[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2007]
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

[[Page 83]]

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]