August 2023 Electronic Mailbags
August 10, 2023
August 17, 2023
August 29, 2023
August 31, 2023
FDA Compounding Quality Center of Excellence Annual Conference – Ten Years as a Regulated Outsourcing Facility Industry: Addressing Challenges to Improve Patient Care
The National Association of Boards of Pharmacy (NABP) is pleased to announce that the Food and Drug Administration (FDA) Compounding Quality Center of Excellence is holding its annual conference titled, “Ten Years as a Regulated Outsourcing Facility Industry: Addressing Challenges to Improve Patient Care,” virtually on September 11-13, 2023.
The conference will convene stakeholders from across the compounding industry to discuss emerging trends and best practices through presentations, panels, and interactive sessions. Registration is free.
NABP encourages you to forward this information to your staff and to health care professionals in your state. For more information, please visit https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-annual-conference-09112023#event-information.
FDA Announces Availability of Free “Home Study” CE Webinars
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research Division of Drug Information announces the availability of on-demand home study webinars for pharmacists and pharmacy technicians as well as for physicians, physician assistants, nurse practitioners, nurses, and certified public health professionals. Each webinar offers one hour of continuing education credit.
Revised NABP Universal Inspection Form
NABP is pleased to inform you that the revisions to the NABP Universal Inspection Form have been completed and the finalized form, separated into three chapters, is accompanied by this memo.
The updated form incorporates all of the revisions to The United States Pharmacopeia (USP) Chapters 795 and 797, which were published in November of 2022, as well as USP Chapter 800. In the development of this revised form, NABP completed the following steps:
- Multiple NABP staff and inspectors reviewed the form and provided feedback;
- NABP reached out to a number of stakeholders, including state inspectors;
- NABP utilized subject matter expert, Abby Roth of Pure Microbiology for USP 797 revisions; and
- The USP Expert Compounding Committee Leadership group provided guidance.
An important addition, outside of the 2022 chapter revisions, is the incorporation of a USP chapter reference to each of the principal questions in the form. The form, within the Excel file format version, also has conditional formatting where the answer to the principal question will determine if follow up details are asked of the facility being inspected. The attached forms, divided into the three USP Chapters, have been provided in a columnar Microsoft Word document format for your review purposes and include all potential questions that may be posed during an inspection.
The NABP Member Relations and Government Affairs team will be working with the states currently participating in the NABP Multistate Pharmacy Inspection Blueprint Program (Blueprint Program) on either adoption of the revised Universal Inspection Form or a crosswalk of the revised form to the current State inspection form or process.
If you would like to receive the form in the Excel file format to utilize the conditional formatting or have any questions or feedback on the inspection form or content, please email Inspections@nabp.pharmacy.
USP Virtual Inspector Training Program
NABP understands the level of importance our member boards place on the training of their inspectors to the current compounding practice standards. Our continued support of the critical public health and safety role state inspectors play has led to the recent development of a virtual inspector training program with The United States Pharmacopeia (USP).
This program includes three, self-paced e-learning modules related to USP Chapters 795, 797 and 800, a recorded on-demand webinar on compounded preparation monographs, as well as a live stream Q&A session with USP staff and USP compounding expert committee members.
USP has worked collaboratively with NABP to provide this training at a reduced cost of $148 per participant for state inspectors and NABP staff only. NABP will incur the cost of this training for one inspector per state for those states that are currently participating in the NABP Multistate Pharmacy Inspection Blueprint Program (Blueprint Program).
All inspectors will need to indicate their interest in participating in the training program by sending an email to governmentaffairs@nabp.pharmacy. If you are a participating state in the Blueprint Program, please indicate in the email which inspector is eligible for the NABP funding grant.
Once you have provided this information to NABP, your inspector(s) will receive an email directly from USP that will provide a non-public link to complete the training program registration. All participants are highly encouraged to complete the e-learning modules prior to the live Q&A session with the USP team. The live Q&A session with the USP team will be held on October 23, 2023, from 10-12 noon EST. More information will come with your completed registration.
This training program is not intended to be an alternative to the Sterile Compounding Inspector Training program that is currently provided by the University of South Carolina College of Pharmacy for initial training of inspectors on USP Chapter 797 compliance or the renewal of SCIT certification.
If you have any questions on this USP training or want to request more information on how your state can participate in the Blueprint Program, please email governmentaffairs@nabp.pharmacy.
1-Year FDA Enforcement Discretion regarding 2023 requirements under DSCSA
On August 25, the Food and Drug Administration (FDA) finalized its guidance on the compliance policies for the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA’s guidance document details that the FDA does NOT intend to take action to enforce requirements under Section 582(g)(1) until after November 27, 2024. These requirements, originally slated to go into effect on November 27, 2023, will help to improve the security of the drug supply chain by requiring trading partners to share electronic product tracing data.
- By exercising enforcement discretion, the FDA has effectively provided a blanket enforcement delay for one year for all the approaching 2023 requirements, including product tracing requirements and further extending product verification requirements enforcement.
- FDA also notes that additional time is necessary for trading partners to move forward with capturing and sharing data in an electronic and interoperable manner.
- The guidance also grants enforcement discretion for product identifier transactional data for any product that is introduced into commerce by manufacturers or repackagers, prior to November 27, 2024. This is intended to allow any existing inventory in the supply chain to be exhausted after this date.\
The agency is referring to this delay as a “stabilization period” to ensure that trading partners continue to work toward compliance. NABP will continue to evaluate the guidance and will provide insights on how enforcement discretion may impact your state’s respective regulated populations. NABP is also exploring creating a model policy/guidance document to assist states in evaluating your plans regarding DSCSA implementation.
On August 30, the FDA also released the guidance for Enhanced Drug Distribution Security at the Package Level. NABP is evaluating this guidance and will provide more information to states in the coming weeks.
Finally, FDA’s guidance on delayed enforcement will NOT impact NABP’s plans to move forward with our educational plans for regulators and trading partners, or the full launch of Pulse by NABP later this year.
If you have any questions, please feel free to contact me via email at jbolin@nabp.pharmacy.
Register for USP Virtual Meeting – Mitigating Cancer Drug Shortages
On Tuesday, September 26, 2023, 9:00 – 11:00 ET, the American Cancer Society (ACS), American Cancer Society Cancer Action Network (ACS CAN) and the USP Convention will hold a virtual meeting with key thought leaders and pharmaceutical supply chain experts to identify interventions to address cancer drug shortages.
The event will feature experts who will help attendees better understand current shortages, obtain insights that could prevent future shortages, and improve access to lifesaving cancer treatments. In addition, recommendations for actions needed to prevent and mitigate shortages will be discussed.
Additional information, including speakers and a formal agenda, will be made available soon. Click on this link to register.
If you have questions, contact Amy Sonderman at amy@usp.org, or Diana Newhart at diana.newhart@usp.org.