North Dakota Board of Pharmacy Explains Repackaging Rules

Administrative Guidelines for Repackaging of
Prescriptions
Repackaging by provider pharmacies or consultant pharmacists
for patients in long-term care facilities who receive medications
in packaging that does not conform to the medication distribution
system, chosen by the facility, is appropriate under these guidelines:
1. Medication is delivered to the facility or the repackaging
pharmacy so storage and handling under United States Pharmacopeia
guidelines is assured.
2. The dispensing pharmacy provides the manufacturer’s original
lot number and expiration date.
a. If no lot number is provided, an alternate number will be
assigned by the repackaging pharmacy. If there is a recall
of medication dispensed without the original lot number,
the recall will affect all of the named drug.
b. The repackaging pharmacy will assign an expiration date
not more than six months from the date of dispensing by
the original pharmacy, or the original expiration date,
whichever is shortest.
3. A log must be kept by the repackaging pharmacy containing
the following information:
a. Patient’s name
b. Name, address, and phone number of original dispensing
pharmacy
c. The prescription number of the original dispensing pharmacy
d. Date of dispensing by the original dispensing pharmacy
e. Expiration date assigned by the original dispensing pharmacy,
if available
f. The manufacturer’s lot number or the number assigned by
the original dispensing pharmacy, if available
g. The name of the product and identification of the manufacturer
h. The quantity of product received and repackaged
i. The prescription number assigned by the repackaging
pharmacy
j. Lot number assigned by the repackaging pharmacy or
indication that the manufacturer’s original lot number
was used
4. The repackaging pharmacy is responsible for storage of the
unused portion of the prescription until redistribution to the
facility.
5. Charges for repackaging can be borne by the original dispensing
pharmacy or the facility, but cannot be included by the
consultant or repackager as part of another service. These
charges must be billed separately to avoid the appearance
of kickbacks. Medicaid does not allow repackaging charges
directly to the department by the pharmacy. The patient may
not be charged separately, as the distribution system is a
requirement of the nursing facility and should be included in
their rate. The cost is allowable by Medicaid on the facility
cost report.
6. The repackaging pharmacist is the final decision maker as
to whether the repackaging will be done, and the product
utilized by the patient.

quoted from the North Dakota Board of Pharmacy June 2013 Newsletter