2018 Farm Bill, Technician Ratios, and Hazardous Waste Rules: Hot Topics in Pharmacy Law
Health & Life Sciences Alert 08/19/19 Anne M. O'Brien, Nicholas H. Meza, Jacqueline M. Vidmar
Some of the hottest topics in pharmacy law, as discussed at Quarles & Brady’s 2019 Pharmacy Law Symposium in Chicago, are wide-ranging and subject to great change in the next year.
Leading off the program were Quarles & Brady attorneys Anne M. O’Brien, Nicholas H. Meza, and Jacqueline M. Vidmar, who each had up-to-the-moment takes on some of the most pressing issues in pharmacy law today.
2018 Farm Bill and CBD
O’Brien started off the discussion by discussing the 2018 Farm Bill and its impact on the regulation of CBD in the past year. She provided an overview of cannabinoids, the different types (THC, CBD), and how the landscape has evolved since the 2014 Farm Bill, which gave states discretion to adopt regulations governing hemp production.
The 2018 Farm Bill expanded the definition of "industrial hemp," removing the qualifier "industrial," and including hemp derivatives, extracts, and cannabinoids. The latest bill also explicitly removes hemp from the Controlled Substances Act by excluding it from the definition of marijuana, removes the requirement that hemp only be grown as part of a pilot program designed to study aspects of the hemp industry, and explicitly permits interstate transport of hemp.
“There is a bit of a gray area,” O’Brien said. “It’s very clear that hemp cultivated under the 2014 regulatory framework can be currently transported interstate. The USDA came out with a legal opinion in May which stated that until they promulgate regulations, which they say that they will do by the end of 2019, the expanded hemp production allowed under 2018 Farm Bill cannot be transported interstate.”
The FDA retains regulatory oversight of CBD for food and drug uses. Looking forward, the FDA is considering permitting use in foods or supplements, and changes are likely. Due to recent changes in agency leadership, it is an open question whether the FDA would exercise enforcement discretion if no treatment claims are made.
Technician Ratios for Nonresident Pharmacies
Later, Meza began with a story about technician to pharmacist ratios in Alabama for nonresident pharmacies.
“There have been a number of changes in the last few months,” Meza said. “Not only changes in the laws, but changes in interpretation.”
In early 2019, Meza said, the Alabama Board of Pharmacy sent out letters telling nonresident pharmacies that were renewal applicants that the ratio stated on their application was too high and not in compliance with Alabama law. The Alabama law states that “three technicians, one of which shall be certified by any credentialing organization approved by the Board, on duty are sufficient in the prescription area of a retail pharmacy or an institutional pharmacy for each full-time licensed pharmacist on duty.”
Within 14 days, pharmacies that received the letter were required to respond in writing with supporting documentation that their facility was compliant with Alabama's ratio. Alabama’s stated position is: “As a condition of receiving a permit, the nonresident pharmacy or a renewal applicant must comply with…all applicable statutory provisions and rules.” However, Meza explained that there was no clear nexus between the Board's interpretation and a plain reading of the nonresident pharmacy rule.
“The Board would say, ‘these rules have been on the books,’” Meza said. “And so, they are just enforcing existing rules. [But] I know a number of pharmacies that were caught off guard by the Board's position, especially when they have been operating with a ratio greater than 3:1.”
So, what’s next in Alabama? Given the mixed industry reaction, pharmacies may begin to challenge the Board of Pharmacy’s interpretation, review functions being performed by technicians or make changes to their staff or even their operations.
Just recently, the Alabama Board of Pharmacy filed a Notice of Intended Action/Rulemaking to ensure technician oversight has the same standards for nonresident as it is for resident pharmacies—comments are due August 19, 2019.
Changes to Pharmaceutical Hazardous Waste Rules
To conclude the panel, Vidmar discussed the new federal management standards for pharmaceutical waste under the Resource Conservation and Recovery Act (RCRA). New Subpart P creates sector-specific standards for health care facilities (HCFs) and reverse distributors. These standards, not the general RCRA rules, will apply to pharmaceutical hazardous waste generated by these entities.
Subpart P does not apply to pharmaceuticals that are legitimately used/reused or reclaimed, and while the EPA states that pharmaceuticals going through reverse distribution are considered waste at the HCFs, special consideration for their unique status is reflected in what is required by the management standards.
Subpart P includes a sewering ban; health care facilities and reverse distributors cannot discharge hazardous waste pharmaceuticals "to a sewer system that passes through to a publicly owned treatment works." The sewering ban is effective in all states and territories on August 21, 2019, applies even to very small quantity generators operating under a different part of RCRA. Non-hazardous pharmaceuticals are exempt from the ban, but the EPA strongly discourages sewer disposal of all pharmaceuticals.
The changes to RCRA also include a nicotine listing amendment; FDA-approved nicotine-replacement therapies will no longer be included under the P075 listing for hazardous waste, even though nicotine itself is still listed as acute hazardous waste.
Vidmar listed next steps to take in the short-term, including assessing the current state of RCRA compliance, including hazardous waste determinations, and monitoring state adoption of Part 266, noting variations and compliance deadlines. The management standards are effective in "non-authorized" states on August 21, 2019 (Iowa, Alaska, Indian Country, and US Territories [except Guam]), and "authorized" states are required to adopt the standards by July 1, 2021 (or a year later if a statutory amendment is required).
“There’s opportunity now to assess, and if necessary, talk to the EPA or legal counsel, to determine whether your procedures are compliant or what changes are necessary. As comprehensive as these regulations are, they’re not going to cover every situation. That’s where it gets tricky—understanding how the rules may affect your unique business practices.”
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