(a) The requirement of registration is waived for persons administering the drug product DaTscan\TM\ to a patient for diagnostic purposes if the person is authorized by a valid medical use license or permit issued by the United States Nuclear Regulatory Commission (NRC) or NRC master materials licensee or an agreement state authorizing the person to receive, possess, use, or transfer byproduct material in accordance with NRC or agreement state rules and regulations.
(1) As used in this section, ``agreement state'' is any state with which the NRC or the Atomic Energy Commission has entered into an effective agreement under Section 274(b) of the Atomic Energy Act of 1954, as amended. As of October 2014, those states considered ``non-agreement states'' include: Alaska, Connecticut, Delaware, Hawaii, Idaho, Indiana, Michigan, Missouri, Montana, South Dakota, Vermont, Washington, DC, West Virginia, and Wyoming. All other states have entered into agreements with the NRC.
(2) This section does not exempt persons identified in this paragraph (a) from any statutory or regulatory requirements pertaining to any controlled substance other than the drug product DaTscan\TM\.
(3) This section does not exempt from the requirement of registration persons who prescribe, or order the administration of, the drug product DaTscan\TM\.
(b) Persons identified in paragraph (a) of this section are exempt from application of 21 U.S.C. 822(a)(2), 827, and 828 (registration, records, reports, and order forms) and sections 1301.71, 1301.75, and 1301.76 of this chapter (practitioner security), to the extent described in paragraphs (e) and (f) of this section, only with respect to administering the drug product DaTscan\TM\.
(c) The drug product DaTscan\TM\ is exempt from application of 21 U.S.C. 825 and Sec. 1302.03 of this chapter to the extent described in paragraph (d) of this section.
(d) Labeling and packaging. In lieu of the requirements set forth in part 1302 of this chapter, the label and the packaging of the drug product DaTscan\TM\ must be prominently marked with its full trade name or other description and the name of the manufacturer in such a way that the product can be readily identified as the drug product DaTscan\TM\. The symbol designating the schedule of the drug product DaTscan\TM\ is not required on either the label or the packaging of the drug product DaTscan\TM\.
(e) Registration and security. Any person who manufactures or distributes the drug product DaTscan\TM\ must be registered under the Act and comply with all relevant security requirements regarding the schedule II controlled substances being distributed or used in the manufacturing process. Any person identified in paragraph (a) of this section is not required to be registered under the Act to handle the drug product DaTscan\TM\, and these persons are not required to store the drug product DaTscan\TM\ in accordance with security requirements regarding controlled substances.
(f) Records and reports. Any person who manufactures or distributes the drug product DaTscan\TM\ must keep complete and accurate records and file all reports required under part 1304 of this chapter regarding all controlled substances distributed or used in the manufacturing process for the drug product DaTscan\TM\. In reports required by 21 CFR 1304.33 due to transactions with persons identified in paragraph (a) of this section, the DEA registration number of the person identified in paragraph (a) is not required to be reported. Any person identified in paragraph (a) who handles the drug product DaTscan\TM\ is not required to maintain records or file reports required by the Act or its implementing regulations. The authorizing practitioner shall prepare a record containing the practitioner's name, signature, date of authorization, DEA registration number, drug product name, and patient name, and provide this record to the patient. This record prepared by the DEA registered practitioner shall be used as the distributor's record of the distribution.
(g) Criminal penalties No exemption granted pursuant to this section affects the criminal liability for illegal manufacture, distribution, or possession of controlled substances contained in the drug product DaTscan\TM\. Use of the drug product DaTscan\TM\ is lawful for registrants and nonregistrants only as long as such activity is intended for administration for diagnostic purposes.
(h) The persons identified in paragraph (a) of this section shall return all unused drug product DaTscan\TM\ to the DEA-registered distributor from whom the person received it, for disposal in accordance with 10 CFR 20.2001-20.2008.
(i) Once the drug product DaTscan\TM\ is returned to the appropriate DEA-registered distributor, it shall be disposed of in accordance with the following procedures:
(1) The DEA-registered distributor shall keep a record of the return;
(2) After receipt of the drug product DaTscan\TM\, the DEA-registered distributor shall hold the drug product DaTscan\TM\ until it is no longer considered low-level radioactive waste in accordance with 10 CFR 20.2001(a)(2); and
(3) After the drug product DaTscan\TM\ is no longer considered low-level radioactive waste, the DEA-registered distributor shall dispose of all unused DaTscan\TM\ in accordance with 21 CFR part 1317.
(j) The exemptions specified in this section are not applicable to the drug product DaTscan\TM\ if there are any changes in the quantitative or qualitative composition of the preparation or mixture after the date of this regulation, or change in the trade name or other designation of the drug product DaTscan\TM\. [79 FR 70089, Nov. 25, 2014]
Action on Application for Registration: Revocation or Suspension of
Registration