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Section 1306 > Section 1306.11
Section 1306.11 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a
prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant
to a written prescription signed by the practitioner, except as provided in paragraph (d) of this
section. A prescription for a Schedule II controlled substance may be transmitted by the
practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the
original written, signed prescription is presented to the pharmacist for review prior to the actual
dispensing of the controlled substance, except as noted in paragraph (e),
(f), or (g) of this section.
The original prescription shall be maintained in accordance with Sec. 1304.04(h) of this chapter.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in
Schedule II in the course of his professional practice without a prescription, subject to
Sec.
1306.07.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a
controlled substance listed in Schedule II only pursuant to a written prescription signed by the
prescribing individual practitioner or to an order for medication made by an individual
practitioner which is dispensed for immediate administration to the ultimate user.
(d) In the case of an emergency situation, as defined by the Secretary in Sec. 290.10 of this title, a
pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral
authorization of a prescribing individual practitioner, provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate to treat
the patient during the emergency period (dispensing beyond the emergency period
must be pursuant to a written prescription signed by the prescribing individual
practitioner);
(2) The prescription shall be immediately reduced to writing by the pharmacist and
shall contain all information required in Sec. 1306.05, except for the signature of
the prescribing individual practitioner;
(3) If the prescribing individual practitioner is not known to the pharmacist, he must
make a reasonable effort to determine that the oral authorization came from a
registered individual practitioner, which may include a callback to the prescribing
individual practitioner using his phone number as listed in the telephone directory
and/or other good faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription, the prescribing
individual practitioner shall cause a written prescription for the emergency quantity
prescribed to be delivered to the dispensing pharmacist. In addition to conforming
to the requirements of Sec. 1306.05, the prescription shall have written on its face
"Authorization for Emergency Dispensing," and the date of the oral order. The
written prescription may be delivered to the pharmacist in person or by mail, but if
delivered by mail it must be postmarked within the 7 day period. Upon receipt, the
dispensing pharmacist shall attach this prescription to the oral emergency
prescription which had earlier been reduced to writing. The pharmacist shall notify
the nearest office of the Administration if the prescribing individual practitioner
fails to deliver a written prescription to him; failure of the pharmacist to do so shall
void the authority conferred by this paragraph to dispense without a written
prescription of a prescribing individual practitioner.
(5) Central fill pharmacies shall not be authorized under this
paragraph to prepare prescriptions for a controlled substance listed
in Schedule II upon receiving an oral authorization from a retail
pharmacist or an individual practitioner.
(e) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic
substance to be compounded for the direct administration to a patient by
parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the
practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written
prescription for purposes of this paragraph (e) and it shall be maintained in accordance with
Sec. 1304.04(h) of this chapter.
(f) A prescription prepared in accordance with Sec. 1306.05 written for Schedule II substance for
a resident of a Long Term Care Facility may be transmitted by the practitioner or the
practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original
written prescription for purposes of this paragraph (f) and it shall be maintained in accordance
with Sec. 1304.04(h).
(g) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic
substance for a patient enrolled
in a hospice
care program
certified
and/or paid for
by Medicare under Title XVIII or
a hospice program which is
licensed
by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing
pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription
that the patient is a hospice patient. The facsimile serves as the original written prescription for
purposes of this paragraph (g) and it shall be maintained in accordance with ยง
1304.04(h) of
this chapter.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR
26609, Sept. 24, 1973 and amended at 53 FR 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994;
59 FR 30832, June 15, 1994; 62 FR 13964, Mar. 24, 1997;
65 FR 45713 July 25, 2000; 68 FR 37410, June 24, 2003]
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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