The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to “revoke the exempted prescription product status for all butalbital products previously granted exemptions.”

If finalized as proposed, the significant impact of this change will be felt throughout the pharmaceutical supply chain.

The Controlled Substances Act and DEA’s regulations provide the agency with authority to exempt a prescription drug product containing a controlled substance from regulatory requirements and administrative, civil, and criminal sanctions.  DEA is authorized, among other reasons, to exempt nonnarcotic prescription drug products from application of all or any part of the CSA if the product also contains one or more active ingredients which are not controlled substances and in such quantities “as to vitiate the potential for abuse.“

The current list of Exempt Prescription Products (“EPP”) can be found here.

Butalbital prescription products, specifically those containing sufficient “quant[ities] of acetaminophen in the formulation, which was believed at the time to vitiate the potential for abuse[,]” have long been the poster child of the EPP (as opposed to the butalbital products containing caffeine and aspirin, which DEA has refused to exempt over the years). DEA states that there are 189 products on the EPP list that contain butalbital. This is slightly less than half of all the products on the list. DEA believes that all but 49 of the 189 butalbital products on the EPP have been discontinued. The NPRM also indicates that butalbital/acetaminophen products have enjoyed exempted status going back to 1967.

That is all about to change.

According to the NPRM, the agency

“has observed a pattern of diversion, online distribution, and abuse of exempted butalbital products. In particular, DEA has observed exploitation of the exempted prescription product status of butalbital combination products to enable abuse. Therefore, because the inclusion of acetaminophen has not vitiated the abuse potential of these products, DEA has concluded that these products do not meet the exemption criteria found in 21 U.S.C. 811(g)(3)(A).”

Specifically, DEA notes an increase in the illegal sale of these products over the Internet. In support of the NPRM, DEA also reminds us that at least 15 states treat all products containing butalbital as Schedule III controlled substances.

What does all of this mean for the pharmaceutical supply chain if the proposed rule is finalized? Here are a few areas for industry to noodle on when considering whether to comment on this rule:

  • By removing the exempted status, DEA will have the Ryan Haight Act as a tool to combat the sale of these products via the Internet. Practitioners, in most circumstances, will have to conduct at least one in-person medical examination before prescribing butalbital products and online pharmacies “will be required to cease the sale and distribution of the products containing butalbital,” unless they are in compliance with the Ryan Haight Act;
  • All butalbital products will need to be properly labeled with the CIII designation;
  • A DEA registration will be required for anyone who manufactures, distributes, dispenses, etc., products containing butalbital;
  • DEA registrants will be required to store butalbital products as they would other Schedule III products, maintain complete and accurate records and inventories (including an initial inventory when the rule takes effect) of all butalbital products, and prescriptions for butalbital products would be required to comply with the CSA and DEA’s regulations; and
  • Distributors will be required to include all butalbital products in their respective suspicious order monitoring programs.

As this is just a proposed rule, the public still has an opportunity to impact what is included in the final rule.  Comments must be submitted on or before May 12, 2022.

On November 19, 2021, the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) “to allow the transfer of electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies for initial filling on a one-time basis.”

This proposed rule aligns with the regulatory guidance provided by DEA in October 2017, that specifically restricted the transfer of unfilled prescriptions for controlled substances to electronic prescriptions.

Continue Reading New DEA Regulation Addresses Transfers of Prescriptions

On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (the “Notice”) seeking the public’s help with understanding the “practice, industry, and state regulations of telepharmacy.”

As DEA acknowledges in the Notice, telepharmacy is not a term defined by the Controlled Substances Act or DEA’s regulations. The agency’s current understanding of telepharmacy is that it involves “the provision of pharmacist care by a remote pharmacist, through the use of telecommunications and other technologies, to a patient located at a dispensing site.” DEA further states that the dispensing site is usually a “brick and mortar remote site” or “self-service, automated machines.”

Continue Reading DEA Seeks Your Help with the Practice of Telepharmacy

When was the last time you went to an in-person conference? Well, it’s time. The American Society of Pharmacy Law is meeting in person (and virtually) this year in Summerlin, Nevada for its 32nd Annual Pharmacy Law Seminar. The team at ASPL has again gathered industry experts from around the country to provide guidance on managing pharmacy legal risk and compliance.

Summerlin, NV
November 4-7, 2021

Continue Reading Annual ASPL Pharmacy Law Seminar is Back and In Person

The 2021 Healthcare Distribution Alliance Distribution Management Conference and Expo is still on! Yes, it’s virtual, and if you are involved in pharmaceutical distribution, you will want to register for one of the industry’s “must-attend” healthcare supply chain management events.

2021 Distribution Management Virtual Conference and Expo
August 9 to 12, 2021

On Tuesday, August 10, I will again be serving on a virtual panel: Navigating the Controlled Substances Regulatory Landscape. My colleagues and I will address a broad range of initiatives and challenges faced by entities regulated by the Drug Enforcement Administration in their quest to use the statutory authorities available to them to avert the misuse of controlled substances.

Continue Reading In Pharmaceutical Distribution? Join Me Virtually at the Distribution Management Conference

The COVID pandemic notwithstanding, the Drug Enforcement Administration (DEA), Department of Justice and other federal and state agencies continue to actively pursue and prosecute pharmacies, pharmacists, doctors and others in the industry for violations of the Controlled Substance Act, False Claims Act and other controlled substance-related crimes.

I’ve compiled news reports on such cases from the last two months, confirming that prosecuting health care fraud and illegal distribution of controlled substances continues to be top of mind for law enforcement.

Continue Reading Active Prosecution Continues for Controlled Substance Violations

The Washington Post reports that the Biden Administration is preparing to pull back recent Health and Human Services (HHS) guidance designed to expand access to prescribing buprenorphine for opioid use disorders (OUD).

On January 14, 2021, HHS published Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder.  In a nutshell the guidelines eliminated certain X-waiver certification requirements, allowing any DEA-registered prescriber to issue buprenorphine prescriptions for medication-assisted treatment of OUDs.  The HHS notice does not reference any coordination with the Drug Enforcement Administration (DEA) and DEA has yet to publicly comment on this change. Continue Reading Not So Fast: Biden Expected to Halt Expansion of Buprenorphine Prescribing

As I was reviewing the public comments regarding the Drug Enforcement Administration’s (DEA’s) Notice of Proposed Rulemaking (NPRM) providing a much-needed update to the agency’s suspicious order regulations, I noticed a similar issue raised by multiple commenters.  Apart from the myriad of comments and requests seeking greater clarity from DEA on several definitions and provisions, there appears to remain a misunderstanding of using the 5% rule for distributions amongst practitioners.

Continue Reading Confusion Persists with the 5% Rule

More than four years ago, the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) was signed into law. CARA, among other things, includes provisions allowing for the partial filling of prescriptions for Schedule II controlled substances. On December 4, 2020, the Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) implementing the partial fill provisions of CARA. While DEA does include additional provisions in the NPRM “to address certain regulatory requirements not addressed by the CARA[,]” the agency appears to have neglected to fully address circumstances when a prescription for a Schedule II is partially filled. Continue Reading DEA Proposes Regulations for Partial Fills of C-IIs

Update: DEA has reopened the comment period for the proposed rulemaking from February 25, 2021, until March 29, 2021.

The Drug Enforcement Administration (DEA) published its long-awaited Notice of Proposed Rulemaking  (NPRM)  regarding suspicious orders of controlled substances. This will likely be the most heavily scrutinized rule issued by DEA this year. Registrants impacted by this rule should submit comments by March 29, 2021. Continue Reading DEA Creates Two-Option Framework for Reporting Suspicious Orders