[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1306.13]

[Page 82-83]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1306_PRESCRIPTIONS--Table of Contents
 
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 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

[[Page 83]]

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]