharmacy compounders and veterinarians to achieve compliance in such a short time.


Click here to read the full letter.

071922_Quality-Compliance-Webinar_APC-eNewsletter_600x335 image

cBHT emergency briefing: Three big asks

Yesterday, APC’s cBHT Campaign Steering Committee hosted an emergency briefing for APC members and compounding supporters and made three urgent asks of APC members and supporters to help ensure our patients can continue to have access to cBHT:


Stay tuned for a video recording of yesterday's briefing.

 
8 image

Notice of APC Annual Meeting

As required under its Bylaws, the 2022 annual meeting of the Alliance for Pharmacy Compounding will be held on Wednesday, September 14, 2:00-2:30pm, at the Hilton National Mall in Washington, DC, in conjunction with the Compounders on Capitol Hill (CCH) conference. Board Chair Michael Blaire of Scottsdale, Arizona, will preside.


No registration is required to attend the annual meeting; however, registration is required to attend any other CCH events.

WB_LP3-APC_Aug-Webinar_Hazardous-Decontamination-TABLET-FINAL image
 

Save these dates

August 16, October 6: A joint APC/PCCA program, Quality & Compliance Webinar


August 18: An APC Webinar: Hazardous Drug Decontamination – Understanding its Purpose and Validating Best Practices with Abby Roth


August 18–19: A joint APC/PCCA, in-person program, USP Implementation Training, Houston, TX


August 23, 2022: APC and Pharmacy Compounding Foundation call for board nominations ends


August 30: FDLI Drug Compounding Webinar, Updates and Developments in Drug Compounding


September 6–8: FDA's virtual Compounding Quality Center of Excellence Annual Conference


September 14: APC's Annual Meeting during Compounders on Capitol Hill, 2:00-2:30pm ET, Hilton National Mall, Washington, DC


September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC


September 22: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART I - PROVIDERS AND PRESCRIPTIONS (registration link coming soon)


October 13: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART II - WHOLESALE DISTRIBUTORS (registration link coming soon)


October 26–29: PCCA's International Seminar, Houston, TX (in-person + virtual)

071922_USP_APC-eNewsletter_600x335 image
 

Short takes

Congratulations to Empower Pharmacy CEO + Founder Shaun Noorian, who was recently named to the Houston Business Journal’s "2022 Most Admired CEO Awards." Shaun and the other 44 honorees will be recognized at an in-person awards luncheon on September 1. Full story here.


Fun DC fact: There's a miniature version of the Washington Monument hidden inside a manhole cover near the full-sized one. Be sure to check it out during Compounders on Capitol Hill next month. #CCH2022

 
CC-CompPAC-Ad image
 
 

Quick links



APC Career Center

• Job seekers

• Employers


APC's Code of Ethics


Compounding Connections archive


Compounders on Capitol Hill 2022


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

   


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

  

Facebook  Twitter  Instagram  LinkedIn

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.