The voice for pharmacy compounding │ 12 May 2023

This edition is sponsored by Medisca

From APC's Chairman

Pay attention!

It’s hard to pay attention to every email that lands in your inbox, but I’m asking you to look for and respond to one we’ll be sending you this coming Tuesday. 


It will be an urgent call to actiona request for you to reach out to your members of Congress within 48 hours.


What’s the ask? 

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You want them to take a look at our urgent-use/shortage drug compounding legislation. In the House that’s HR 167, for which we’re seeking additional co-sponsors. In the Senate, it’s the language of that House bill, which we’re looking to have added to the pandemic preparedness reauthorization bill taking shape in the Senate HELP Committee.


The legislation would make the 2020 temporary guidance on compounding COVID drugs permanent and would expand it to include any drugs that are listed as “currently in shortage” on the FDA’s drug shortage list. It would allow traditional compounders to prepare shortage drugs not only for hospitals but also for medical clinics if they cannot source needed drugs for in-clinic administration—say, for a cataract surgery—from the manufacturer or an outsourcing facility.  


It would also require that FDA’s Drug Shortage list be supplemented by the drug shortage list maintained by the American Society of Health System Pharmacists, which is a better real-time indicator of national and regional drug shortages.


We’re making reaching out to your legislators quick and easythe punch of just a button or two. We’ve pre-written the message for you, though you can certainly personalize it if you wish. And we’re using a platform that, based on your home address, will send the message to your members of Congress even if you don’t know exactly who they are or how to reach them.  


It’s important for you to respond, so I’m giving you a heads-up: Pay attention to this one. Please.


– Anthony


Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at agrzib@wedgewoodpharmacy.com.

ICYMI

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

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This week

Medisca will match investments in ‘Compounding Joy’ campaign

Starting today, Medisca is supporting APC's “Compounding the Joy of Living” campaign by matching all individual contributions, dollar for dollar, up to $100,000.


That means just what you think: Every dollar you give will be worth two dollars to the campaign. With your support, we have the potential to add $200,000 to the fund just by working together!


For added convenience, you can now make small contributions of $5, $10, or $15 each time you place an order online with Medisca.


If you haven't invested yet, there is no better time to help us reach our $750,000 goal. Your support is vital for preserving access to compounded hormone therapy. Join us in securing patient access to compounded medications and let's give back to the joy of living.

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Califf positive on permanent urgent-use compounding fix

Responding to a question from Congresswoman Diana Harshbarger (TN) during a recent Energy & Commerce Health Subcommittee Hearing on "Preparing for and Responding to Future Public Health Security Threats," FDA Commissioner Dr. Robert Califf acknowledged the importance of compounding for addressing drug shortages during emergencies.


He also indicated that a permanent solution or guidance on the flexibility of compounding pharmacies could be a good thing to work on.


Additionally, Rep. Harshbarger questioned whether the FDA's shortage list accurately captures regional and wholesale level shortages. Dr. Califf agreed that the current system is subjective and could be improved, particularly in understanding the total distribution system. The possibility of recognizing the American Society of Health System pharmacist shortage listing was also raised, with Dr. Califf stating that everything is on the table for consideration.


We are very grateful to Rep. Harshbarger (who is also an APC member) for raising these issues for discussion.

New Prescriber Brief:

Compounding for racehorses

The latest in APC’s suite of briefing documents for prescribers is available. It’s titled "Compounding for Racehorses: An Overview for Veterinarians," and it summarizes regulation governing the use of compounded medications for racehorses.


Horseracing is a tightly regulated sport and has specific rules and regulations regarding the use of drugs in horses. The new anti-doping and medication control program launched by the Horseracing Integrity and Safety Authority in March 2023 addresses the use of banned and non-approved substances in horseracing. Howevercontrary to persistent rumorcompounded medications are not prohibited under the program.

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The HISA ruleand our prescriber briefemphasizes that veterinarians can continue to rely on compounding pharmacies to provide medications for their racehorses provided compounding pharmacies comply with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and FDA GFI #256 (Compounding Animal Drugs from Bulk Drug Substances).

 

APC’s prescriber briefs are a members-only resource. You’ll need your APC login and password to access them.

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Tennessee BOP heeds APC's recommendations

In response to a comment letter that APC sent to the Tennessee Board of Pharmacy regarding concerns about proposed rules that would require all personnel who compounded a product to be listed on the prescription label, the Board voted at its May 8 hearing to strike this language from the rules, removing this potentially burdensome change. 

Save these dates

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


May 16-17: PCCA ACT Legislative Conference, Washington DC


May 25: An APC webinar, IV Nutrition in Compounding


June 1: APC and OutcomeMD Express Lunch & Learn for Existing Users


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

SCPhA publishes compounding policy piece. An update on compounding public policy priorities by APC Director of Public Policy Savannah Cunningham appears in the April issue of South Carolina Pharmacy Association’s The Palmetto Pharmacist.

PTCB adds certificate program. The Pharmacy Technician Certification Board has announced the launch of its Nonsterile Compounding Certificate program. This new, specialized credential complements the organization's Certified Compounded Sterile Preparation Technician (CSPT) Program, which assesses technicians' knowledge and skills to prepare medications in sterile environments such as hospitals, home infusions centers, and other compounding facilities to prevent contamination.


Americans trust retail pharmacies, medical providers for health information. According to a recent Morning Consult survey, Americans put a higher level of trust for health news from retail pharmacies than they do from the White House and insurance companies.


FDA issues final guidance. FDA has announced the availability of an immediately-in-effect final guidance, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol. This guidance replaces the one issued in 2007. In addition to advice on compliance with applicable regulation, it also outlines recommendations to help pharmaceutical manufacturers, repackers, other suppliers of high-risk drug components, and compounders prevent the use of drug components contaminated with diethylene glycol and ethylene glycol.

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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  

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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.