Current through Register Vol. 30, No. 38, September 20, 2024
A. A pharmacy
permittee or pharmacist-in-charge shall ensure that a mechanical storage and
counting device for a drug in a solid, oral dosage form that is used by a
pharmacist or a pharmacy intern, graduate intern, pharmacy technician, or
pharmacy technician trainee under the supervision of a pharmacist complies with
the following method to identify the contents of the device:
1. The drug name and strength are affixed to
the front of each cell or cassette of the device;
2. A paper or electronic log is kept for each
cell or cassette that contains:
a. An
identification of the cell or cassette by the drug name and strength or the
number of the cell or cassette;
b.
The drug's manufacturer or National Drug Code (NDC) number;
c. The expiration date and lot number from
the manufacturer's stock bottle that is used to fill the cell or cassette. If
multiple lot numbers of the same drug are added to a cell or cassette, each lot
number and expiration date shall be documented, and the earliest expiration
date shall become the expiration date of the mixed lot of drug in the cell or
cassette;
d. The date the cell or
cassette is filled;
e.
Documentation of the identity of the licensee who placed the drug into the cell
or cassette; and
f. If the licensee
who filled the cell or cassette is not a pharmacist, documentation of the
identity of the pharmacist who supervised the non-pharmacist licensee who
filled the cell or cassette; and
3. The paper or electronic log is available
in the pharmacy for inspection by the Board or its designee for not less than
two years.
B. A pharmacy
permittee or pharmacist-in-charge shall ensure that any drug previously counted
by a mechanical storage and counting device for a drug in a solid, oral dosage
form that has not left the pharmacy is not returned to the drug's cell,
cassette, or stock bottle, unless the drug return method is approved by the
Board or its designee as specified in subsection (G). This subsection does not
prevent a pharmacy permittee or pharmacist-in-charge from using a manual or
mechanical counting device to count and dispense a previously counted drug that
has not left the pharmacy if the previously counted drug is dispensed before
its beyond-use-date.
C. A pharmacy
permittee or pharmacist-in-charge shall ensure the accuracy of any mechanical
storage and counting device for a drug in a solid, oral dosage form that is
used by a pharmacist or a pharmacy intern, graduate intern, pharmacy
technician, or pharmacy technician trainee under the supervision of a
pharmacist by documenting completion of the following:
1. Training in the maintenance, calibration,
and use of the mechanical storage and counting device for each employee who
uses the mechanical storage and counting device;
2. Maintenance and calibration of the
mechanical storage and counting device as recommended by the device's
manufacturer; and
3. Routine
quality assurance and accuracy validation testing for each mechanical storage
and counting device.
D.
A pharmacy permittee or pharmacist-in-charge shall ensure that the
documentation required in subsection (C) is available for inspection by the
Board or its designee.
E. A
pharmacy permittee or pharmacist-in-charge shall:
1. Ensure that policies and procedures for
the performance and use of a mechanical storage and counting device for a drug
in a solid, oral dosage form are prepared, implemented, and complied
with;
2. Review biennially and, if
necessary, revise the policies and procedures required under subsection
(E)(1);
3. Document the review
required under subsection (E)(2);
4. Assemble the policies and procedures as a
written or electronic manual; and
5. Make the policies and procedures available
within the pharmacy for employee reference and inspection by the Board or its
staff.
F. The Board may
prohibit a pharmacy permittee or pharmacist-in-charge from using a mechanical
storage and counting device for a drug in a solid, oral dosage form if the
pharmacy permittee or the pharmacy permittee's employees do not comply with the
requirements of subsections (A), (B), (C), (D), or (E).
G. Returning a drug previously counted by a
mechanical storage and counting device for a drug in a solid, oral dosage form
that has not left the pharmacy to the drug's cell or cassette.
1. Before returning a drug previously counted
by a mechanical storage and counting device that has not left the pharmacy to
the drug's cell or cassette, a pharmacy permittee or pharmacist-in-charge
shall:
a. Apply for approval from the Board or
its designee for the drug return method to be used in returning the
drug;
b. Develop a drug return
method that uses technology, such as bar coding, to prevent drug return
errors;
c. Provide documentation
depicting the drug return method;
d. Demonstrate the drug return method for a
Board Compliance Officer; and
e.
Receive approval from the Board or its designee for the drug return method to
be used in returning the drug.
2. Before approving a request to waive the
drug return prohibition in subsection (B), the Board or its designee shall:
a. Receive a request in writing from the
pharmacy permittee or pharmacist-in-charge;
b. Review the documentation of the drug
return method; and
c. Receive a
satisfactory inspection report from a Board Compliance Officer that the drug
return method uses technology to prevent drug return errors.
