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|   | ### American Society of Consultant Pharmacists |
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|   | ### 1321 Duke Street                           |
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|   | ### Alexandria, VA 22314-3563                  |
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|   | Phone: 703-739-1300                            |
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|   | FAX: 703-739-1321                              |
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|   | E-mail: info@ascp.com                          |
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|   | www.ascp.com                                   |
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August 29, 2005

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD  20852

Docket No. 2005D--0174

The American Society of Consultant Pharmacists is pleased to provide
comments regarding the Food and Drug Administration Guidance on
Expiration Dating of Unit-Dose Repackaged Drugs, as released in the
Federal Register under Docket No. 2005D-0174.

The American Society of Consultant Pharmacists (ASCP) is the
international professional association that provides leadership,
education, advocacy, and resources to advance the practice of senior
care pharmacy. Consultant pharmacists specializing in senior care
pharmacy practice are essential participants in the health care system,
recognized and valued for the practice of pharmaceutical care for the
senior population and people with chronic illness. In their role as
medication therapy experts, consultant pharmacists take responsibility
for their patients' medication-related needs; ensure that their
patients' medications are the most appropriate, the most effective, the
safest possible, and are used correctly; and identify, resolve, and
prevent medication-related problems that may interfere with the goals of
therapy. ASCP's 6,500+ members manage and improve drug therapy and
improve the quality of life of geriatric patients and other individuals
residing in a variety of environments, including nursing facilities,
subacute care and assisted living facilities, psychiatric hospitals,
hospice programs, and home and community-based care.

The dispensing and administration processes in the long-term care
nursing facilities, assisted living facilities, group homes, and
correctional facilities that ASCP members service are very similar to
those in hospitals, as mentioned in the proposed Compliance Policy
Guide. Due to the need for convenient medication packaging that allows
for efficient, accurate, and reconcilable distribution and
administration, unit dose packaging has been the primary type of
packaging system used by long-term care pharmacies for over 30 years.

We commend the Food and Drug Administration for providing guidance on
this long-standing issue. While we realize that pharmacies repackaging
medications will not be required to have stability studies supporting
the expiration dates they use, we find a few of the proposed guidelines,
as currently written, potentially problematic.

Bulk containers of tablets and capsules packaged by the manufacturer are
often only available in bottles of 100 or more, while most medication
orders are dispensed in quantities of 7, 15, or multiples of 30. None of
these dispensed quantities are conducive to repackaging bulk bottle
quantities in their entirety because it is inevitable that there will be
some tablets or capsules left over. According to the proposed Compliance
Policy Guide, this would be in violation of the requirement to repackage
the entire contents of a bulk container in one operation. Even though
many pharmacies "pre-package" some medications in advance of orders
being received, not all medications are dispensed frequently enough to
justify pre-packaging at all or in the quantities necessary to fulfill
the proposed guidelines.

For example, methocarbamol is a muscle relaxant that is used on
occasion, but not frequently in the long-term care setting. For
cost-effective reasons, a pharmacy may choose to pre-package the top 100
medications they dispense based on dispensed quantities or number of
prescription orders. Methocarbamol does not likely fall on this list;
therefore, it is not pre-packaged on a routine basis. When an order for
methocarbamol is received by the pharmacy, they pull their bulk
container of #100 tablets from the shelf, repackage an appropriate
quantity for that particular order (e.g., #30), and return the bulk
container to the shelf for future use. To abide by the proposed
guidelines, which state the entire contents of the bulk container should
be repackaged in one operation, the pharmacy would be left with #70
tablets -- a quantity that would likely never be dispensed from a
pharmacy. To remedy this situation, the pharmacy would have to repackage
three full bottles of #100 tablets each for dispensing of the original
order in addition to pre-packaging potential useable quantities of #30
tablets per card or box for future use. This is not only time-intensive,
but could be a monetary loss for the pharmacy if it does not use those
additional repackaged cards/boxes or if future orders for that
medication are not prescribed in quantities equal to the quantities they
repackaged. There is a lack of evidence describing why a container must
be repackaged in its entirety versus other options, such as noting the
opened date on a bulk container and maintaining an expiration date
within one year from that date for repackaged medications originating
from that bulk container. For these reasons, we recommend editing
statement #3 on page 3 of the Compliance Guide to read:

"The original bulk container of drug product has not been opened
previously and the entire contents are repackaged in one operation, when
possible."

The second issue we would like to discuss is the temperature
recommendations in statement #4 on page 3 of the Compliance Guide. Many
repackaging processes appropriately use momentary heat to seal unit dose
packages. Therefore, for clarification purposes, we recommend editing
statement #4 to read:

"Where no temperature is specified in the labeling of the original drug
product, a controlled room temperature (as defined in the General
Notices and Requirements section of the USP) should be maintained during
repackaging and storage of both solid and liquid oral dosage form drug
products, except for momentary introduction of heat required for the
sealing process."

We appreciate the opportunity to provide feedback on the proposed
guidance document regarding expiration dating of unit-dose repackaged
medications. If we can answer any questions or provide information about
our members' use of specialized packaging, we would be glad to do so.

Sincerely,

Carla Saxton, RPh, CGP

Assistant Director, Policy and Advocacy

American Society of Consultant Pharmacists

1321 Duke St.

Alexandria, VA 22314

\(703\) 739-1316 ext. 129

E-mail: csaxton@ascp.com