Fed Register, Oct 6 2010, Vol. 75 No. 193: DEA 21 CFR Part 1306 [Docket No. DEA-339s

Fed Register, Oct 6 2010, Vol. 75 No. 193

 

http://www.pharmacy.state.mn.us/documents/agentDEA.pdf

Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA–339S]

The statute defines an
‘‘agent’’ as ‘‘an authorized person who
acts on behalf of or at the direction of
a manufacturer, distributor, or
dispenser. * * *.’’ 21 U.S.C. 802(3).
Likewise, DEA regulations
implementing the CSA specifically
permit a practitioner to use an
authorized agent to perform certain
ministerial acts in connection with
communicating prescription
information to a pharmacy.

To be effective (i.e., valid), a
prescription for a controlled substance
must be issued for a legitimate medical
purpose by a practitioner acting in the
usual course of professional practice.

United States v. Moore, 423 U.S. 122
(1975); 21 CFR 1306.04(a).

Thus, the
practitioner must determine that a
prescription for a controlled substance
is for a legitimate medical purpose.

While the core responsibilities
pertaining to prescribing controlled
substances may not be delegated to
anyone else
, an individual practitioner
may authorize an agent to perform a
limited role in communicating such
prescriptions to a pharmacy in order to
make the prescription process more
efficient. Nonetheless, it is important to
understand that any agency relationship
must also preserve the requirement that
medical determinations to prescribe
controlled substances be made by a
practitioner only,
not by an agent.

See: Elements of a Valid Prescription Must be Specified by the Practitioner and
Cannot be Delegated;
and Role of Agent Under the CSA.

Discussion

One thought on “Fed Register, Oct 6 2010, Vol. 75 No. 193: DEA 21 CFR Part 1306 [Docket No. DEA-339s

  1. super text

    Posted by TavaExcex | November 8, 2012, 7:21 pm

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