From APC's President

Are you putting yourself at risk with the DEA?

How are your prescribers legally required to sign their prescriptions, especially controlled substance prescriptions? The answer might seem obvious. After all, we’ve been filling prescriptions our entire careers; we know this stuff. 

Maybe you’ve heard the idea of pharmacies providing prescribers prescriptions for controlled substances that the prescriber can sign via Docusign. While this seems like an easy way to receive a valid prescription, DEA, in particular, may not be keeping up with technology as you and your prescribers are, and the agency is not on board with the advent of DocuSign and the like.

Forget about your state’s pharmacy law for the moment and whether this is legal or not (which it’s probably not because state Boards of Pharmacy have not yet met to promulgate these rules). What’s certain is that it is absolutely illegal under federal law.

Basically it boils down to this: Either the prescription needs to be hand-signed by the prescriber with an ink pen, or the rx must sent to the pharmacy in a manner that satisfies the DEA’s Electronic Prescribing of Controlled Substances (EPCS) standards. In addition, the DEA prohibits prescribers from simply signing “pre-printed” prescriptions. 

The DEA’s “wet signature” requirements may be found in two relevant sections of the Code of Federal Regulations (“CFR”): 21 CFR 1311.120 and 21 CFR 1311.115. They are also referred to as the “EPCS rules”, or “electronic prescriptions for controlled substances.” The rules are designed to ensure that prescribers of controlled substances are who they say they are and that someone can’t forge a prescription (like an office worker).

Put simply, prescribers must use two forms of authentication to electronically sign a prescription including things like a password and a biometric scan or something similar. Docusign documents only contain a single form of authentication: a password. This obviously violates EPCS rules.

Second, under the Federal Controlled Substances Act and DEA regulations, there may be limitations as to whether pre-printed prescription pads can be used for controlled substances. 

According to a DEA opinion letter cited in a 2014 legal memo, pharmacies cannot prepopulate prescriptions with patient names for controlled substances. Certain State Boards of Pharmacy have interpreted this to mean that prescriptions with controlled substances pre-printed on them are prohibited, even if the prescription does not have any patient demographics on it.¹

So while it might seem like a great marketing idea to send your prescribers prescriptions containing controlled substances via Docusign to make it easy for them, you are putting them and your practice at risk.

___________________________

¹ https://www.frierlevitt.com/articles/service/pharmacylaw/ensure-your-use-of-pre-printed-prescription-pads-is-compliant/

• • •

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

Free webinar: How GFI 256 will change your compounding practice

Maybe you’ve heard about FDA’s GFI 256, regarding animal compounding, and wondered if it might affect you. If you do animal compounding—any animal compounding at all—the answer is a firm “YES!”

FDA’s Center for Veterinary Medicine says it will begin enforcement October 1. Trouble is, there’s still so much ambiguity in the GFI that it’s difficult to know what compliance even looks like just yet, much less actually developing SOPs and coming into compliance by the deadline. Yes, we’ve asked CVM to delay enforcement for another year, but we’ve received no response yet to that request.

So: To help you figure out this hairball of a GFI, APC will host a free webinar for veterinary compounders on September 2 at 12pm EDT. We’ll discuss the what and why of the GFI, as best we understand it, and we’ll spotlight areas of concern that you need to be aware of as you bring your practice—and the veterinarians you work with—into compliance.

The event is free, but registration is required. Register here.

CCH is less than a month away

Having a hard justifying the time away from compounding to attend this year's Compounders on Capitol Hill? Well, here are five compelling reasons you should join us in DC next month:

• Patient advocacy: Meeting with your representative(s) on Capitol Hill is crucial to getting your voices heard. Note: For those asking about in-person vs. virtual meetings due to continued Covid precautions: APC is working with Advocacy Associates to schedule your CCH appointments. Advocacy Associates has reported they are seeing about a 70/30 split, with 70% being in-person.

• Engagement: On Wednesday afternoon (and for the first time ever) FDA's Acting Director, Office of Compounding Quality and Compliance Gail Bormel will join us for an educational discussion (no CE credits) with APC CEO Scott Brunner.

• Support for two of compounding's advocates in DC: Attend our CompPAC reception on the afternoon of September 14 with Rep. Cathy McMorris Rodgers (WA), Ranking Member, House Energy & Commerce Committee, then hear Senator Jackie Rosen (NV), member of Senate HELP Committee, speak at breakfast on Thursday morning, September 15.

• Quality time with your colleagues: Take a break from schmoozing and spend a couple hours cheering on the home team: Each registration includes one ticket to the Pharmacy Compounding Foundation Fundraiser: A Night at the Ballpark, generously sponsored by PCCA, Medisca, and Fagron.

• New ideas: Explore the wide variety of products and services offered by our 28 fabulous exhibitors during exhibit hours both days.

Find full details, get registered, and make your hotel reservation here.

Have you taken our GFI 256 survey?

As you read above, FDA plans to begin enforcement of the GFI on October 1, 2022. Compliance will mean that veterinary practices and compounding pharmacies will have to navigate through transformative changes in their policies, practices, and procedures.

We’re conducting a short, seven-minute survey of compounding pharmacies to help APC understand your readiness for compliance with the GFI #256.

Please click here to take the survey.

Dear Congress: Save compounded hormones!

3,222 folks have sent 9,370 cBHT messages to 269 members of Congress

You know that page at compounding.com where you can send to your members of Congress a message about FDA’s implicit threat to restrict compounded hormone therapy? (Nod your head yes.) 

Since the launch of our campaign to save compounded hormones last year, 3,222 individuals have sent 9,370 messages to 269 members of Congress, asking them to intervene and admonish FDA not to rely on the discredited NASEM report as a basis for restricting cBHT.

Those are some reasonably impressive numbers until you get to that 269 – since 269 is barely more than half of the 535 members of Congress.

It means that patients, prescribers, and pharmacists of about half the members of Congress have not yet sent messages. It means we have work to do.

PLEASE: Urge your compounded hormone patients and prescribers to go to compounding.com and send a message—ASAP!—to their members of Congress. It’s quick and easy—and their continued access to compounded hormone therapy may just depend on it.

Save these dates

August 23, 2022: Deadline for APC and Pharmacy Compounding Foundation board nominations

August 30: FDLI Drug Compounding Webinar, Updates and Developments in Drug Compounding

September 2: Free webinar: How GFI 256 will change your compounding practice

September 6–8: FDA's virtual Compounding Quality Center of Excellence Annual Conference

September 14: APC's Annual Meeting during Compounders on Capitol Hill, 2:00-2:30pm ET, Hilton National Mall, Washington, DC

September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC

September 22: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART I - PROVIDERS AND PRESCRIPTIONS (registration link coming soon)

October 13: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART II - WHOLESALE DISTRIBUTORS (registration link coming soon)

October 26–29: PCCA's International Seminar, Houston, TX (in-person + virtual)

Short takes

Inflation Reduction Act is official. Now what? Earlier this week President Biden signed the Inflation Reduction Act into law. Here's a quick summary from NCPA on how that impacts pharmacies.

The US Capitol Building has an empty crypt under the Rotunda. It was originally intended to be George Washington's final resting place, but his will instructed that his remains be interred at his home at Mount Vernon. Learn more about the US Capitol Building here and then register for Compounders on Capitol Hill, APC's annual fly-in to DC.

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill 2022

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

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

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.