Follow-Up To Long-Term Care Pharmacy Listening Session

DATE: December 22, 2015

Jane A. Axelrad
Associate Director for Policy (HFD-005)
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

Re: Follow-Up To Long-Term Care Pharmacy Listening Session

Dear Ms. Axelrad:

The Senior Care Pharmacy Coalition (SCPC), one of the organizations that participated in the Food and Drug Administration’s (FDA) August 26, 2015 “listening session” on long-term care (LTC) pharmacy (the Listening Session), submits the following supplemental information that FDA requested to further
elucidate LTC pharmacy issues and the potential impacts of FDA’s Draft Repackaging Guidance on LTC patient care.

At the meeting, FDA requested additional information from the industry, including written copies of opening statements; representative text of state “emergency kit” (or e-kit) laws; certain perspectives on product expiration dating; and definitional characteristics that FDA could use to identify LTC pharmacies. We are pleased to respond to that request, and have appended to this letter: (1) the written version of the statement that Robert Warnock made on behalf of the SCPC during the Listening Session (Attachment 1); (2) a summary and certain excerpts of state e-kit laws (Attachment 2); and (3) copies of federal definitions and policies appropriate to define LTC pharmacies (Attachment 3).

In addition to information addressing FDA’s requests for data that were raised at the Listening Session (summarized in Section I below and included as attachments), we also provide specific policy recommendations for ways in which the Draft Guidance could be amended that we believe both meets the
agency’s policy goals and addresses the operational challenges faced by the regulated LTC pharmacy community. Thus, in Section II below, we provide three specific proposed changes to the Draft Guidance, addressing prepackaging generally, automated dispensing, and emergency kits.

Click here to see the full letter.

Click here to see SCPC’s attachments to the full letter.