U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Drug Compliance Programs
  1. Guidance, Compliance, & Regulatory Information

Drug Compliance Programs

FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available.

The FDA Compliance Program Manual listing is available at Compliance Program Manual

Program No.Compliance Program Title
7348.001In Vivo Bioequivalence (PDF - 77KB)
[HTML version]
7348.809ARadioactive Drug Research Committee (PDF - 142KB)
7346.832Preapproval Inspections (PDF - 700KB)
7352.002Unapproved New Drugs (Marketed, Human, Prescription Drugs only) (PDF - 52KB)
[HTML version]
7352.004In Vitro Methods Development and Validation for Generic Drugs
(Not available online)
7353.001Postmarketing Adverse Drug Experience (PADE) Reporting Inspections
7356.000Inspections of CDER-led or CDRH-led Combination Products (PDF - 811 KB)
7356.002Drug Manufacturing Inspections (PDF - 524 KB) 
7356.002ASterile Drug Process Inspections (PDF - 292KB)
7356.002BDrug Repackers and Relabelers (PDF - 182KB)
7356.002CRadioactive Drugs (PDF - 180KB)
7356.002ECompressed Medical Gases (PDF - 239KB)
7356.002FActive Pharmaceutical Ingredients (PDF - 150 KB)
7356.002MSurveillance Inspections of Protein Drug Substance Manufacturers (PDF - 940KB)
7356.002PPositron Emission Tomography (PDF - 183KB)
7356.008Drug Quality Sampling and Testing - Human Drugs
7356.013Import Human Drug Operations
(Not available online)
7356.014Drug Listing
(Not available online)
7356.014ADrug Listing - Labeling Review
(Not available online)
7356.020Compendial Monographs Evaluation and Development (CMED)
(Not available online)
7356.020ACompendial Methods Assessment
(Not available online)
7356.021Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
7356.022Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug Marketing Act (PDMA)
7356.040Outsourcing Facility Inspections
7356.843Postapproval Inspections (PDF - 592KB)
7361.003OTC Drug Monograph Implementation (PDF - 51KB)
7363.001Fraudulent Drugs (PDF - 68KB)

Resources For You

Back to Top