APC News

MEMBER ALERT: Compounding “essentially a copy” of an FDA-approved drug

Published May 5, 2023

Three state boards of pharmacy recently issued licensee communications that contained incorrect information about FDA guidance on shortage drug compounding by 503A pharmacies.

State-by-state USP 800 doc updated

Published May 5, 2023

We have updated our USP state-by-state implementation tracking spreadsheet, and it’s available online here—but only to APC members. This resource shows the status of implementation of USP 795, 797, and 800 chapters in every state.

FDA clarifies position on compounding semaglutide sodium

Published April 28, 2023

In a letter sent this week to NABP, FDA clarified its position on the compounding of semaglutide sodium.

Share this with your prescribers: The threat to compounded hormone therapy affects them, too

Published April 28, 2023

Help us help prescribers understand the importance of preserving compounded hormone therapy.

Another NASEM conflict of interest

Published April 28, 2023

A recent article revealed that the National Academies of Science, Engineering and Medicine reportedly received funds—to the tune of $19 million—from members of the Sackler family.

Such a lovely place: California board rejects further changes to proposals

Published April 21, 2023

The California Board of Pharmacy met yesterday to discuss proposed regulations on non-sterile, sterile, and hazardous compounding.

Pharmacy owners: You’re gonna need this bucket

Published April 21, 2023

Looking for a way to enhance your compounding pharmacy or facility's capabilities, keep your team up-to-date on industry developments, and connect with fellow compounding professionals? 

Hey CVM, we have a few more questions…

Published April 21, 2023

APC this week asked FDA’s Center for Veterinary Medicine to provide additional guidance on compliance with its GFI 256 on animal drug compounding.

APC to Tennessee BOP: Where’s the benefit?

Published April 14, 2023

APC this week wrote to the Tennessee Board of Pharmacy to express concern that the board has not shown evidence that two proposed compounding-related regulations will improve patient safety.

APC to California BOP: How do proposals protect patients?

Published April 14, 2023

APC this week submitted a comment letter expressing concern over the California Board of Pharmacy's proposed changes to regulations related to sterile compounding.

APC to Montana legislators: Please reconsider

Published April 14, 2023

This week APC sent a comment letter to the Montana Senate Business, Labor, and Economic Affairs Committee considering HB 152, which recently passed the Montana house.

Makena withdrawal creates confusion for compounders

Published April 14, 2023

The recent withdrawal of Makena by the FDA has created complications for pharmacy compounders, particularly regarding the use of hydroxyprogesterone.

Are you an IJPC subscriber?

Published April 14, 2023

The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly scientific and professional journal for conscientious compounding pharmacists.

Help your small business rise…

Published April 14, 2023

Small Business Rising is a grassroots organization advocating for policies that support small businesses. Compounding pharmacy owners can join their mailing list to stay informed about relevant legislation and advocacy efforts.

APC sets record straight on “essential copies” in animal compounding

Published April 7, 2023

In a letter sent this week to FDA’s Center for Veterinary Medicine, APC corrected misleading input provided to the agency in a February comment letter from the Animal Health Institute and Generic Animal Drug Alliance.

Apply to be a 2023 APC Fellow

Published April 7, 2023

We’re calling for nominations for the 2023 APC Fellows Program. This program recognizes the distinguished contributions made by compounding pharmacist and pharmacy technician members to the profession and their communities.

Quinacrine hydrochloride added to 503B bulks list

Published April 7, 2023

FDA has added quinacrine hydrochloride to its list of bulk drug substances that can be used in compounding by outsourcing facilities...

Missed our GFI 256 compliance webinar? Now watch it on-demand

Published April 6, 2023

Find out what you need to know about GFI 256 by purchasing access to the recent GFI 256 compliance webinar, sponsored by APC and PCCA. It’s now available on-demand until June 15 for $25 (no CE credit).

A short story of persistence and potential

Published March 31, 2023

APC members Stuart Johnson and his wife Brandi, of Aiken, SC, didn’t know their US Senator Tim Scott, but they signed up to meet with his staffer last September during Compounders on Capitol Hill.

Harshbarger, Carter question CVM leader

Published March 31, 2023

Yesterday, the House Energy and Commerce Committee's Health Subcommittee held a hearing on reauthorizing the animal drug user fee...

Owner Summit is done: See you in 2024!

Published March 31, 2023

Earlier this week, APC hosted its third annual Owner Summit in Point Clear, Alabama.

Racehorses, compounding and confusion

Published March 24, 2023

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.

Coming soon: Compounding certificate program for your new hires

Published March 24, 2023

Later this spring, we’ll be debuting a new 15-hour certificate program, “The Ethical, Legal, and Regulatory Framework of Pharmacy Compounding.”

California BOP compounding proposals out of sync with national standards

Published March 24, 2023

The California Board of Pharmacy’s Enforcement and Compounding Committee met yesterday to discuss proposed regulations related to sterile compounding.

March policy video: Here’s what’s happening

Published March 24, 2023

Check out the latest public policy update video from APC Director of Public Policy Savannah Cunningham, PharmD.

GFI 256 enforcement starts April 1. Is your pharmacy ready? Our 3/22 webinar can help…

Published March 20, 2023

In advance of the April 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance.

CVM issues Letter to Industry on GFI 256 phase-in

Published March 17, 2023

In response to a request from APC and NCPA, FDA’s Center for Veterinary Medicine last week issued a Letter to Industry explaining the phased-in approach to enforcement the agency plans to take on GFI 256. 

Explain yourself to prescribers

Published March 17, 2023

The Prescriber Briefs developed by APC and the Pharmacy Compounding Foundation are excellent resources for educating prescribers about pharmacy compounding—including laws, guidance, and standards you must adhere to.

Extended: APC Fellows application date (now June 1)

Published March 17, 2023

Since the program’s inception, 112 pharmacists have been nominated to this elite group. Thirteen new members were inducted during last year's Compounders on Capitol Hill.

OPEN TO ALL COMPOUNDERS: GFI 256 compliance webinar

Published March 10, 2023

In advance of the Apr 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance.

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