www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Drug Topics: Regulatory Framework for Human Drug Compounding
September 26, 2023
FDA

Activity Coordinators:
Thanh Tam Nguyen-Chu (thanh.nguyen-chu@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly DeFronzo (Kimberly.Defronzo@fda.hhs.gov)
Description

Compounded drugs serve an important medical need for certain populations who cannot be treated with FDA-approved medications, including pediatric patients or patients with allergies requiring drugs made without certain excipients. Although compounded drugs can serve an important medical need for certain patients, they also present a risk. FDA's compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to drugs compounded pursuant to provisions established in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning Human Drug Compounding. This presentation provides an overview of human drug compounding and its regulatory framework, differentiates drug compounding from the FDA new drug approval process, describes the bulk drug substance evaluation process, and provides examples.


References
  • Human Drug Compounding. U.S. Food and Drug Administration Web site. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding
  • Guidance for Industry Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance (March 2019) https://www.fda.gov/media/121315/download
  • Guidance for Industry Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (January 2017) https://www.fda.gov/media/94402/download
  • Guidance for Industry Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (January 2017) https://www.fda.gov/media/94398/download
  • Federal Food, Drug, and Cosmetic (FD&C) Act Sections 503A and 503B Section 503A: https://www.fda.gov/drugs/human-drug-compounding/section-503a-federal-food-drug-and-cosmetic-act Section 503B: https://www.fda.gov/drugs/human-drug-compounding/text-compounding-quality-act
  • Compounding Laws and Policies at https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
Learning Objectives
  • Discuss the basics of human drug compounding.
  • Describe the history and regulatory framework of human drug compounding and the differences between sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act.
  • Explain the evaluation process for bulk drug substances (BDS)1┬ánominated for use in compounding in accordance with section 503A of the FD&C Act (503A Bulks List) and bulk drug substances nominated for use in compounding in accordance with section 503B of the FD&C Act (503B Bulks List), and how the evaluation process differs from the new drug approval process

    1Sections 503A and 503B define a bulk drug substance as meaning "the same as active pharmaceutical ingredient as defined in 21 CFR 207.1 (b)" (see 21 CFR 207.3)
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Agenda
Day 1 September 26, 2023
Time Topic Speaker
1:00 - 2:00 PM EDT FDA Drug Topics: Regulatory Framework for Human Drug Compounding Mariestela Buhay, JD
Madeline Wolfert, MD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-070-L07-P, and ACPE Universal Activity Number JA0002895-0000-23-070-L07-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Buhay, Mariestela, JD, Regulatory Counsel, FDA/CDER/OCQC - nothing to disclose
  • Wolfert, Madeline, MD, Physician, FDA - nothing to disclose

Planning Committee
  • Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
  • DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
  • Nguyen-Chu, Thanh Tam, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team
  • Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary, therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.
ACCME Joint Accreditation
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