Home > Regulatory Considerations of Nitrous...

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.

Likis FE, Andrews JC, Collins MR, et al. Nitrous Oxide for the Management of Labor Pain [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Aug. (Comparative Effectiveness Reviews, No. 67.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Appendix FRegulatory Considerations of Nitrous Oxide

Nitrous oxide is used in the U.S. for both medical and nonmedical purposes. The following section will focus on the regulation of nitrous oxide used as analgesia for labor pain. Nitrous oxide as a labor analgesia is governed by a limited patchwork of laws, regulations, and standards.

Regulation by federal entities

Like all medical gases, nitrous oxide is regulated by the U.S. Food and Drug Administration (FDA) as a prescription drug.1 Title 21 of the Code of Federal Regulations describes the required manufacturing (Good Manufacturing Practices) and distribution practices for prescription drugs, performance standards for medical gas delivery devices, and safety requirements for medical gas containers. There are only a few FDA regulations that specifically or solely apply to nitrous oxide. These regulations describe labeling requirments, manufacturing requirements, and performance standards for delivery systems.2

Nitrous oxide also falls under the purview of the United States Pharmacopeia (USP). The USP is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines and food ingredients distributed and consumed worldwide. USP standards are enforced by the FDA.

Two federal agencies have weighed in on the use of nitrous oxide in the workplace. The National Institute for Occupational Health and Safety (NIOSH), the federal agency responsible for conducting research and making recommendations to prevent injury and illness in the workplace, has established a recommended exposure limit (REL) for nitrous oxide of 25 parts per million as a eight hour time weighted average. In 1994, NIOSH published an alert (DHHS (NIOSH) Publication No. 94-100) that provided guidance on how to control workplace exposures to nitrous oxide during anesthetic administration.3

The Occupational Safety and Health Administration (OSHA) is the federal agency that sets and enforces workplace health and safety standards. OSHA has not set a threshold standard for nitrous oxide exposures in the workplace,3 but is developing requirements for monitoring workplace exposures to nitrous oxide.4 OSHA has addressed public safety by requiring all piped systems that transfer and distribute nitrous oxide to comply with safety standards set by the Compressed Gas Association.5

Companies that sell nitrous oxide and facilities that store nitrous oxide are subject to certain environmental regulations. The U.S. Environmental Protection Agency (EPA) maintains and publishes every two years a list of chemicals sold in the U.S. This list, the Toxic Substances Control Act (TSCA) inventory, includes nitrous oxide. Facilities that use and store nitrous oxide must submit material safety data sheets and report nitrous oxide inventories to the local emergency planning commission, the organization responsible for local emergency preparedness and response.

Regulation by state legislatures and agencies

In addition to the federal regulations that govern the manufacture, distribution, and storage of nitrous oxide, there are state laws that are meant to promote the safe use, storage, and delivery of nitrous oxide. An increasing number of states have enacted legislation that attempt to limit youth access to nitrous oxide in order to reduce the prevalence of nitrous oxide abuse by young people. Some state legislatures and licensing boards have enacted legislation or rules that define who may administer or assist in administering nitrous oxide in a medical setting. Some states have enacted community and worker right to know laws. These laws mandate reporting of environmental exposures (accidental releases and on-site storage exposures) to a local agency and mandate notice of exposures to employees and community residents. Finally, it is not uncommon for state and local governments to regulate and enforce building codes that address the installation, testing, and maintenance of pipelines used to deliver nitrous oxide to medical facilities.

Regulation by national organizations

Professional organizations are an integral part of the regulator environment for nitrous oxide. The American Conference of Governmental Industrial Hygienists (ACGIH) is a professional association of industrial hygiene personnel within government agencies. ACGIH establishes the Threshold Limit Values (TLVs) for chemical substances and physical agents and Biological Exposure Indices (BEIs) as guidelines for use in the industrial hygiene field. This group has set a threshold limit value (TLV) for nitrous oxide of 50 ppm of air as an eight hour time weighted average.6

The Compressed Gas Association (CGA) writes regulations and standards for compressed gases. Title 41 of the Code of Federal Regulations applies to federal contracts and requires that “the pipe systems for the in-plant transfer and distribution of nitrous oxide shall be designed, installed, maintained and operated in accordance with Compressed Gas Association Pamphlet G8.11964.”7 OSHA has also adopted the CGA code for piped systems that deliver and transfer nitrous oxide.5

The National Fire Protection Association (NFPA) develops and writes consensus standards for medical gas delivery systems (pipelines) in healthcare facilities. NFPA 99 sets standards for monitoring and testing of nitrous oxide delivery systems. The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) requires healthcare facilities to comply with NFPA 99 (Annex C). The American Welding Society, the Manufacturers' Standardization Society of the Valve and Fittings Industry, the American Society of Mechanical Engineers, and the American National Standard Institute (ANSI) all have set standards for the installation, design and testing of medical gas pipelines.

1.
Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for hospitals, nursing homes and other health care facilities. Mar, 2001.
2.
Code of Federal Regulations Title 21: Food and Drugs. Department of Health and Human Services, Food and Drug Administration; 2011.
3.
NIOSH alert: request for assistance in controlling exposures to nitrous oxide during anesthetic administration. MMWR Morb Mortal Wkly Rep. 1994 Jul 22;43(28):522. [PubMed: 8022400]
4.
Occupational Safety and Health Guideline for Nitrous Oxide. Occupational Safety and Health Administration, Department of Labor; 2011.
5.
Code of Federal Regulations Title 29: Labor. Department of Labor, Occupational Safety and Health Administration; 2010.
6.
Conference of Governmental Industrial Hygienests. Available at: [cited August 30, 2011]; www​.acgih.org/About/American.
7.
Code of Federal Regulations Title 41: Public Contracts and Property Management. Department of Labor, Public Contracts; 2005.
Cover of Nitrous Oxide for the Management of Labor Pain
Nitrous Oxide for the Management of Labor Pain [Internet].
Comparative Effectiveness Reviews, No. 67.
Likis FE, Andrews JC, Collins MR, et al.

Download

AHRQ (US Agency for Healthcare Research and Quality)

PubMed Health Blog...

read all...

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...