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FDA Issues Draft Guidance Addressing Prohibitions of Compounded Drug Wholesaling

On June 28, 2023, Food and Drug Administration (FDA) announced the availability of a draft guidance, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act, that describes how FDA intends to apply the wholesaling provisions of Section 503B of the Act to outsourcing facilities that compound drugs.
The document includes interpretation of the following “Key Terms:”

• “sold or transferred;”
• “entity other than the outsourcing facility that compounded such drug;” and
• “does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 503(b)(1).”

The document also provides examples of activities prohibited by the wholesaling provisions, as well as examples of activities not prohibited.

Comments to this draft guidance can be submitted anytime but are due to FDA by August 28, 2023, to be considered for the final guidance.

For further information from FDA, contact Dominic Markwordt, Center for Evaluation and Research, at 301-796-3100 or dominic.markwordt@fda.hhs.gov. Questions for NABP can be sent to NABP’s Professional Affairs Department at prof-affairs@nabp.pharmacy.

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FDA Announces New FAQs Addressing Compounding Inspections and Oversight; Two On-Demand Webinars Addressing FDA Compounding Inspections

Food and Drug Administration (FDA) has announced the availability of new frequently asked questions about compounding inspections and oversight.
In addition, the Agency has made available the following two on-demand webinars about FDA compounding inspections:

• FDA Inspections of Outsourcing Facilities: FDA provides an overview of the inspection process for compounding outsourcing facilities.
• What to Expect after an Inspection: 483s, Responses and Beyond. FDA provides an overview of what to expect after a compounding inspection.

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National Advisory Council for the Agency for Healthcare Research and Quality

Lemrey “Al” Carter, Executive Director/Secretary is pleased to announce that he will be representing NABP as a member of the National Advisory Council (NAC) for the Agency for Healthcare Research and Quality (AHRQ). The NAC provides advice and recommendations to AHRQ’s director and to the Secretary of the Department of Health and Human Services on priorities for a national health services research agenda.

The next meeting of the NAC will take place on Wednesday, July 12, 11:15 AM-3:30 PM ET. The meeting will be available through Zoom starting at 11:00 AM ET. If you are interested in accessing the meeting, instructions are provided on the AHRQ website.

For more information on the AHRQ NAC, its members, and the upcoming meeting agenda, please see the press release issued by AHRQ.

If you have any questions, please feel free to contact ExecOffice@nabp.pharmacy.

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Intravenous Hydration Clinics: Federal and State Regulatory Perspectives

As a reminder, the National Association of Boards of Pharmacy (NABP) invites you to register for a panel discussion titled, Intravenous Hydration Clinics: Federal and State Regulatory Perspectives, on Wednesday, July 26, 2023, from 3:00 to 4:30 PM ET.

The Food and Drug Administration (FDA), Federation of State Medical Boards (FSMB), NABP, and the National Council of State Boards of Nursing (NCSBN) will hold this virtual panel discussion with case study presentations for FSMB, NABP, and NCSBN members.

IV hydration clinics, which have grown in popularity in recent years, allow consumers to select an IV infusion from a menu of various vitamins and supplements advertised for various uses such as boosting immunity, promoting recovery, and remedying hangovers or fatigue.

The FDA has received reports of adverse events associated with drug products compounded at medical offices and clinics, such as IV hydration clinics, under insanitary conditions and issued a compounding risk alert in October 2021 to caution healthcare providers about the risks (FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions).

If you have not already done so, please register in advance for this meeting. Space is limited, so register soon. After registering, you will receive a confirmation email with information on how to join the meeting.

If you have any questions, please feel free to contact ExecOffice@nabp.pharmacy.

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Sterile Compounding Inspector Training Program Update

NABP understands the level of importance our member boards place on the training of their inspectors to the current sterile compounding practice standards. Our continued support of this training led to the recent development of standards by which sterile compounding inspector training programs could be evaluated by NABP staff and subsequently approve those programs that meet the standards. NABP will provide financial assistance to one inspector, per state each year, who attends an NABP approved sterile compounding inspector training program.

NABP is pleased to announce the approval of the sterile compounding inspector training program developed by the University of South Carolina College of Pharmacy, Kennedy Pharmacy Innovation Center (KPIC). Below are the details of this program:

• The initial training will be completed at their compounding facility in Columbia, South Carolina
• The program will combine two days of practical compliance training related to USP Chapters <797> and <800>, along with a half-day session of state inspector training.
• The inspector training portion of the program will be conducted by a qualified state pharmacy inspector.
• The training will provide the attendees with 20 hours of live ACPE approved Continuing Pharmacy Education.
• Attendees that successfully complete the training will receive a certificate of completion that will require an online refresher course every three years to stay current on any new developments in the applicable USP standards and/or compounding practices.
• The cost for this onsite training will be $1300 which includes breakfast, lunch, training materials, and parking.
• NABP will continue to provide financial support for one inspector per state each year in the amount of $1995. The remaining $695 can be applied to travel expenses incurred to attend this training program. Once KPIC has notified NABP that an inspector has attended and completed the program, NABP will send the attendee a travel reimbursement form along with instructions on how to submit for payment.
• To register an inspector for this program that will be accepting the annual grant for your state, please contact governmentaffairs@nabp.pharmacy and indicate the name and contact information for the attendee approved by your board to complete this training. Details will be sent directly to your inspector on how to register.
• Additional inspectors that will be attending a training session, that are not receiving grant funding from NABP, can register by going to: SCCOP KCIP Sterile Compounding Training

Please note that KCIP will not be providing an update program for recertification of the CISCI certificate issued by CriticalPoint. Inspectors that hold a CriticalPoint CISCI certificate have the following options:

• Attend the renewal program offered by CriticalPoint and incur the full costs for this online training program.
• Attend the full onsite training offered by KCIP and receive NABP financial support according to the terms noted previously.

** Inspectors that hold either a current KCIP Certificate of Completion or CriticalPoint CISCI certification are deemed to meet the criteria defined in the NABP Multistate Pharmacy Inspection Blueprint Program MOU.

If you have any questions, please email governmentaffairs@nabp.pharmacy.

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DEA Publishes Final Rule to Allow Transfer of Electronic Prescriptions for Controlled Substances Between Pharmacies for Initial Filling

Drug Enforcement Administration (DEA) has published the final rule, Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling, which will be effective August 28, 2023.

The final rule provides clarity on existing federal regulatory requirements, as well as to facilitate the proper dispensing of electronic prescriptions for controlled substances (EPCS) by amending DEA regulations to allow the transfer of electronic prescriptions for Schedule II-V controlled substances between registered retail pharmacies for initial filling, upon request from the patient, on a one-time basis, and if allowable under existing state or other applicable law.

Additionally, the final rule requires the transfer to be communicated directly between two licensed pharmacists, the prescription must remain in its electronic form, and the required prescription information must not be altered during the transmission. Record-keeping requirements for EPCS are also included for the transferring and receiving pharmacies for the initial fill only, as DEA notes that the transfer of EPCS for refill dispensing is addressed by 21 CFR 1306.25.

Any questions pertaining to the final rule should be addressed to Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration by telephone at (571) 776-3882 or via email at dpw@dea.gov.

The National Association of Boards of Pharmacy (NABP) encourages you to share this information with licensees within your state.

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