Regulations &
Codified CSA > CFR > Section
1301 > Section 1301.74
Section 1301.74 Other security controls for non-practitioners;
narcotic treatment programs and compounders for narcotic
treatment programs.
(a) Before distributing a controlled substance to any person who the registrant does not know to
be registered to possess the controlled substance, the registrant shall make a good faith inquiry
either with the Administration or with the appropriate State controlled substances registration
agency, if any, to determine that the person is registered to possess the controlled substance.
(b) The registrant shall design and operate a system to disclose to the registrant suspicious orders
of controlled substances. The registrant shall inform the Field Division Office of the
Administration in his area of suspicious orders when discovered by the registrant. Suspicious
orders include orders of unusual size, orders deviating substantially from a normal pattern, and
orders of unusual frequency.
(c)
The registrant shall notify the Field Division Office of the Administration in his area
, in writing, of any
theft or significant loss of any controlled substances within one business day of discovery of such theft or loss. The
supplier is responsible for reporting in-transit losses of controlled substances by the
common or contract carrier selected pursuant to paragraph (e) of this
section, within one business day of discovery
of such theft or
loss. The registrant shall also complete, and submit to the Field
Division Office in his area,
DEA Form 106 regarding the
theft or loss. Thefts and significant losses must
be reported whether or not the controlled substances are subsequently recovered or
the
responsible parties are identified and action taken against them. When determining whether a loss is
significant, a registrant should consider, among others, the following
factors:
(1) The actual quantity of controlled substances lost in relation to the
type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with
access to those controlled substances by specific individuals, or whether
the loss can be attributed to unique activities that may take place
involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses
appear to be random, and the results of efforts taken to resolve the losses;
and, if known,
(5) Whether the specific controlled substances are likely candidates for
diversion;
(6) Local trends and other indicators of the diversion potential of the
missing controlled substance.
(d) The registrant shall not distribute any controlled substance listed in Schedules II through V as
a complimentary sample to any potential or current customer (1) without the prior written request
of the customer, (2) to be used only for satisfying the legitimate medical needs of patients of the
customer, and (3) only in reasonable quantities. Such request must contain the name, address,
and registration number of the customer and the name and quantity of the specific controlled
substance desired. The request shall be preserved by the registrant with other records of
distribution of controlled substances. In addition, the requirements of part 1305 of the chapter
shall be complied with for any distribution of a controlled substance listed in Schedule II. For
purposes of this paragraph, the term "customer" includes a person to whom a complimentary
sample of a substance is given in order to encourage the prescribing or recommending of the
substance by the person.
(e) When shipping controlled substances, a registrant is responsible for selecting common or
contract carriers which provide adequate security to guard against in-transit losses. When storing
controlled substances in a public warehouse, a registrant is responsible for selecting a
warehouseman which will provide adequate security to guard against storage losses; wherever
possible, the registrant shall store controlled substances in a public warehouse which complies
with the requirements set forth in Sec. 1301.72. In addition, the registrant shall employ
precautions (e.g., assuring that shipping containers do not indicate that contents are controlled
substances) to guard against storage or in-transit losses.
(f) When distributing controlled substances through agents (e.g.,
detailmen), a registrant is
responsible for providing and requiring adequate security to guard against theft and diversion
while the substances are being stored or handled by the agent or agents.
(g) Before the initial distribution of carfentanil etorphine hydrochloride and/or diprenorphine to
any person, the registrant must verify that the person is authorized to handle the
substances(s) by
contacting the Drug Enforcement Administration.
(h) The acceptance of delivery of narcotic substances by a narcotic treatment program shall be
made only by a licensed practitioner employed at the facility or other authorized individuals
designated in writing. At the time of delivery, the licensed practitioner or other authorized
individual designated in writing (excluding persons currently or previously dependent on narcotic
drugs), shall sign for the narcotics and place his specific title (if any) on any invoice. Copies of
these signed invoices shall be kept by the distributor.
(i) Narcotics dispensed or administered at a narcotic treatment program will be dispensed or
administered directly to the patient by either (1) the licensed practitioner, (2) a registered nurse
under the direction of the licensed practitioner, (3) a licensed practical nurse under the direction
of the licensed practitioner, or (4) a pharmacist under the direction of the licensed practitioner.
(j) Persons enrolled in a narcotic treatment program will be required to wait in an area physically
separated from the narcotic storage and dispensing area. This requirement will be enforced by the
program physician and employees.
(k) All narcotic treatment programs must comply with standards established by the Secretary of
Health and Human Services (after consultation with the Administration) respecting the quantities
of narcotic drugs which may be provided to persons enrolled in a narcotic treatment program for
unsupervised use.
(l) DEA may exercise discretion regarding the degree of security required in narcotic treatment
programs based on such factors as the location of a program, the number of patients enrolled in a
program and the number of physicians, staff members and security guards. Similarly, such factors
will be taken into consideration when evaluating existing security or requiring new security at a
narcotic treatment program.
[36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, 1971, as amended at 36 FR 18731, Sept. 21,
1971. Redesignated at 38 FR 26609, Sept. 24, 1973]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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