Eight members of Congress wrote to FDA Center for Veterinary Medicine director Dr. Steven Solomon this week to express concern that CVM’s GFI 256 on animal compounding may result in delayed care for veterinary patients. read more →
Several changes to NABP’s new Model Act were recommended by APC, including a requirement that licensed compounding pharmacies provide to the state board of pharmacy basic information about their compounding operations. read more →
One hundred members of Congress signed a letter of concern sent last week to the Department of Defense in response to recent TRICARE changes that threaten beneficiaries’ access to community pharmacies, especially in rural areas. read more →
In a Sep 16 letter to NABP CEO Al Carter, FDA states that DTE products “can put patients at harm” and that “therapies containing DTE are biological products subject to licensure under Section 351(i) of the PHS Act.” read more →
One result of last week’s Compounders on Capitol Hill visits has been the creation of a joint congressional letter to FDA’s Center for Veterinary Medicine raising concerns about the great ambiguity in GFI 256 on animal compounding read more →
The voice for pharmacy compounding | March 18, 2022
➤ From APC’s President
SWOT, Part 5
David J. Miller, RPh
Last week, I addressed APC’s opportunities — including membership, Tricare, FDA and technicians.
The “T” in SWOT stands for threats.
APC and pharmacy compounding have always faced threats, small and large. FDA overreach is an ongoing fight and probably the greatest threat we face; the agency just seems to become ever emboldened in its efforts to marginalize our profession.
“FDA believes the results of NASEM’s research provide important information that will increase public understanding regarding cBHRT products. When developing agency policies, FDA intends to consider the information in the NASEM report, along with information and comments received from members of the public, while taking into account patient access concerns.”
FDA sticking with that debunked report isn’t a surprise — but now there are rumors that it could move to put hormones on the “demonstrably difficult to compound” list as early as this summer. We all know that hormones are not difficult to compound; three-quarters of APC members do it regularly, and they rely on compounded hormones as a clinical and business line. Without cBHT, many of us would cease to exist as compounders.
(And don’t forget that FDA also commissioned a NASEM report on compounded topical pain therapies. If it’s successful with limiting cBHT, you can bet it will take similar action on those.)
These threats doesn’t apply only to humans. In its Guidance for Industry #256 the agency shows its intent to meddling in the practice of veterinary medicine — prohibiting compounding for animals from pure ingredients in most circumstances.
These are threats, but they’re also opportunities. And that’s why I’ve stressed increasing our membership, strengthening CompPAC, and working with agencies like FDA. Please help.
David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at firstname.lastname@example.org.
➤ This Week
HealNow is APC’s preferred online payments platform
APC is pleased to announce our new affinity relationship with HealNow — our preferred online payments platform for compounding pharmacies.
HealNow allows consumers to engage with their pharmacy online: to make co-payments, schedule delivery, purchase OTC items/supplements, and get answers to clinical (and non-clinical) questions, all in one easy swoop from any device. And thanks to this new relationship, APC members will be able to save money when using HealNow.
HealNow lets you offer your patients and customers the kinds of online services that CVS, PillPack, and other digital pharmacies offer theirs.
It makes the move to full-service digital a lot easier. HealNow does all the heavy lifting — pharmacies don’t need to pay thousands of dollars to a third-party credentialing organization or spend months finding a payment processor that accepts online payments. With HealNow, your pharmacy can accept online payments in hours.
Check out what going all-in with digital can do for your pharmacy, and how HealNow can make it happen: HealNow.co. And when you sign up, be sure to tell them you’re an APC member!
APC to USP: “Where’s the science?”
APC submitted formal comments this week regarding USP’s proposed changes to beyond-use dates in General Chapters <795> and <797>.
The detailed, 92-page document, largely formulated by APC’s BUD Task Force, not only laid out in detail our comments on the language of the proposals, but provided the rationale behind each change we believe must be made.
Most notably, we strongly urged USP to remove any references to batch size restrictions:
APC requests that USP remove any batch-size limits for CSPs and allow Category 3 CSPs to be assigned BUDs of up to one year, regardless of sterilization method or storage temperatures, as supported by data from stability-indicating studies, until USP can:
Demonstrate that its proposed batch-size limitation and BUD restrictions are rooted in objective, replicable science and provide clear patient benefit; and
Provide guidance as to stakeholder concerns over the effects of colder storage temperatures on compounded preparations, packaging, and patients themselves and the effects on patient access of cost-prohibitive stability studies
Corporate Patrons give big to help save cBHT
In the past week, APC received major contributions from two of our Corporate Patrons to the Campaign to Save Compounded Hormones.
We hope you’ll support these companies the way they’re supporting compounding — and, of course, support the campaign!
APC weighs in with Arkansas BOP
The Arkansas State Board of Pharmacy is considering an allowance for veterinary office stock, and asked for stakeholder input. The question: “Is retail pharmacy compounding for veterinary office stock (also referred to as office-use) allowed in the absence of a patient-specific prescription?”
APC responded with a letter asserting that yes, “compounding for veterinary office-use is expressly allowed under state law, and neither federal law nor regulations address animal drug compounding.”