20 CSR 2220-2.410 - Class B Hospital Pharmacy Compounding for Drug Shortages
PURPOSE: This rule establishes requirements for Class B hospital pharmacies compounding medication in the event of a drug shortage.
(1) Class B
hospital pharmacies may compound and provide medications that are in shortage
to patients without a patient-specific prescription, provided-
(A) The pharmacy has confirmed and documented
the product is not available despite due diligence;
(B) The medication is compounded for
administration to patients in a hospital clinic or facility or in another
hospital that is under common control, management, or ownership of the same
hospital or hospital system, as defined by section
338.165, RSMo;
(C) The preparation compounded is the same
dosage form and strength that is in shortage;
(D) The quantity distributed at one time does
not exceed the amount needed to meet the anticipated healthcare practitioner
need for seven (7) days based on the hospital's or hospital clinic's/facility's
usage;
(E) The pharmacy must stop
compounding and distribution once the product is available;
(F) The pharmacy must label the preparation
container with-
1. Pharmacy name, address, and
telephone number;
2. Date of
distribution;
3. Preparation name,
strength, dosage form, and quantity;
4. Name of each active or therapeutic
ingredient included in the preparation;
5. Preparation lot/batch number;
6. Preparation beyond-use date; and
7. Statement: "Pharmacy Compounded
Preparation";
(G) The
pharmacy maintains a record of the distribution that is readily available on
request of the board or the board's authorized designee and can be retrieved by
specific hospital or hospital clinic or facility, if requested;
(H) In lieu of recording an identifying
prescription number or a readily retrievable unique identifier, the hospital or
hospital clinic or facility name must be recorded on the compounding
log;
(I) The pharmacy must comply
with all applicable provisions of
20 CSR
2220-2.400. A Class H license and compliance with
20 CSR
2220-2.200 is required for any sterile preparation;
and
(J) The pharmacy complies with
all applicable controlled substance laws and regulations.
(2) Unless otherwise provided by law or court
of competent jurisdiction, the provisions of this rule are only applicable to
pharmacy services under the jurisdiction of the board and are not applicable to
hospital pharmacy services under the jurisdiction of the Missouri Department of
Health and Senior Services pursuant to Chapter 197, RSMo.
Notes
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