Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule:
(1)
"Pharmacy delivery agent" means an employee of the pharmacy,
United States postal service, or common or contract carrier who delivers
dangerous drugs that have been dispensed.
(2)
"Psychiatric
outpatient facility" means a facility where psychiatric evaluation and
treatment is provided on an outpatient basis.
(B)
An outpatient
pharmacy may return dangerous drugs to stock shelves that have been dispensed,
but have never left the pharmacy (i.e. never picked up by a patient or
caregiver) or the control of a pharmacy delivery agent (i.e. never delivered to
a patient or caregiver), if the pharmacy complies with all of the
following:
(1)
The pharmacy has the capability to place the expiration
date, as required by this rule, on the prescription label.
(2)
The expiration
date on the label shall not exceed the expiration date on the manufacturer's
container or one year from the date the drug was originally dispensed and
placed in the prescription vial, whichever date is earlier. If multiple
manufacturer containers are used, the expiration date shall not exceed the
expiration date on the manufacturer's container that will expire first or one
year from the date the drug was originally dispensed and placed in the
prescription vial, whichever date is earlier. If the prescription container is
the manufacturer's original sealed packaging, the expiration date is the
expiration date listed on the packaging.
(3)
The dangerous
drug products returned to stock shelves shall be maintained in the container in
which they were filled and shall maintain their original prescription label
containing the original expiration date assigned. The label on the container
shall not be removed, altered, or replaced with another label or have any other
label added, except as follows:
(a)
Adding to or modifying the existing label, if the drug
name, dose, and original expiration date are maintained.
(b)
Adding a new
label over the existing label on the container. In this instance, the drug
shall be verified by a pharmacist or an electronic verification system
following the application of the new label. The new label shall include the
expiration date assigned on the original label.
(c)
A prescription
label may be removed if the prescription container is the manufacturer's
original sealed packaging and the removal of the label does not remove or
otherwise cause to make unreadable the expiration date and lot number on the
manufacturer's packaging.
(4)
The contents of a
prescription vial or container shall not be returned to the manufacturer's
stock bottle.
(5)
When dispensing a dangerous drug that was previously
returned to stock to another patient, a new container shall be used or, in the
case of unit dose or unit of use products, all previous patient information
shall be removed.
(6)
Drugs returned to stock shelves shall be stored in
accordance with rule
4729:5-5-02 of the
Administrative Code. The pharmacy shall develop and implement a policy to
ensure that drugs are maintained by pharmacy delivery agents within
temperatures as stipulated by the USP/NF and/or the manufacturer's or
distributor's labeling.
(7)
In the case of recalls, any drugs returned to stock
shelves containing the drug affected by the recall shall be removed from the
shelves immediately, unless the lot number can be determined.
(8)
A dangerous drug
that leaves the prescription department of the pharmacy in the custody of a
pharmacy delivery agent may only be returned to stock shelves if the drug meets
either of the following prior to initially leaving the prescription
department:
(a)
Each dangerous drug prescription is dispensed in a tamper
evident container or package prior to leaving the pharmacy; or
(b)
The dangerous
drug prescription is dispensed in the manufacturer's original tamper evident
packaging.
(9)
A dangerous drug that is dispensed and shows any signs
of tampering or adulteration shall not be returned to stock
shelves.
(C)
A dangerous drug that exceeds its assigned expiration
date, as described in paragraph (B) of this rule, shall be removed from the
area for the storage of drugs used for dispensing and administration in
accordance with rule
4729:5-3-06 of the
Administrative Code.
(D)
Non-controlled drugs dispensed by a government entity
and delivered for outpatients to a psychiatric outpatient facility or to any
service provider licensed as a terminal distributor of dangerous drugs may be
returned to stock if all the following apply:
(1)
The drugs are
packaged in unopened, single-dose or tamper-evident containers;
and
(2)
The drugs have not been in the possession of the
ultimate user.
(E)
This rule does not apply to drugs dispensed for
inpatients pursuant to agency 4729 of the Administrative Code. Drugs dispensed
for inpatients may be returned to stock in accordance with the applicable
provisions of agency 4729 of the Administrative Code.
(F)
A pharmacy may
transfer dangerous drugs that are returned to stock shelves that meet the
requirements of this rule to another pharmacy if the transfer is conducted in
accordance with paragraph (E) of rule
4729:5-3-09 of the
Administrative Code.
Replaces: 4729-5-14
