Saturday, June 1, 2013

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

Tennessee Board of Pharmacy Meeting Dates and an Open Invitation for all Pharmacists and the General Public to Attend


Tennessee Board of Pharmacy Meeting Dates
The Board extends an open invitation for all pharmacists as well
as the general public to attend its bimonthly meetings in Nashville.
The following dates are scheduled for 2013:
♦♦ July 9-10, 2013, Iris/Poplar Room – 227 French Landing
♦♦ August 28, 2013, Poplar/Iris Room – 227 French Landing
♦♦ August 29, 2013, Iris Room – 227 French Landing
♦♦ November 13-14, 2013, Iris Room – 227 French Landing
Please check the Board Web site as these dates can be subject
to change. Meetings generally begin at 9 am.

Tennessee Board of Pharmacy Opinions Regarding Repackaging


Board Opinions
At the May 14, 2013 meeting, the Board stated that Tennessee
Board of Pharmacy Rule 1140-04-.10 is interpreted to allow pharmacists
in an institutional setting to return and use medication that is
either in unit-dose packaging or unopened commercially prepackaged
containers and, “. . . in the professional judgment of the pharmacist
in charge or designee, the medications or related materials meet all
federal and state board standards for product integrity. . .” Review
the following link for the rule in its entirety: www.state.tn.us/sos/
rules/1140/1140-04.pdf.
At the same meeting, Tennessee Board of Pharmacy Rule 1140-
03-.08 in regard to a pharmacy repackaging another pharmacy’s
medications was discussed. The Board concluded that it is currently
a violation for one pharmacy to repackage another pharmacy’s
medications. The Board agreed that the process would be positive
for patient safety, but a rule change is needed to legalize this type
of activity.
quoted from Tennessee Board of Pharmacy June 2013 Newsletter

Tennessee New Statute Regarding Office Use


Statute Amended Regarding Compounding
As stated in Public Chapter 266, TCA 63-10-204(4), the definition
of “compounding” includes the following new language:
(D) For use in a licensed prescribing practitioner’s office for
administration to the prescribing practitioner’s patient or
patients when the product is not commercially available
upon receipt of an order from the prescriber;
(E) For use in a health care facility for administration to
a patient or patients receiving treatment or services
provided by the facility when the product is not commercially
available upon receipt of an order from an
authorized licensed medical practitioner of the facility;
(F) For use by emergency medical services for administration
to a patient or patients receiving services from them
under authorized medical control when the product is
not commercially available upon receipt of an order
from a licensed prescriber authorized to provide medical
control; or
(G) For use by a licensed veterinarian for administration
to their non-human patient or patients or for dispensing
to non-human patients in the course of the practice
of veterinary medicine upon receipt of an order from
a veterinarian when the product is not commercially
available.
In TCA 63-10-204(12), the definition of “dispense” now reads
as follows:
. . . “Dispense” means preparing, packaging, compounding
or labeling for delivery and actual delivery of a prescription
drug, nonprescription drug or device in the course of
professional practice to a patient or the patient’s agent, to
include a licensed health care practitioner or a health
care facility providing services or treatment to the patient
or patients, by or pursuant to the lawful order of a
prescriber . . .
TCA 63-10-216 adds this section as follows:
(a) Prior to initial licensure in this state as a compounding
pharmacy, a pharmacy located outside of this state

must have an inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located. Out-of-state pharmacy practice
sites must provide a copy of the most recent inspection
by the regulatory or licensing agency of the state in
which the pharmacy practice site is physically located,
which must have been within the previous twelve (12)
months. Prior to renewal of its license in this state, an
out-of-state pharmacy practice site must provide the
most recent inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located or equivalent regulatory entity,
and which must have been within the previous twelve
(12) months. The board of pharmacy shall have the
right to require additional information before issuing or
renewing a pharmacy license to insure compliance with
applicable laws of this state and any rules and policies
of the board.
(b) Any compounding pharmacy having an active Tennessee
license shall notify the board within fourteen (14)
business days of receipt of any order or decision by a
regulatory agency, other than the Tennessee board of
pharmacy, imposing any disciplinary action, including
any warning, on the pharmacy.
(c) Any pharmacies engaged in sterile compounding must
comply with relevant United States Pharmacopeia (USP)
guidelines as adopted by the board by rule or policy.
(d) Any pharmacies engaging in sterile compounding, except
hospital pharmacies compounding for inpatients of
a hospital, shall report on a quarterly basis to the board
the quantity of sterile compounded products dispensed
in a defined time period in accordance with policies
adopted by the board; provided, however, the executive
director of the board may request this information from
a hospital pharmacy for cause and the hospital pharmacy
shall be required to respond in a timely manner as defined
by the executive director of the board.
The Board plans to discuss rules and policies for additional clarification
to the statute in the near future.
In regard to federal compounding regulations, be advised to
continually monitor United States Code 21 353. The current
regulation may be found at the following Web link: www
.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm155666.htm.

Quoted from Tennessee Board of Pharmacy June 2013 Newsletter