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Recent Legislative Activity on Opioids, Compounding

Issue Brief

May 18, 2018

On May 16, 2018, the House Ways and Means Committee held a markup on eight bills related to opioid abuse, specifically among the Medicare population. Included in these bills are provisions from dozens of other opioid-related bills referred to the Committee. It is not clear at this point if and when these bills will be considered by the full House of Representatives. The House Energy and Commerce Committee reported 25 bills last week and an additional 32 bills on May 17. Chairman Greg Walden (R-Ore.) has stated his desire to move an opioid package out of the committee by Memorial Day, and House Majority Leader Kevin McCarthy (R-Calif.) additionally indicated his desire to have the full House consider opioid legislation in June. The final opioid legislation will likely include components of law enforcement, prevention, education, increasing access to treatment, and long-term recovery. ASHP continues to work with Congress to highlight the important ways that pharmacists can have a positive impact on addressing the opioid epidemic, and we will continue to engage with both the House and the Senate as they consider this important legislation.

Also on May 16, the House Appropriations Committee held a markup on a bill funding agriculture, rural development, Food and Drug Administration (FDA), and other programs for the fiscal year ending September 30, 2019. Importantly, the appropriations bill itself contains no mention of pharmacy compounding. However, the associated report language (which is not legislation and is not enforceable by law) discusses five specific areas of interest related to compounding:

  1. Drug Compounding Draft MOU — The Committee recommends that the FDA clarify the distinction between distribution and dispensing activities, and provide adequate time for public comment on a new draft MOU.
  2. Drug Compounding for Animals — The Committee agrees with the FDA’s decision to withdraw draft guidance that would have applied many of the standards applicable to outsourcing facilities regulated under Section 503B of the Food, Drug, and Cosmetic Act (FD&C Act) to veterinary compounding, without the clear statutory authority to do so.
  3. Drug Compounding Implementation Framework and Office Use Compounding — Of note, the Committee disagrees with the FDA’s guidance prohibiting office use compounding. The Committee urges the FDA to either prescribe a pathway for limited, safe, and controlled office use, or hold a public meeting so that FDA can clearly explain to respective stakeholders the legal rationale for disallowing office use.
  4. Drug Compounding Pharmacist on Pharmacy Compounding Advisory Committee — The Committee is concerned that current Committee members do not have sufficient expertise in compounding and urges FDA to include on the Advisory Committee pharmacists who have recent experience with compounding medications.
  5. Drug Compounding under State-Licensed Pharmacies — Finally, the Committee states that the FDA should continue to recognize that a pharmacy regulated under Section 503A of the FD&C Act is a state-licensed pharmacy subject to the standards of United States Pharmacopeia Convention (USP) for sterile and non-sterile pharmaceutical compounding or other applicable pharmacy inspection standards adopted by state law or regulation.

ASHP does not expect any compounding amendments to the bill and will continue to engage with both House and Senate Appropriations staff to ensure that any compounding proposals are in the best interest of patients. We believe that legislative changes are unwarranted at this time, as the FDA has not fully implemented the 2013 law. We will continue to work with the agency as they do so, including our forthcoming comments on recent guidance on compounding from bulk substances.