ML19247A439
| ML19247A439 | |
| Person / Time | |
|---|---|
| Issue date: | 06/06/1979 |
| From: | Hendrie J NRC COMMISSION (OCM) |
| To: | Bellmon H SENATE |
| Shared Package | |
| ML19247A440 | List: |
| References | |
| NUDOCS 7907310541 | |
| Download: ML19247A439 (2) | |
Text
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.k UNITED STATES "2 gI]'Z i j NUCLEAR REGULATORY COMMISSION e c /2 (
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V/ ASH IN GTO N, D.C. 20555 3
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June 6, 1979 OFFICE OF THE CHAIRMAN The Honorable Henry Bellmon United States Senate Washington, D.C.
20510
Dear Senator Bellmon:
This letter responds to your April 12, 1979 inquiry, which included a letter from your constituent, Rodney D. Ice, Ph.D, regarding the impact of the Nuclear Regulatory Comission's (NRC) regulations on the practice of phamacy.
We appreciate this opportunity to explain NRC's role in the regulation of nucle,ar pharmacies.
NRC has legislative authority to license and regulate all aspects of the possession and use of byproduct (i.e., reactor-produced) materials, including radiopharmaceuticals, in order to protect health and minimize danger to life or property.
The Food and Drug Administration (FDA) has legislative authority to regulate the manufacture, sale and distribution of drugs, including radiopharmaceuticals, in order to provide reasonable assurance of safety and effectiveness.
In the case of radioactive drugs, both FDA and NRC have regulatory responsibilities.
In 1975 FDA terminated an existing exemption for those radiophamaceu-ticals previously regulated by the Atomic Energy Commission (AEC). At that time, AEC withdrew from regulation of the safety and effectiveness of radiopharmaceuticals with respcct to the patient in order to prevent dual regulation.
Since then, NRC medical licensees have been authorized to receive only FDA-approved radiophamaceuticals.
In the context of this letter, the phrase "FDA-approved" refers to FDA's apprcval of a "New Drug Application" (NDA) or FDA's acceptance of a " Notice of Claimed Investigational Exemption for a New Drug" (IND).
NRC has issued licenses to nuclear phamacies authorizing them to provide FDA-approved radioactive drugs to NRC and Agreement State medical licensees.
Basically, NRC's regulations have very little effect on State control of the practice of phamacy.
NRC will not license a nuclear pharmacy unless it has already been licensed by the State for the practice of pharmacy.
It should be noted that the primary con-sideration of the State is whether phamacy personnel have adequate training and experience to compound drugs.
The state generally does not consider the same issues as does NRC (i.e., radiation safety).
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The Honorable Henry Bellmon NRC will license a nuclear pharmacy to prepare and distribute only those radiopharmaceuticals that have been approved or accepted ty FDA.
In most instances, the nuclear phannacy purchases FDA-approved radiopharma-ceuticals or FDA-approved radionuclide generators and reagent kits, and then prepares individual patient doses that are ready for injection or oral administration. Less frequently, the nuclear pharmacy may obtain FDA-approval for its own preparations or it may prepare radiopharmaceuticals for individual physicians who have obtained FDA-approval for their own products.
FDA will approve a radiopharmaceutical for routine use (i.e., approve an NDA) if the sponsor meets quality control standards and the sponsor has demonstrated substantial evidence of safety and effectiveness of a radiopharmaceutical. When the safety and effectiveness of a radiophanna-ceutical have not been established, FDA will accept the radioactive drug for investigational use (i.e., accept an IND) if the sponsor has established certain criteria for safeguarding patients.
FDA approval of products distributed by nuclear phannacies has always been a condition of the phannacy's NRC license.
NRC has recently published a statement of general policy on the medical use of isotopes (copy enclosed) which is consistent with this regulatory approach to nuclear phannacies. The second part of the statement reads:
The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
In summary, we do not believe that NRC's regulation of the nuclear portion of a State-approved pharmacy is too restrictive.
Nuclear phannacies may distribute FDA-approved radioactive drugs.
We do not believe that it would be in the best interest of public health c.nd safety to authorize nuclear pharmacies to distribute radioactive drugs that have not been approved or accepted by FDA because FDA is the Federal agency responsible for drug safety and effectiveness.
I trust that I have answered your inquiry.
If you have further questions please contact me again or call Mr. Vandy L. Miller, Chief of the License Management Branch, Office of Nuclear Material Safety and Safeguards, at (301) 427-4232.
rSincerely,
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,Msep'h M. Hendrie Chairman
Enclosure:
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