[Title 21 CFR 1306]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1306 - PRESCRIPTIONS]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS92002-04-012002-04-01falsePRESCRIPTIONS1306PART 1306FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
PART 1306--PRESCRIPTIONS--Table of Contents
General Information
Sec.
1306.01 Scope of part 1306.
1306.02 Definitions.
1306.03 Persons entitled to issue prescriptions.
1306.04 Purpose of issue of prescription.
1306.05 Manner of issuance of prescriptions.
1306.06 Persons entitled to fill prescriptions.
1306.07 Administering or dispensing of narcotic drugs.
Controlled Substances Listed in Schedule II
1306.11 Requirement of prescription.
1306.12 Refilling prescriptions.
1306.13 Partial filling of prescriptions.
1306.14 Labeling of substances and filling of prescriptions.
Controlled Substances Listed in Schedules III, IV, and V
1306.21 Requirement of prescription.
1306.22 Refilling of prescriptions.
1306.23 Partial filling of prescriptions.
1306.24 Labeling of substances and filling of prescriptions.
1306.25 Transfer between pharmacies of presription information for
Schedules III, IV, and V controlled substances for refill
purposes.
1306.26 Dispensing without prescription.
Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.
Source: 36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971,
unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.
General Information
Sec. 1306.01 Scope of part 1306.
Rules governing the issuance, filling and filing of prescriptions
pursuant to section 309 of the Act (21 U.S.C. 829) are set forth
generally in that section and specifically by the sections of this part.
Sec. 1306.02 Definitions.
Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
[62 FR 13964, Mar. 24, 1997]
Sec. 1306.03 Persons entitled to issue prescriptions.
(a) A prescription for a controlled substance may be issued only by
an individual practitioner who is:
(1) Authorized to prescribe controlled substances by the
jurisdiction in which he is licensed to practice his profession and
(2) Either registered or exempted from registration pursuant to
Secs. 1301.22(c) and 1301.23 of this chapter.
[[Page 71]]
(b) A prescription issued by an individual practitioner may be
communicated to a pharmacist by an employee or agent of the individual
practitioner.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966,
Mar. 24, 1997]
Sec. 1306.04 Purpose of issue of prescription.
(a) A prescription for a controlled substance to be effective must
be issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice. The
responsibility for the proper prescribing and dispensing of controlled
substances is upon the prescribing practitioner, but a corresponding
responsibility rests with the pharmacist who fills the prescription. An
order purporting to be a prescription issued not in the usual course of
professional treatment or in legitimate and authorized research is not a
prescription within the meaning and intent of section 309 of the Act (21
U.S.C. 829) and the person knowingly filling such a purported
prescription, as well as the person issuing it, shall be subject to the
penalties provided for violations of the provisions of law relating to
controlled substances.
(b) A prescription may not be issued in order for an individual
practitioner to obtain controlled substances for supplying the
individual practitioner for the purpose of general dispensing to
patients.
(c) A prescription may not be issued for the dispensing of narcotic
drugs listed in any schedule for ``detoxification treatment'' or
``maintenance treatment'' as defined in Section 102 of the Act (21
U.S.C. 802).
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 39 FR 37986, Oct. 25, 1974]
Sec. 1306.05 Manner of issuance of prescriptions.
(a) All prescriptions for controlled substances shall be dated as
of, and signed on, the day when issued and shall bear the full name and
address of the patient, the drug name, strength, dosage form, quantity
prescribed, directions for use and the name, address and registration
number of the practitioner. A practitioner may sign a prescription in
the same manner as he would sign a check or legal document (e.g., J.H.
Smith or John H. Smith). Where an oral order is not permitted,
prescriptions shall be written with ink or indelible pencil or
typewriter and shall be manually signed by the practitioner. The
prescriptions may be prepared by the secretary or agent for the
signature of a practitioner, but the prescribing practitioner is
responsible in case the prescription does not conform in all essential
respects to the law and regulations. A corresponding liability rests
upon the pharmacist who fills a prescription not prepared in the form
prescribed by these regulations.
(b) An individual practitioner exempted from registration under
Sec. 1301.22(c) of this chapter shall include on all prescriptions
issued by him or her the registration number of the hospital or other
institution and the special internal code number assigned to him or her
by the hospital or other institution as provided in Sec. 1301.22(c) of
this chapter, in lieu of the registration number of the practitioner
required by this section. Each written prescription shall have the name
of the physician stamped, typed, or handprinted on it, as well as the
signature of the physician.
(c) An official exempted from registration under Sec. 1301.22(c)
shall include on all prescriptions issued by him his branch of service
or agency (e.g., ``U.S. Army'' or ``Public Health Service'') and his
service identification number, in lieu of the registration number of the
practitioner required by this section. The service identification number
for a Public Health Service employee is his Social Security
identification number. Each prescription shall have the name of the
officer stamped, typed, or handprinted on it, as well as the signature
of the officer.
[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 56 FR 25026,
June 3, 1991; 60 FR 36641, July 18, 1995; 62 FR 13966, Mar. 24, 1997]
[[Page 72]]
Sec. 1306.06 Persons entitled to fill prescriptions.
A prescription for controlled substances may only be filled by a
pharmacist acting in the usual course of his professional practice and
either registered individually or employed in a registered pharmacy or
registered institutional practitioner.
Sec. 1306.07 Administering or dispensing of narcotic drugs.
(a) The administering or dispensing directly (but not prescribing)
of narcotic drugs listed in any schedule to a narcotic drug dependent
person for ``detoxification treatment'' or ``maintenance treatment'' as
defined in section 102 of the Act (21 U.S.C. 802) shall be deemed to be
within the meaning of the term ``in the course of his professional
practice or research'' in section 308(e) and section 102(20) of the Act
(21 U.S.C. 828 (e)): Provided, That the practitioner is separately
registered with the Attorney General as required by section 303(g) of
the Act (21 U.S.C. 823(g)) and then thereafter complies with the
regulatory standards imposed relative to treatment qualification,
security, records and unsupervised use of drugs pursuant to such Act.
(b) Nothing in this section shall prohibit a physician who is not
specifically registered to conduct a narcotic treatment program from
administering (but not prescribing) narcotic drugs to a person for the
purpose of relieving acute withdrawal symptoms when necessary while
arrangements are being made for referral for treatment. Not more than
one day's medication may be administered to the person or for the
person's use at one time. Such emergency treatment may be carried out
for not more than three days and may not be renewed or extended.
(c) This section is not intended to impose any limitations on a
physician or authorized hospital staff to administer or dispense
narcotic drugs in a hospital to maintain or detoxify a person as an
incidental adjunct to medical or surgical treatment of conditions other
than addiction, or to administer or dispense narcotic drugs to persons
with intractable pain in which no relief or cure is possible or none has
been found after reasonable efforts.
[39 FR 37986, Oct. 25, 1974]
Controlled Substances Listed in Schedule II
Sec. 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);
[[Page 73]]
(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.
(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
Sec. 1304.04(h).
[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]
Sec. 1306.12 Refilling prescriptions.
The refilling of a prescription for a controlled substance listed in
Schedule II is prohibited.
Sec. 1306.13 Partial filling of prescriptions.
(a) The partial filling of a prescription for a controlled substance
listed in Schedule II is permissible, if the pharmacist is unable to
supply the full quantity called for in a written or emergency oral
prescription and he makes a notation of the quantity supplied on the
face of the written prescription (or written record of the emergency
oral prescription). The remaining portion of the prescription may be
filled within 72 hours of the first partial filling; however, if the
remaining portion is not or cannot be filled within the 72-hour period,
the pharmacist shall so notify the prescribing individual practitioner.
No
[[Page 74]]
further quantity may be supplied beyond 72 hours without a new
prescription.
(b) A prescription for a Schedule II controlled substance written
for a patient in a Long Term Care Facility (LTCF) or for a patient with
a medical diagnosis documenting a terminal illness may be filled in
partial quantities to include individual dosage units. If there is any
question whether a patient may be classified as having a terminal
illness, the pharmacist must contact the practitioner prior to partially
filling the prescription. Both the pharmacist and the prescribing
practitioner have a corresponding responsibility to assure that the
controlled substance is for a terminally ill patient. The pharmacist
must record on the prescription whether the patient is ``terminally
ill'' or an ``LTCF patient.'' A prescription that is partially filled
and does not contain the notation ``terminally ill'' or ``LTCF patient''
shall be deemed to have been filled in violation of the Act. For each
partial filling, the dispensing pharmacist shall record on the back of
the prescription (or on another appropriate record, uniformly
maintained, and readily retrievable) the date of the partial filling,
quantity dispensed, remaining quantity authorized to be dispensed, and
the identification of the dispensing pharmacist. The total quantity of
Schedule II controlled substances dispensed in all partial fillings must
not exceed the total quantity prescribed. Schedule II prescriptions for
patients in a LTCF or patients with a medical diagnosis documenting a
terminal illness shall be valid for a period not to exceed 60 days from
the issue date unless sooner terminated by the discontinuance of
medication.
(c) Information pertaining to current Schedule II prescriptions for
patients in a LTCF or for patients with a medical diagnosis documenting
a terminal illness may be maintained in a computerized system if this
system has the capability to permit:
(1) Output (display or printout) of the original prescription
number, date of issue, identification of prescribing individual
practitioner, identification of patient, address of the LTCF or address
of the hospital or residence of the patient, identification of
medication authorized (to include dosage, form, strength and quantity),
listing of the partial fillings that have been dispensed under each
prescription and the information required in Sec. 1306.13(b).
(2) Immediate (real time) updating of the prescription record each
time a partial filling of the prescription is conducted.
(3) Retrieval of partially filled Schedule II prescription
information is the same as required by Sec. 1306.22(b) (4) and (5) for
Schedule III and IV prescription refill information.
(Authority: 21 U.S.C. 801, et seq.)
[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973,
and amended at 45 FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62
FR 13965, Mar. 24, 1997]
Sec. 1306.14 Labeling of substances and filling of prescriptions.
(a) The pharmacist filling a written or emergency oral prescription
for a controlled substance listed in Schedule II shall affix to the
package a label showing date of filling, the pharmacy name and address,
the serial number of the prescription, the name of the patient, the name
of the prescribing practitioner, and directions for use and cautionary
statements, if any, contained in such prescription or required by law.
(b) The requirements of paragraph (a) of this section do not apply
when a controlled substance listed in Schedule II is prescribed for
administration to an ultimate user who is institutionalized: Provided,
That:
(1) Not more than 7-day supply of the controlled substance listed in
Schedule II is dispensed at one time;
(2) The controlled substance listed in Schedule II is not in the
possession of the ultimate user prior to the administration;
(3) The institution maintains appropriate safeguards and records
regarding the proper administration, control, dispensing, and storage of
the controlled substance listed in Schedule II; and
(4) The system employed by the pharmacist in filling a prescription
is adequate to identify the supplier, the product, and the patient, and
to set
[[Page 75]]
forth the directions for use and cautionary statements, if any,
contained in the prescription or required by law.
(c) All written prescriptions and written records of emergency oral
prescriptions shall be kept in accordance with requirements of
Sec. 1304.04(h) of this chapter.
[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972.
Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13965,
Mar. 24, 1997]
Controlled Substances Listed in Schedules III, IV, and V
Sec. 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed
in Schedule III, IV, or V which is a prescription drug as determined
under the Federal Food, Drug, and Cosmetic Act, only pursuant to either
a written prescription signed by a practitioner or a facsimile of a
written, signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy or pursuant to an oral prescription
made by an individual practitioner and promptly reduced to writing by
the pharmacist containing all information required in Sec. 1306.05,
except for the signature of the practitioner.
(b) An individual practitioner may administer or dispense directly a
controlled substance listed in Schedule III, IV, or V in the course of
his/her 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
III, IV, or V only pursuant to a written prescription signed by an
individual practitioner, or pursuant to a facsimile of a written
prescription or order for medication transmitted by the practitioner or
the practitioner's agent to the institutional practitioner-pharmacist,
or pursuant to an oral prescription made by an individual practitioner
and promptly reduced to writing by the pharmacist (containing all
information required in Section 1306.05 except for the signature of the
individual practitioner), or pursuant to an order for medication made by
an individual practitioner which is dispensed for immediate
administration to the ultimate user, subject to Sec. 1306.07.
[62 FR 13965, Mar. 24, 1997]
Sec. 1306.22 Refilling of prescriptions.
(a) No prescription for a controlled substance listed in Schedule
III or IV shall be filled or refilled more than six months after the
date on which such prescription was issued and no such prescription
authorized to be refilled may be refilled more than five times. Each
refilling of a prescription shall be entered on the back of the
prescription or on another appropriate document. If entered on another
document, such as a medication record, the document must be uniformly
maintained and readily retrievable. The following information must be
retrievable by the prescription number consisting of the name and dosage
form of the controlled substance, the date filled or refilled, the
quantity dispensed, initials of the dispensing pharmacist for each
refill, and the total number of refills for that prescription. If the
pharmacist merely initials and dates the back of the prescription it
shall be deemed that the full face amount of the prescription has been
dispensed. The prescribing practitioner may authorize additional refills
of Schedule III or IV controlled substances on the original prescription
through an oral refill authorization transmitted to the pharmacist
provided the following conditions are met:
(1) The total quantity authorized, including the amount of the
original prescription, does not exceed five refills nor extend beyond
six months from the date of issue of the original prescription.
(2) The pharmacist obtaining the oral authorization records on the
reverse of the original prescription the date, quantity of refill,
number of additional refills authorized, and initials the prescription
showing who received the authorization from the prescribing practitioner
who issued the original prescription.
(3) The quantity of each additional refill authorized is equal to or
less than the quantity authorized for the initial filling of the
original prescription.
[[Page 76]]
(4) The prescribing practitioner must execute a new and separate
prescription for any additional quantities beyond the five refill, six-
month limitation.
(b) As an alternative to the procedures provided by subsection (a),
an automated data processing system may be used for the storage and
retrieval of refill information for prescription orders for controlled
substances in Schedule III and IV, subject to the following conditions:
(1) Any such proposed computerized system must provide on-line
retrieval (via CRT display or hard-copy printout) of original
prescription order information for those prescription orders which are
currently authorized for refilling. This shall include, but is not
limited to, data such as the original prescription number, date of
issuance of the original prescription order by the practitioner, full
name and address of the patient, name, address, and DEA registration
number of the practitioner, and the name, strength, dosage form,
quantity of the controlled substance prescribed (and quantity dispensed
if different from the quantity prescribed), and the total number of
refills authorized by the prescribing practitioner.
(2) Any such proposed computerized system must also provide on-line
retrieval (via CRT display or hard-copy printout) of the current refill
history for Schedule III or IV controlled substance prescription orders
(those authorized for refill during the past six months.) This refill
history shall include, but is not limited to, the name of the controlled
substance, the date of refill, the quantity dispensed, the
identification code, or name or initials of the dispensing pharmacist
for each refill and the total number of refills dispensed to date for
that prescription order.
(3) Documentation of the fact that the refill information entered
into the computer each time a pharmacist refills an original
prescription order for a Schedule III or IV controlled substance is
correct must be provided by the individual pharmacist who makes use of
such a system. If such a system provides a hard-copy printout of each
day's controlled substance prescription order refill data, that printout
shall be verified, dated, and signed by the individual pharmacist who
refilled such a prescription order. The individual pharmacist must
verify that the data indicated is correct and then sign this document in
the same manner as he would sign a check or legal document (e.g., J. H.
Smith, or John H. Smith). This document shall be maintained in a
separate file at that pharmacy for a period of two years from the
dispensing date. This printout of the day's controlled substance
prescription order refill data must be provided to each pharmacy using
such a computerized system within 72 hours of the date on which the
refill was dispensed. It must be verified and signed by each pharmacist
who is involved with such dispensing. In lieu of such a printout, the
pharmacy shall maintain a bound log book, or separate file, in which
each individual pharmacist involved in such dispensing shall sign a
statement (in the manner previously described) each day, attesting to
the fact that the refill information entered into the computer that day
has been reviewed by him and is correct as shown. Such a book or file
must be maintained at the pharmacy employing such a system for a period
of two years after the date of dispensing the appropriately authorized
refill.
(4) Any such computerized system shall have the capability of
producing a printout of any refill data which the user pharmacy is
responsible for maintaining under the Act and its implementing
regulations. For example, this would include a refill-by-refill audit
trail for any specified strength and dosage form of any controlled
substance (by either brand or generic name or both). Such a printout
must include name of the prescribing practitioner, name and address of
the patient, quantity dispensed on each refill, date of dispensing for
each refill, name or identification code of the dispensing pharmacist,
and the number of the original prescription order. In any computerized
system employed by a user pharmacy the central recordkeeping location
must be capable of sending the printout to the pharmacy within 48 hours,
and if a DEA Special
[[Page 77]]
Agent or Diversion Investigator requests a copy of such printout from
the user pharmacy, it must, if requested to do so by the Agent or
Investigator, verify the printout transmittal capability of its system
by documentation (e.g., postmark).
(5) In the event that a pharmacy which employs such a computerized
system experiences system down-time, the pharmacy must have an auxiliary
procedure which will be used for documentation of refills os Schedule
III and IV controlled substance prescription orders. This auxiliary
procedure must insure that refills are authorized by the original
prescription order, that the maximum number of refills has not been
exceeded, and that all of the appropriate data is retained for on-line
data entry as soon as the computer system is available for use again.
(c) When filing refill information for original prescription orders
for Schedule III or IV controlled substances, a pharmacy may use only
one of the two systems described in paragraphs (a) or (b) of this
section.
[36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971. Redesignated at
38 FR 26609, Sept. 24, 1973, and amended at 42 FR 28878, June 6, 1977;
45 FR 44266, July 1, 1980; 52 FR 3605, Feb. 5, 1987; 62 FR 13966, Mar.
24, 1997]
Sec. 1306.23 Partial filling of prescriptions.
The partial filling of a prescription for a controlled substance
listed in Schedule III, IV, or V is permissible, provided that:
(a) Each partial filling is recorded in the same manner as a
refilling,
(b) The total quantity dispensed in all partial fillings does not
exceed the total quantity prescribed, and
(c) No dispensing occurs after 6 months after the date on which the
prescription was issued.
[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24,
1997]
Sec. 1306.24 Labeling of substances and filing of prescriptions.
(a) The pharmacist filling a prescription for a controlled substance
listed in Schedule III, IV, or V shall affix to the package a label
showing the pharmacy name and address, the serial number and date of
initial filling, the name of the patient, the name of the practitioner
issuing the prescription, and directions for use and cautionary
statements, if any, contained in such prescription as required by law.
(b) The requirements of paragraph (a) of this section do not apply
when a controlled substance listed in Schedule III, IV, or V is
prescribed for administration to an ultimate user who is
institutionalized: Provided, That:
(1) Not more than a 34-day supply or 100 dosage units, whichever is
less, of the controlled substance listed in Schedule III, IV, or V is
dispensed at one time;
(2) The controlled substance listed in Schedule III, IV, or V is not
in the possession of the ultimate user prior to administration;
(3) The institution maintains appropriate safeguards and records the
proper administration, control, dispensing, and storage of the
controlled substance listed in Schedule III, IV, or V; and
(4) The system employed by the pharmacist in filling a prescription
is adequate to identify the supplier, the product and the patient, and
to set forth the directions for use and cautionary statements, if any,
contained in the prescription or required by law.
(c) All prescriptions for controlled substances listed in Schedules
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this
chapter.
[62 FR 13965, Mar. 24, 1997]
Sec. 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.
(a) The transfer of original prescription information for a
controlled substance listed in Schedules III, IV or V for the purpose of
refill dispensing is permissible between pharmacies on a one time basis
only. However, pharmacies electronically sharing a real-time, on-line
database may transfer up to the maximum refills permitted by law and the
prescriber's authorization. Transfers are subject to the following
requirements:
[[Page 78]]
(1) The transfer is communicated directly between two licensed
pharmacists and the transferring pharmacist records the following
information:
(i) Write the word ``VOID'' on the face of the invalidated
prescription.
(ii) Record on the reverse of the invalidated prescription the name,
address and DEA registration number of the pharmacy to which it was
transferred and the name of the pharmacist receiving the prescription
information.
(iii) Record the date of the transfer and the name of the pharmacist
transferring the information.
(b) The pharmacist receiving the transferred prescription
information shall reduce to writing the following:
(1) Write the word ``transfer'' on the face of the transferred
prescription.
(2) Provide all information required to be on a prescription
pursuant to 21 CFR 1306.05 and include:
(i) Date of issuance of original prescription;
(ii) Original number of refills authorized on original prescription;
(iii) Date of original dispensing;
(iv) Number of valid refills remaining and date(s) and locations of
previous refill(s);
(v) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription information was
transferred;
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription was originally filled;
(3) The original and transferred prescription(s) must be maintained
for a period of two years from the date of last refill.
(c) Pharmacies electronically accessing the same prescription record
must satisfy all information requirements of a manual mode for
prescription transferral.
(d) The procedure allowing the transfer of prescription information
for refill purposes is permissible only if allowable under existing
state or other applicable law.
[46 FR 48919, Oct. 5, 1981. Redesignated and amended at 62 FR 13966,
Mar. 24, 1997]
Sec. 1306.26 Dispensing without prescription.
A controlled substance listed in Schedules II, III, IV, or V which
is not a prescription drug as determined under the Federal Food, Drug,
and Cosmetic Act, may be dispensed by a pharmacist without a
prescription to a purchaser at retail, provided that:
(a) Such dispensing is made only by a pharmacist (as defined in part
1300 of this chapter), and not by a nonpharmacist employee even if under
the supervision of a pharmacist (although after the pharmacist has
fulfilled his professional and legal responsibilities set forth in this
section, the actual cash, credit transaction, or delivery, may be
completed by a nonpharmacist);
(b) Not more than 240 cc. (8 ounces) of any such controlled
substance containing opium, nor more than 120 cc. (4 ounces) of any
other such controlled substance nor more than 48 dosage units of any
such controlled substance containing opium, nor more than 24 dosage
units of any other such controlled substance may be dispensed at retail
to the same purchaser in any given 48-hour period;
(c) The purchaser is at least 18 years of age;
(d) The pharmacist requires every purchaser of a controlled
substance under this section not known to him to furnish suitable
identification (including proof of age where appropriate);
(e) A bound record book for dispensing of controlled substances
under this section is maintained by the pharmacist, which book shall
contain the name and address of the purchaser, the name and quantity of
controlled substance purchased, the date of each purchase, and the name
or initials of the pharmacist who dispensed the substance to the
purchaser (the book shall be maintained in accordance with the
recordkeeping requirement of Sec. 1304.04 of this chapter); and
[[Page 79]]
(f) A prescription is not required for distribution or dispensing of
the substance pursuant to any other Federal, State or local law.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971.
Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesigated and
amended at 62 FR 13966, Mar. 24, 1997]