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FDA Webinar on Cannabis Products – October 29, 2024

The Food and Drug Administration (FDA) Division of Drug Information will be hosting a webinar on October 29, 2024, 1 – 2:00 PM (ET), titled FDA Drug Topics: Cannabis Products and the Potential Impact on Patients. Attendees will be provided with insights into the landscape of the cannabis marketplace and general information on how products are manufactured and regulated. The presentation will also discuss clinical and pharmacological considerations and known drug-drug interactions, identify common misconceptions on the use and safety of cannabis products, and provide ways to identify and report adverse events.

More information, including the registration link, is attached.

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FDA Grants DSCSA Exemption to Connected Trading Partners

On October 9, 2024, FDA announced that they have granted an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners. The agency informed NABP of the exemption in the attached email. While NABP is still evaluating the exemption, the following highlights the critical components:

• Who is affected: Trading partners who have initiated their systems and electronic data connections, but who still face challenges with missing, incomplete, or inaccurate data.
• What is exempted: Key interoperable DSCSA requirements that were part of the previous stabilization period like exchanging transaction information and transaction statements electronically, including product identifiers at the package level, and certain verification request requirements.
• Timeline:
  • For manufacturers and repackagers, exemptions last from November 27, 2024, until May 27, 2025.
  • For wholesalers, exemptions are granted until August 27, 2025.
  • For dispensers with 26 or more full-time employees, the exemption period extends until November 27, 2025.
• Scope: These exemptions apply to specific requirements under Section 582(g)(1) of the FD&C Act. Other existing DSCSA obligations remain in effect. Notably, trading partners who have not yet initiated the required systems are not covered by these exemptions. 

Moreover, the 4 operational imperatives that NABP has been emphasizing are still required and in effect:

1. Know your prescription drug suppliers (sources).
2. Know where your product tracing, also known as transaction information (data), is being stored and how to access it.
3. Know what suspect product is, how to identify it, how to investigate it, and what to do if it is deemed illegitimate.
4. Develop, update, and adhere to robust prescription drug purchasing policies and procedures (P&Ps) that accurately reflect your internal processes.

If your board has any questions, please contact Josh Bolin at jbolin@nabp.pharmacy.

See attachment.

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FDA Issues Temporary Policies for Compounding Certain Parenteral Drug Products

In response to the public health emergencies issued as a result of Hurricanes Helene and Milton, on October 11, 2024, Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research Office of Compliance announced the availability of an immediately-in-effect guidance titled Temporary Policies for Compounding Certain Parenteral Drug Products. 

This guidance states that FDA does not intend to take action against a pharmacy that is not registered as an outsourcing facility, including a hospital or health-system pharmacy, for providing certain compounded parenteral drugs to a hospital without first obtaining a patient-specific prescription, or for compounding a drug that is essentially a copy of a commercially available drug, provided certain conditions are met.

Additionally, it says that FDA does not intend to take action against an outsourcing facility for compounding a drug product that is essentially a copy of an approved drug, for using a bulk drug substance that is not on FDA’s 503B Bulks List, or for not meeting current Good Manufacturing Practice requirements pertaining to product stability testing and the establishment of an expiration date, provided certain conditions are met.

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Save the Date for the NABP Forums in October 2025!

The National Association of Boards of Pharmacy (NABP) is pleased to announce its new NABP Forum schedule in which forums for all groups will be held October 27-30, 2025, in Rosemont, IL.

NABP held its first forum in fall 2010 to increase engagement among board of pharmacy members. Based on input over the years, the Association has expanded the forum series to hold an annual forum for both the executive officers and board members and a biennial forum for the compliance officers in conjunction with legal counsel. Due to the success of last year’s combined executive officer, compliance officer, and legal counsel forum, in 2025, NABP is holding programming for all groups, including members, over the course of one week. As in the past, there will be a day and a half of programming for each group. The schedule change is intended to provide joint sessions among the groups and make it easier for board of pharmacy staff and members to plan for attendance.

We hope you find the advance notice of the new schedule helpful when planning your 2025 board meetings. Additional information about the meeting will be provided in future correspondence.

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USP Provides Free Resources to Address IV Fluid Shortages

United States Pharmacopeia (USP) is providing the following two resources, at no charge, to support healthcare professionals in addressing shortages of manufactured intravenous (IV) fluids resulting from the damage caused by Hurricane Helene:

1. Operational considerations for sterile compounding by pharmacy compounders not registered as outsourcing facilities during public health emergencies and natural disasters; and
2. Complimentary USP monographs for use during public health emergency.

Click here to request access to this information.

Contact USP Healthcare Quality and Safety staff at CompoundingSL@usp.org with any additional questions.

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NABP Shares DSCSA Dispenser Guide

The National Association of Boards of Pharmacy (NABP) is pleased to share it has created a Drug Supply Chain Security Act (DSCSA) Dispenser Guide. The guide aims to help dispensers with DSCSA compliance. It is modeled after FDA’s DSCSA guidance document.

To access the Dispenser Guide for download, sign up for our Pulse updates.

If your board has any questions, please contact Josh Bolin at jbolin@nabp.pharmacy.

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