Many veterinary practices use compounded
medications in place of generic or legend brands in
their day-to-day operations. Compounded medications
refer to FDA-approved medications (generic or legend)
that have been altered to meet the needs of a particular
patient. FDA rules state that compounded medications
must be formulated directly from approved generic or
legend products, when such products are available. The
use of bulk products or raw active ingredients during the
compounding process is prohibited. Furthermore, if an
FDA-approved formulation of equal strength and form
exists, compounding of the product is prohibited.
Compounding pharmacies must carry current
licenses with the Board of Pharmacy in each state
where medications are compounded. In addition, the
compounding pharmacy must be registered in each state
to which it ships products. Therefore, if a practice uses
a compounding pharmacy in New Jersey, that pharmacy
must be registered with the California Board of Pharmacy.
To check the status of a pharmacy license with the
California Board of Pharmacy, visit: http://www.pharmacy.
ca.gov/online/verify_lic.shtml and select either “sterile
compounding” or “non-resident sterile compounding.”
While these rules are primarily applicable to the
compounding pharmacies, they do impact the veterinarian
because veterinarians are liable for medications used
or dispensed in their practice. Therefore, veterinary
practices that use compounded medications should
consult with the compounding pharmacy to determine
how the medications are being manufactured and
whether or not proper licensing exists.
In addition, should a practice regularly use
compounded products in their hospital stock, the
following California laws must be considered:
Compounding Defined
According to the California Code of Regulations, Title 16,
Section 1735(a): compounding means:
•
Altering the dosage form or delivery system of a drug
•
Altering the strength of a drug
•
Combining components or active ingredients
•
Preparing a drug product from chemicals or bulk
drug substances
Examples of compounding would include: making
a paste or oral suspension from crushed or melted
pills, or combining two injectable
medications in one vial or
syringe.
Compounding Exceptions
According to the same code listed above, compounding
does not include:
•
Reconstituting a drug pursuant to manufacturer’s
directions
•
Tablet splitting
•
Adding flavoring agents to enhance palatability
The 72-Hour Compounding Rule
It is unlawful for a practice to dispense compounded
medications to clients out of stock. The law states that
practitioners must provide a written or oral prescription
for a compounded product, to be filled by the client for
the animal patient. Therefore, while a veterinary practice
may use compounded medications for administration
in house, it must not send clients home with medication
from this stock.
One exception to this rule exists: the 72-hour
compounding rule. California Code of Regulations Title
16, Section 1735.2 (b) states that a practice may prepare
and store a limited quantity of a compounded product in
advance of a patient-specific prescription where such a
quantity is necessary to ensure continuity of care. The
law goes on to define a reasonable quantity as not more
than a 72-hour (i.e., three-day) supply, which is distributed
to a client upon patient discharge.
The 72-hour rule, which is enforced by the California
Veterinary Medical Board, is based on the scenario of
the Friday afternoon appointment. If a veterinarian sees
a patient on Friday at 4:30 and determines the need for
a compounded medication to suit that patient’s specific
needs, it may be impossible to obtain that medication until
Monday. Therefore, the law allows for a 72-hour supply
to be sent home with the client from the practice’s stock.
Veterinary practices may use compounded medications
in house, provided that the source that they are obtaining
the medications from is following FDA compounding
rules. If a practice dispenses a compounded medication,
the practice must observe the 72-hour limit on dispensed
medication and in turn provide clients with a prescription
to be filled at a compounding pharmacy once the three-
day supply is finished.
Charlotte Lacroix, DVM, JD