§ 211.167 Special testing requirements

(a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine conformance to such requirements. The test procedures shall be in writing and shall be followed.

(b) For each batch of ophthalmic ointment, there shall be appropriate testing to determine conformance to specifications regarding the presence of foreign particles and harsh or abrasive substances. The test procedures shall be in writing and shall be followed.

(c) For each batch of controlled-release dosage form, there shall be appropriate laboratory testing to determine conformance to the specifications for the rate of release of each active ingredient. The test procedures shall be in writing and shall be followed.

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What FDA inspectors cite under § 211.167

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Sterility/pyrogen-free testing 124
• Sterility/pyrogens - test methods written, followed 37
• Controlled release dosage form testing 4
• Controlled release test methods written, followed 3

Warning letters citing § 211.167

34 FDA warning letters since 2017 cite this section ; the most recent:

• New Life Pharma LLC 14 Apr 2026
• Bio-Medical Pharmaceutical Manufacturing Corporation 5 Feb 2026
• Acme United Corporation 10 Oct 2025
• Exela Pharma Sciences, LLC 2 Jul 2025
• Wuxi Medical Instrument Factory Co., Ltd. 4 Apr 2025
• Advanced Pharmaceutical Technology 14 Mar 2025
• Global Pharma Healthcare Private Limited 20 Oct 2023
• Signature Biologics, LLC 18 Sept 2023
• Kimera Labs, Inc. 1 Sept 2023
• US Specialty Formulations, LLC 26 Jul 2023
• Maitland Labs of Central Florida 6 Aug 2021
• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 8 Sept 2020

FDA guidance that cites § 211.167

• Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates: Guidance for Industry 8 Sept 2026
• Container Closure Systems for Human Drugs and Biological Products draft 13 Aug 2026
• Temporary Policies for Compounding Certain Parenteral Drug Products: Guidance for Industry 11 Oct 2024
• Quality Considerations for Topical Ophthalmic Drug Products draft 27 Dec 2023
• Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act 9 Feb 2023
• Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Guidance for Industry: Draft Guidance for Industry draft 28 Jul 2020
• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry draft 22 Jan 2020
• Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for Industry 18 Jan 2018
• Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff 11 Jan 2017
• CPG Sec. 490.200 Parametric Release of Parenteral Drug Products Terminally Sterilized by Moist Heat 1 Jul 2012
• Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes: Guidance for Industry 26 Feb 2010
• Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry 25 Feb 2008
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry 4 Oct 2004

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978