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Nuclear Medicine: Introduction to U.S. & International Regulations and Clinical Practice Resources: U.S. Regulations

U.S. Regulations Overview

To practice most medical specialties, a physician needs only the proper training and a state medical license.  Nuclear medicine requires more.  Besides the proper training and medical license, a nuclear medicine physician must also have the government's permission to possess radioactive materials and to administer radiopharmaceuticals to patients.  This is accomplished by obtaining a radioactive materials license for the facility where the materials are used.  The physician who prescribes the radiopharmaceutical for the patient must be an authorized user for that radioactive material under the facility's radioactive materials license.  One who administers the radiopharmaceutical to the patient must be an authorized user or must work under the supervision of an authorized user.

The nuclear medicine practice must have a radioactive materials license: a special license that permits the possession and medical use of the specific radioactive materials the facility will be using.  This license must cover the radioactive materials in the radiopharmaceuticals for the patients as well as other radioactive materials, such as those used to test the radiation detection equipment. The license must also specify the precise locations (by room) in which radioactive materials will be stored or used. In most states, the state government has the authority to grant this license. These states are known as "Agreement States" because they are operating their programs under an agreement with the U.S. Nuclear Regulatory Commission (NRC).  The NRC allows the state to administer the program as long as the NRC is assured that the state is maintaining standards at least as strong as those of the NRC.  Federal facilities, such as Department of Veterans Affairs hospitals and Department of Defense hospitals, are regulated by the NRC rather than by the state in which the facility is located.

Every site with a radioactive materials license will have someone designated on the license as the Radiation Safety Officer (RSO). The RSO is responsible for assuring the proper security and handling of the radioactive materials in the possession of the facility and for assuring the safety of the workers and general public. 

Sites of use or storage of radioactive materials will always have signs warning the public that there are such materials in the area, such as those shown at the top of this box.

Similarly, those who transport radioactive materials must have authority to do so and have signage.  You may have noticed a delivery truck with the symbol for radiation on the side. 

When radioactive materials are transported, stored, or used, they are kept inside of special containers that protect those who are near the radioactivity.  This protection, known as "shielding", uses special materials that help stop the radiation from escaping and affecting those nearby.

U.S. Code of Federal Regulation

Title 10 of the U.S. Code of Federal Regulations (C.F.R.) deals with Energy.  Chapter I, parts 1–199 are devoted to the Nuclear Regulatory Commission.

While several sections are applicable to those practicing nuclear medicine, parts 20 and 35 are the most often referenced:

10 C.F.R. §§ 20.1001–20.2402 (at NRC site), Standard for Protection against Radiation.

10 C.F.R. §§ 35.1–35.4002Medical Uses of Byproduct Material.

Additionally, the U.S. Department of Transportation regulates the transportation of radioactive materials.  These regulations may be found in:

49 C.F.R. §§ 100–185, Hazardous Materials and Oil Transportation.

The U.S. Nuclear Regulatory Commission maintains a site with all parts of Title 10, Code of Federal Regulations, as well as other helpful regulations and statutes.

For the most up-to-date changes, be sure to consult the Federal Register.

Dept. of Transportation

Whenever radioactive materials are transported in vehicles on public roads, on trains, or on airplanes, the U.S. Department of Transportation, the DOT, regulates these as special hazardous materials (hazmat).

The DOT's Hazmat Safety Community has a wide range of resources. Hazmat Legal References include:

49 U.S.C. §§ 5101–7133, Federal Hazardous Materials Transportation law (Aug. 10, 2005) 

49 C.F.R. §§ 100–185, Hazardous Materials and Oil Transportation 

The DOT also has several user-friendly references available on their Hazmat Regulations Site.  The DOT has even developed a very basic brochure for cargo handlers about How to Handle Radioactive Material Packages.

Links to several resources with International Transport Standards are also available via the DOT website.  Look to the right for the "International Menu." 

Food and Drug Administration

All radiopharmaceuticals administered to patients must be approved for use by the U.S. Food and Drug Administration (FDA).

The FDA, part of the Department of Health and Human Services, regulates diagnostic radiopharmaceuticals based on 21 C.F.R. §§ 315.1–315.6 and 601.30–601.35 Therapeutic radiopharmaceuticals are regulated under several sections of title 21, just as are non-radioactive pharmaceuticals that are used for therapy.

The FDA also regulates medical devices including the imaging cameras used in nuclear medicine.

Because some areas of regulatory responsibility fall under both the FDA and NRC, the agencies have a memorandum of understanding to clarify each agency's responsibilities. 

Oklahoma Radioactive Materials Regulations

As an "Agreement State," Oklahoma has Environmental Quality regulations which the U.S. Nuclear Regulatory Commission has determined are consistent with the NRC's recommendations. The Oklahoma regulations are codified in the Oklahoma Administrative Code:

Okla. Admin. Code §§ 252:410-1-1 through 410-23-1 (Radiation Management)

For the most up-to-date Oklahoma Code actions, consult the latest Registers.

The Radiation Management Section of the Department of Environmental Quality does not have a Web presence.  The Section may be contacted by mail:

Radiation Management Section
OK Dept. of Environmental Quality
P.O. Box 1677
Oklahoma City, OK  73101-1677

By phone:  (404) 702-5155

Information concerning Oklahoma's Radiation Management Advisory Council is available on the Internet and includes the Council members, scheduled meetings, and previous council minutes.

Nuclear Regulatory Commission

The Nuclear Regulatory Commission (NRC) is an independent U.S. government agency that is charged with enabling the safe use of radioactive materials for beneficial civilian purposes while protecting radiation workers, the public, and the environment.  The NRC regulates nuclear power plants, medical uses of radioactive materials, and industrial uses of radioactive materials.  The NRC does not regulate devices that emit radiation unless the device contains radioactive materials.  Therefore, the NRC does not regulate routine x-ray equipment or CT scanners, for example.   The NRC coordinates with the U.S. Food and Drug Administration regarding devices that involve radioactive materials and drugs that are radioactive, radiopharmaceuticals.

The NRC regulates the medical use of radioactive materials including regulations concerning radiation exposure. These regulations are promulgated via the Code of Federal Regulations, as described in the box above.   To assist the agency with being responsive to the needs of the medical community, the NRC has established an Advisory Committee on the Medical Uses of Isotopes (ACMUI).  The committee's reports are available on the committee's Web site. 

The NRC directly oversees the medical use of radioactive materials in all Federal facilities and in those states that have chosen not to have their own program for regulation of radioactive materials.  To assist those with a radioactive materials license to maintain compliance, the NRC has developed a Medical Uses Licensee Toolkit that has a very extensive collection of helpful information.

The thirteen states in which radioactive materials are regulated by the NRC are shown in yellow. The "Agreement States" are shown in orange. Michigan has given the NRC its letter of intent to become an agreement state.

"Agreement States," those states that have entered into agreements with the NRC that allow the state to administer the radioactive materials licensing, will have regulations at least as stringent as the NRC. Because state regulations tend to be similar to those of the NRC, the Licensee Toolkit may be a helpful reference for them as well.  Detailed information about the Agreement State Program is available on the NRC Web site.

Note that the NRC's predecessors were the Atomic Energy Commission (AEC) and the Energy Research and Development Administration (ERDA).  You may see these mentioned in older publications.

Understanding NRC Regulations

For those practicing clinical nuclear medicine, dealing with these regulations can be a challenge.  A common challenge is to comply with the regulation while not having the regulations take over the clinical practice. For a very practical approach to regulation compliance,  Jeffry A. Siegel's book, Guide for Diagnostic Nuclear Medicine and Radiopharmaceutical Therapy, is excellent (ISBN: 0972647821).  Siegel's very practical approach to quality clinical practice provides step-by-step guidance for establishing procedures that comply with NRC regulations.

Guide for Diagnostic Nuclear Medicine and Radiopharmaceutical Therapy

The Nuclear Regulatory Commission also provides guides to assist with implementing programs that will comply with NRC regulations.  The online "Reg Guides" most often used by clinical nuclear medicine facilities fall under Division 8, Occupational Health, however other areas may be of interest.  Every Radiation Safety Officer should know that these guides are available.

800 N. Harvey Oklahoma City, OK 73102 405.208.5271