APC: CC: May 27, 2022 issue

The voice for pharmacy compounding | May 27, 2022
 
From APC’s President
Insanitary subjectivity
As you’ll read below, APC recently filed an amicus brief on the side of an APC member pharmacy that was unfairly cited and threatened by the FDA. (I can hear your collective gasp, because we all know the agency would never do that! 😂)
 
In short, FDA was demanding that the pharmacy recall all of its non-sterile products because of “insanitary conditions.” Trouble was, what the agency was calling insanitary was completely subjective.
 
Now let me be very clear: Maintaining sanitary conditions is extraordinarily important. But so is having a definitive standard rooted in science and law. FDA seems to be taking the position that insanitary conditions are sort of like pornography: They know it when they see it. But that’s no way to regulate compounders, who deserve to have bright line definitions for maintaining compliance.
 
Another issue here is the agency’s strong-arming of compounders through threats and intimidation and without the benefit of due process or even sharing the details behind the rational for the strong-arming. The FDA can basically destroy a pharmacy’s reputation by issuing a press release that alleges insanitary conditions—and pharmacies know this, so they usually capitulate. But that’s not what happened this time, and compounders nationwide are the beneficiaries.
 
Thanks to Karla Palmer of Hyman, Phelps & McNamara, whom we engaged to write our amicus brief in this matter. And thanks to those of you who have contributed to APC’s Legal Action Fund, because that’s how we funded that legal brief.
 
Read on for details. I think you’ll be impressed—and glad that you’re a member of APC!

• • •
 
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.
This week
APC amicus brief addresses ambiguity in FDA insanitary conditions guidance
On May 13, APC filed a “friend of the court” brief with the U.S. District Court in New Jersey pointing out ambiguity in FDA’s “insanitary conditions” guidance.
 
Funded by member contributions to the APC’s Legal Action Fund, the amicus brief was authorized in response to an urgent request from Wedgewood Pharmacy asking APC to support its filing for a temporary restraining order against FDA. (Read the complete background on what happened here.)
APC engaged in the matter because we were—and remain—concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be the vague, subjective disciplinary standard suffered by Wedgewood.  
In particular, FDA derives its enforcement authority from a non-binding guidance document that contains not any objective standards, but instead relies on what appears to be a bunch of examples and the nebulous statement that “other conditions not described in the guidance may also be considered unsanitary.” How is a compounder to know what is in fact violative conduct?
 
While APC strongly supports the maintenance of sanitary workspaces where compounded drugs are prepared—it’s simply essential for assuring patient safety—there must be standards for what constitute “insanitary conditions,” and those standards need to be rooted in science and the law.
 
APC is proud of our involvement in this matter: it is another way we’re looking out for you. If you’d like to fuel our ability to be involved in other legal cases related to pharmacy compounding, please consider contributing to APC’s Legal Action Fund.
A word from our sponsor: PCCA
Get in the know with The PCCA Blog—your free online destination for content on a wide variety of subjects, including, “Understanding the Different Alcohols Used in Pharmacy Compounding.”
 
In this recent post, PCCA Formulation Development team members provide definitions and differentiating factors regarding the various alcohols used in pharmacy compounding. Read and subscribe to The PCCA Blog at pccarx.com/blog.
USP 800 work group aims to assist BOPs
A new APC workgroup is charged with developing guidance to help state boards of pharmacy interpret, implement and enforce USP 800. USP 800 provides guidelines for safe handling of hazardous drugs to minimize the risk of exposure for healthcare personnel, patients and the environment.
 
Chaired by Matt Martin, the group met for the first time this week to plan its work. The workgroup includes Cheri Kraemer; Jon Pritchett; Rad Dillon; John Herr; John Kim; Dave Rochefort; Kathleen Kane; and incoming APC Director of Public Policy Savannah Cunningham.
 
“We hope to provide boards of pharmacy thoughtful considerations about areas of USP 800 that have created significant discussion and/or concern for both pharmacists and some boards of pharmacy,” Martin said. “This USP chapter and its implementation will have a significant impact on patient access, the cost of healthcare and how healthcare is delivered across all disciplines of medicine based on how compliance is carried out. It is important that substantive discussions around the implementation of this chapter occur.”
 
The workgroup hopes to make its guidance resource available to boards of pharmacy in fall 2022.
On Thursday, June 9, APC’s CompPAC will host a 45-minute virtual Town Hall with Chris Schiller, an Oklahoma pharmacist and APC member who is running for US Congress. Learn about Chris’ election prospects and the kind of help he needs to win.
 
Please join us—and invite your fellow pharmacy team members. Here are the Town Hall details:
 
Together we can send another compounding champion to Congress to fight for your patients and your small business.
Save these dates
Short takes
Reporting a problem but not a solution: CBS’s 60 Minutes news program last week covered the ongoing issue of drug shortages in hospitals and clinics. Alas, no mention of how pharmacy compounding could help resolve the problem. Yes, we’ve reached out to CBS.
 
New tool facilitates complaints to state departments of insurance: Earlier this week, NCPA launched a new resource to help pharmacists and patients report possible violations to state insurance regulators and push them to enforce state laws regarding PBMs.
 
To end on a good note…It’s a long, holiday weekend and the unofficial start of summer. Get your grill ready for business the safe and smart way.
 
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.