Scope & Applicability
Product Classes
2New certification process for approval of designated medical gases
Includes oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air.; stability testing and expiration dating are not required for DMGs; Referred to as DMGs in distribution records; A drug manufactured or stored in a liquefied, nonliquefied, or cryogenic state
Stakeholders
3Entity responsible for submitting applications under section 524B
Any person or group of persons marketing, manufacturing, processing, or developing a drug; Entity maintaining information for demonstrations of safety and effectiveness
Source of the initial COA for DMGs; The person that initially produces a DMG by chemical reaction or physical separation
Regulatory Context
Attributes
4Key tests for vaccine purity should be validated
Quality attribute of the gas to be preserved
requirement for sameness between generic and RLD
Quality attribute of the gas to be preserved
Related CFR Sections (3)
- 21CFR201.161§ 201.161 Medical gases.
(a) The requirements of sections 503(b)(4) and 502(f) of the Federal Food, Drug, and Cosmetic Act are deemed to have been met for a designated medical gas or a medically appropriate combination of designated medical gases if the labeling on its final use container bears the following:Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
See Also (8)
- 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry: Guidance for Industry (Status: Final)
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs (Status: Final)
- CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (Status: Final)
- CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations* (Status: Final)
- CPG Sec. 480.100 Requirements for Expiration Dating and Stability Testing (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)