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.

• 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

• 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 nominated 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)

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.

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

• 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

• 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