Health Law Daily Drug used to make fentanyl may become a controlled substance
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Tuesday, September 17, 2019

Drug used to make fentanyl may become a controlled substance

By Cathleen Calhoun, J.D.

DEA proposes changing the status of norfentanyl to slow an "unprecedented outbreak of thousands of fentanyl-related overdoses."

Drug Enforcement Agency (DEA) believes that the control of norfentanyl is necessary to prevent its production and use in the illicit production of fentanyl. As a result, DEA is proposing the designation of the drug norfentanyl, as an immediate precursor of fentanyl, a schedule II controlled substance. The agency is seeking comments on its proposal through November 18, 2019, and is encouraging electronic comments through the Federal eRulemaking Portal (http://www.regulations.gov ) that provides the ability to type short comments directly into the comment field on the webpage or attach a file for lengthier comments. Comments may be shielded from the public by including the phrase "Confidential Business Information" in the first paragraph (Notice, 84 FR 48815, September 17, 2019).

Role of Norfentanyl in the Synthesis of Fentanyl. Since fentanyl is not a naturally occurring substance, the manufacture of it requires it to be produced through synthetic organic chemistry. According to DEA, law enforcement information indicates that illicit manufacturers of fentanyl have been using norfentanyl, and avoiding other routes to create fentanyl, such as N-phenethyl-4-piperidone (NPP) and 4-anilino-N-phenethylpiperidine (ANPP) in response to regulations placed on those other methods. The DEA noted that it is not aware of any legitimate uses of norfentanyl other than in the synthesis of fentanyl.

Results of change. If norfentanyl were scheduled as an immediate precursor of the schedule II controlled substance, fentanyl, it would subject norfentanyl to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, and exporting of a schedule II controlled substance. If norfentanyl is placed in schedule II, the regulatory requirements would include the following:

  1. Registration. Any person who manufacture, distributes, dispenses, imports, or exports norfentanyl, engages in research with respect to norfentanyl, or proposes to engage in such activities would be required to apply and be accepted for schedule II registration (21 CFR part 1301).
  2. Security. Norfentanyl would have to be manufactured, distributed, and stored in accordance with the standards for physical security and the operating procedures set forth by regulations (21 CFR part 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76, and 1301.77).
  3. Labeling and Packaging. All labels and labeling for commercial containers of norfentanyl that are distributed would be required to comply with regulations (21 CFR part 1302.03 – 1302.07.
  4. Quotas. Quotas for norfentanyl would be established pursuant to 21 CFR part 1302.03.
  5. Inventory. Every registrant would be required to keep an inventory of its stock of the substance on hand pursuant to 21 CFR part 1304.03, 1303.04 and 1303.11.
  6. Records and Reports. Every DEA registrant would be required to keep records and send reports pursuant to 21 U.S.C 827.
  7. Order forms. Order forms would have to comply with regulatory requirements pursuant to 21 U.S.C 828.
  8. Importation and Exportation. All imports and exports of the drug would have to meet regulatory requirements (21 U.S.C. 952, 953, and 958).
  9. Liability. Criminal penalties could apply for any activity with norfentanyl in violation of or not authorized under the Controlled Substances Act or the Controlled Substances Import and Export Act.

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