Regulations &
Codified CSA > CFR > Section
1301 > Section 1301.28
§1301.28 - Exemption from separate registration for practitioners
dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs
approved by the Food and Drug Administration specifically for use in
maintenance or detoxification treatment.
This page includes changes
to the Code of Federal Regulations since April 1, 2008. View
Key.
(a) An individual practitioner may dispense or prescribe Schedule III, IV,
or V narcotic controlled drugs or combinations of narcotic controlled drugs
which have been approved by the Food and Drug Administration (FDA)
specifically for use in maintenance or detoxification treatment without
obtaining the separate registration required by §1301.13(e) if all of the
following conditions are met:
(1) The individual practitioner meets the conditions specified in paragraph
(b) of this section.
(2) The narcotic drugs or combination of narcotic drugs meet the conditions
specified in paragraph (c) of this section.
[[Page 36343]]
(3) The individual practitioner is in compliance with either paragraph (d)
or paragraph (e) of this section.
(b)(1) The individual practitioner must submit notification to the
Secretary of Health and Human Services stating the individual practitioner's
intent to dispense or prescribe narcotic drugs under paragraph (a) of this
section. The notice must contain all of the following certifications:
(i) The individual practitioner is registered under §1301.13
as an individual practitioner and is a "qualifying physician'' as defined
in section 303(g)(2)(G) of the Act (21
U.S.C. 823(g)(2)(G)).
(ii) The individual practitioner has the capacity to refer the patients to
whom the individual practitioner will provide narcotic drugs or combinations
of narcotic drugs for appropriate counseling and other appropriate ancillary
services.
(iii) Where the individual practitioner is not a member of a group
practice, the total number of such patients of the individual practitioner
will not exceed 30 at any one time, unless regulations promulgated by the
Secretary of Health and Human Services are modified.
The total number of patients to whom the individual
practitioner will provide narcotic drugs or combinations of
narcotic drugs under this section will not exceed 30 at any one
time unless, not sooner than 1 year after the date on which the
practitioner submitted the initial notification to the Secretary
of Health and Human Services, the practitioner submits a second
notification to the Secretary of the need and intent of the
practitioner to treat up to 100 patients. A second notification
under this subparagraph shall contain the certifications
required by subparagraphs (i) and (ii) of this paragraph. The
Secretary of Health and Human Services may promulgate
regulations to change the total number of patients.
(iv) Where the individual practitioner is a member of a group practice, the
total number of such patients of the group practice will not exceed 30 at any
one time, unless regulations promulgated by the Secretary of Health and Human
Services are modified.
(2) If an individual practitioner wishes to prescribe or dispense narcotic
drugs pursuant to paragraph (e) of this section, the individual practitioner
must provide the Secretary of Health and Human Services the following:
(i) Notification as required under paragraph (b)(1) of this section in
writing, stating the individual practitioner's name and DEA registration
number issued under §1301.13.
(ii) If the individual practitioner is a member of a group practice, the
names of the other individual practitioners in the group and the DEA
registration numbers issued to the other individual practitioners under §1301.13.
(c) The narcotic drugs or combination of narcotic drugs to be dispensed or
prescribed under this section must meet all of the following conditions:
(1) The drugs or combination of drugs have been approved for use in
"maintenance treatment'' or "detoxification treatment'' under the
Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health
Service Act.
(2) The drugs or combination of drugs have not been the subject of an
adverse determination by the Secretary of Health and Human Services, after
consultation with the Attorney General, that the use of the drugs or
combination of drugs requires additional standards respecting the
qualifications of practitioners or the quantities of the drugs that may be
provided for unsupervised use.
(d)(1) After receiving the notification submitted under paragraph (b) of
this section, the Secretary of Health and Human Services will forward a copy
of the notification to the Administrator. The Secretary of Health and Human
Services will have 45 days from the date of receipt of the notification to
make a determination of whether the individual practitioner involved meets all
requirements for a waiver under section 303(g)(2)(B) of the Act (21 U.S.C.
823(g)(2)(B)). Health and Human Services will notify DEA of its determination
regarding the individual practitioner. If the individual practitioner has the
appropriate registration under §1301.13, then the Administrator will issue
the practitioner an identification number as soon as one of the following
conditions occurs:
(i) The Administrator receives a positive determination from the Secretary
of Health and Human Services before the conclusion of the 45- day review
period, or
(ii) The 45-day review period has concluded and no determination by the
Secretary of Health and Human Services has been made.
(2) If the Secretary denies certification to an individual practitioner or
withdraws such certification once it is issued, then DEA will not issue the
individual practitioner an identification number, or will withdraw the
identification number if one has been issued.
(3) The individual practitioner must include the identification number on
all records when dispensing and on all prescriptions when prescribing narcotic
drugs under this section.
(e) An individual practitioner may begin to prescribe or dispense narcotic
drugs to a specific individual patient under this section before receiving an
identification number from the Administrator if the following conditions are
met:
(1) The individual practitioner has submitted a written notification under
paragraph (b) of this section in good faith to the Secretary of Health and
Human Services.
(2) The individual practitioner reasonably believes that the conditions
specified in paragraphs (b) and (c) of this section have been met.
(3) The individual practitioner reasonably believes that the treatment of
an individual patient would be facilitated if narcotic drugs are prescribed or
dispensed under this section before the sooner of: (i) Receipt of an
identification number from the Administrator, or
(ii) Expiration of the 45-day period.
(4) The individual practitioner has notified both the Secretary of Health
and Human Services and the Administrator of his or her intent to begin
prescribing or dispensing the narcotic drugs before expiration of the 45-day
period.
(5) The Secretary has not notified the registrant that he/she is not
qualified under paragraph (d) of this section.
(6) The individual practitioner has the appropriate registration under
§1301.13.
(f) If an individual practitioner dispenses or prescribes Schedule III, IV,
or V narcotic drugs approved by the Food and Drug Administration specifically
for maintenance or detoxification treatment in violation of any of the
conditions specified in paragraphs (b), (c) or (e) of this section, the
Administrator may revoke the individual practitioner's registration in
accordance with §1301.36.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
|