PURPOSE: This rule establishes requirements
for drug repackaging.
PUBLISHER'S NOTE: The secretary of state has
determined that the publication of the entire text of the material which is
incorporated by reference as a portion of this rule would be unduly cumbersome
or expensive. Therefore, the material which is so incorporated is on file with
the agency who filed this rule, and with the Office of the Secretary of State.
Any interested person may view this material at either agency's headquarters or
the same will be made available at the Office of the Secretary of State at a
cost not to exceed actual cost of copy reproduction. The entire text of the
rule is printed here. This note refers only to the incorporated by reference
material.
(1) A pharmacist or
pharmacy may prepackage drugs for other than immediate dispensing purposes
provided that the following conditions are met:
(A) Only products which will be directly
provided to the patient may be prepackaged;
(B) Containers utilized for prepackaging
shall meet, as a minimum requirement, that of Class B container standards as
referenced by the United States Pharmacopoeia (USP), which has been
incorporated herein by reference. Where applicable, light sensitive containers
shall be used;
(C) The maximum
expiration date allowed for prepacked drugs shall be the manufacturer's
expiration date or twelve (12) months, whichever is less; and
(D) Any prepacked drug must have a label
affixed to it which contains, at a minimum, the name and strength of the drug,
the name of the manufacturer or distributor, an expiration date as defined in
subsection (1)(C) and lot number. Pharmacies that store drugs within an
automated counting device may, in place of the required label, maintain records
for lot numbers and expiration dates that are required on the label as long as
it is fully traceable and is readily retrievable during an
inspection.
(2) The term
prepacked as used in this rule is defined as any drug which has been removed
from the original manufacturer's container and is placed in a dispensing
container for other than immediate dispensing to a
patient.
