[Title 21 CFR 1306]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT]
[Part 1306 - PRESCRIPTIONS]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  9
  1996-04-01
  1996-04-01
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  1306
  PART 1306
  
    FOOD AND DRUGS
    DRUG ENFORCEMENT
  


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.
1306.15  Filing of prescriptions.

          Controlled Substances Listed in Schedules III and IV

1306.21  Requirement of prescription.
1306.22  Refilling of prescriptions.
1306.23  Partial filling of prescriptions.
1306.24  Labeling of substances.
1306.25  Filing prescriptions.
1306.26  Transfer between pharmacies of presription information for 
          Schedules III, IV, and V controlled substances for refill 
          purposes.

               Controlled Substances Listed in Schedule V

1306.31  Requirement of prescription.
1306.32  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.

    As used in this part, the following terms shall have the meanings 
specified:
    (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 
21 U.S.C. 801).
    (b) The term individual practitioner means a physician, dentist, 
veterinarian, or other individual licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which he 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacist, a pharmacy, or 
an institutional practitioner.
    (c) The term institutional practitioner means a hospital or other 
person (other than an individual) licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which it 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacy.
    (d) The term pharmacist means any pharmacist licensed by a State to 
dispense controlled substances, and shall include any other person 
(e.g., a pharmacist intern) authorized by a State to dispense controlled 
substances under the supervision of a pharmacist licensed by such State.
    (e) A Long Term Care Facility (LTCF) means a nursing home, 
retirement care, mental care or other facility or institution which 
provides extended health care to resident patients.
    (f) The term prescription means an order for medication which is 
dispensed to or for an ultimate user but does not include an order for 
medication which is dispensed for immediate administration to the 
ultimate used. (e.g., an order to dispense a drug to a bed patient for 
immediate administration in a hospital is not a prescription.)
    (g) The terms register and registered refer to registration required 
and permitted by section 303 of the Act (21 U.S.C. 823).
    (h) The term home infusion pharmacy means a pharmacy which compounds 
solutions for direct administration to a patient in a private residence, 
Long Term Care Facility or hospice setting by means of parenteral, 
intravenous,

[[Page 70]]

intramuscular, subcutaneous or intraspinal infusion.
    (i) Any term not defined in this section shall have the definition 
set forth in section 102 of the Act (21 U.S.C. 802) or Sec. 1301.02 of 
this chapter.

(21 U.S.C. 801, et seq.)

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 54330, July 15, 1980; 59 FR 26111, May 19, 1994]



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. 1301.24(c) and 1301.25 of this chapter.
    (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]



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. 1301.24(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. 1301.24(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,

[[Page 71]]

as well as the signature of the physician.
    (c) An official exempted from registration under Sec. 1301.25 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]



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 in 
Schedule II, which is a prescription drug as determined by 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 agency to a 
pharmacy via facsimile equipment, provided 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) or (f) of this section. The original prescription shall be 
maintained in accordance with Sec. 1304.04(h).
    (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

[[Page 72]]

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 72 hours 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 72-hour period. Upon receipt, the dispensing pharmacist shall 
attach this prescription to the oral emergency prercription 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 home infusion 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).
    (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).

[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]



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

[[Page 73]]

pharmacist shall so notify the prescribing individual practitioner. No 
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 contract 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. Prior to 
any subsequent partial filling the pharmacist is to determine that the 
additional partial filling is necessary. 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.

(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]



Sec. 1306.14   Labeling of substances.

    (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

[[Page 74]]

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.

[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]



Sec. 1306.15   Filing of prescriptions.

    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 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, 
and amended at 51 FR 5320, Feb. 13, 1986]

          Controlled Substances Listed in Schedules III and IV



Sec. 1306.21   Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule III or IV, 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 or IV 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 Schedules 
III or IV only pursuant to 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 Sec. 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.

[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. 
Redesignated at 38 FR 26609, Sept. 24, 1973; 59 FR 26112, May 19, 1994]



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

[[Page 75]]

practioner 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.
    (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 
retrival 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 duing 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

[[Page 76]]

user pharmacy the central recordkeeping location must be capable of 
sending the printout to the pharmacy within 48 hours, and if a DEA 
Special Agent or Compliance 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]



Sec. 1306.23   Partial filling of prescriptions.

    The partial filling of a prescription for a controlled substance 
listed in Schedule III or IV 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]



Sec. 1306.24   Labeling of substances.

    (a) The pharmacist filling a prescription for a controlled substance 
listed in Schedule III or IV 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 or IV 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 or IV is 
dispensed at one time;
    (2) The controlled substance listed in Schedule III or IV 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 or IV; 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.

[36 FR 7799, Apr. 24, 1971. Redesignated at 36 FR 18733, Sept. 21, 1971, 
and amended at 37 FR 15921, Aug. 8, 1972]



Sec. 1306.25   Filing prescriptions.

    All prescriptions for controlled substances listed in Schedules III 
and IV shall be kept in accordance with Sec. 1304.04(h) of this chapter.

[36 FR 7799, Apr. 24, 1971. Redesignated at 36 FR 18733, Sept. 21, 1971, 
and amended at 51 FR 5320, Feb. 13, 1986]



Sec. 1306.26  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

[[Page 77]]

one time basis subject to the following requirements:
    (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 of last refill;
    (v) Pharmacy's name, address, DEA registration number and original 
prescription number from which the prescription information was 
transferred;
    (vi) Name of transferor pharmacist.
    (3) Both the original and transferred prescription 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]

               Controlled Substances Listed in Schedule V



Sec. 1306.31   Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule V pursuant to a prescription as required for controlled 
substances listed in Schedules III and IV in Sec. 1306.21. A 
prescription for a controlled substance listed in Schedule V may be 
refilled only as expressly authorized by the prescribing individual 
practitioner on the prescription; if no such authorization is given, the 
prescription may not be refilled. A pharmacist dispensing such substance 
pursuant to a prescription shall label the substance in accordance with 
Sec. 1306.24 and file the prescription in accordance with Sec. 1306.25.
    (b) An individual practitioner may administer or dispense directly a 
controlled substance listed in Schedule V 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 V 
only pursuant to a written prescription signed by an individual 
practitioner, or pursuant to a facsimile of a written prescription 
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 
Sec. 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.

[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 51 FR 5320, 
Feb. 13, 1986; 59 FR 26112, May 19, 1994; 59 FR 30832, June 15, 1994]

[[Page 78]]



Sec. 1306.32   Dispensing without prescription.

    A controlled substance listed in Schedule V, and a controlled 
substance listed in Schedule II, III, or IV 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 
Sec. 1306.02(d)), 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
    (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]