The voice for pharmacy compounding │ 16 June 2023

From APC's Chairman

Shooting straight

I’ll shoot straight with you: If your compounding job or practice or business is important to you (and I suspect it is), you need to plan to attend APC’s Compounders on Capitol Hill, set for September 19-20 in Washington, DC.


As you’ll read below, registration opened this week, and you’ll save money if you register by July 7. After that the price goes up. 

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Don’t put it off. Get registered now. (And don’t forget a hotel reservation. Our host hotel will fill up fast.)


Together, we’ll take back our profession from those who would marginalize us. See you there. 


Read on for this week’s news.

– 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

CCH early bird registration is OPEN

Attendee registration is now open for APC’s annual DC fly-in, Compounders on Capitol Hill, September 19-20.


This is your once-a-year opportunity to lobby lawmakers on their turf—and to make a big difference for our profession!


Be sure to take advantage of our early bird pricing $555 per person through July 7 (it’s even lower for Pharmacy/Facility Members: $455).

CLICK HERE TO REGISTER

While you're at it, be sure to book your hotel room at the Hilton National Mall The Wharf in Washington DC and get our special rate of $319/night single/double occupancy. The deadline for hotel reservations is Tuesday, August 29.


  • Call 1-800-Hiltons to make reservations with the code CCH23 to receive the group discounted rate.
  • Or, book your hotel room at a4pc.org/cchhotel.


Exhibitors, stay tuned for more details on your registration. Interested in being a CCH sponsor? Take a look at our 2023 CCH Prospectus.

Nevada legislature reverses state’s BOP mandate

Assembly Bill 107, enacted by the Nevada Legislature on May 31, 2023, reversed a previous interpretation by the Nevada Board of Pharmacy that mandated out-of-state pharmacists to obtain a Nevada pharmacist license when dispensing or compounding prescriptions for Nevada patients.


The bill—which takes effect on October 1, 2023—now clarifies that not every out-of-state pharmacist who dispenses or compounds prescriptions for Nevada patients requires a Nevada licensure. Instead, non-resident pharmacies must provide the name of at least one registered pharmacist practicing at the pharmacy, who will assume responsibility for prescriptions dispensed to Nevada patients and any actions or omissions of unregistered pharmacy personnel.

FDA: Know your bulks and excipients suppliers

Earlier this week, FDA issued a new guidance to compounders, Know Your Bulks and Excipients Suppliers.


APC expresses support for NY bill. In the document, FDA reminds compounders that sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act contain provisions regarding bulk drug substances (APIs) use in compounding, including:


  • API compliance with applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph standards
  • Sourcing API from FDA-registered facilities, and valid certificates of analysis. 


The announcement also points out provisions regarding excipient compliance with applicable USP or NF monograph standards.

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Short takes

Heard of USP’s Medicine Supply Map? Neither had we until last week. It’s “an early-warning system for possible drug shortages" and helps enhance “visibility into the upstream medicines supply chain to help governments, manufacturers, distributors, and providers identify and address vulnerabilities, lessen quality risks, reduce the frequency and duration of potential drug shortages, and protect patients.” Intrigued? Give it a look


APC expresses support for NY bill. This week APC submitted a comment letter to the New York Assembly Higher Education Committee regarding State Senate Bill 2314, which allows compounding for veterinary office stock that is currently not permitted in the state. In the letter, APC expressed support for SB 2314.


Scientists are making babies. Well, kinda. It was recently reported that synthetic, human-like embryos are being developed through a joint US-UK research study. The article thankfully acknowledges that the existing and potential legal and ethical concerns are thick on this one even though the embryos don’t have hearts or brains. 


Next Covid-19 booster is in the works. Confirming that the virus is going to be an ongoing threat, FDA advisers met this week to determine which strain (or strains) the fall-issued booster Covid shot should target.

Save these dates

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


June 27: An ARL live webinar, Rapid Sterility Testing: An Alternative Microbiological Method, 12pm CST, free


June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know


July 19: An APC webinar, Leveraging Technicians to Improve Pharmacy Operations, 2pm - 3pm ET.


August 17-18: Informa Connect's Compounding Pharmacy Compliance, The Westin Copley Place, Boston, MA


September 11-13: FDA's Compounding Quality Center of Excellence Annual Conference (free, virtual)


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


2024

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

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.