b. Emergent In-Office Use.
It was pointed out that the ability to obtain non-patient specific
sterile compounds for emergent in-office use is critical for the
immediate treatment of urgent conditions that require timely
administration of medications to prevent negative health care
outcomes. It was recommended that the definition of “emergent”
include any diagnosis where treatment with a sterile compounded
medication within 72 business hours is clinically necessary to
prevent adverse health outcomes.
The Board notes that within a 72 hour window a patient specific
prescription could be made available to obtain the medications
needed and would not be an emergent reason for a waiver. In
addition, compounding under urgent conditions becomes a patient
safety risk.
Additionally, the Board will place in the proposed regulations a
provision that does not allow a waiver based on criteria based on
financial or business concerns. The Board believes this supports the
intent of the legislation that allows a waiver for which there is a
clinical need and there are emergent circumstances that, as
determined by the Board, otherwise prevent health care providers
from obtaining, in the size and strength needed, the specified sterile
compounded preparations or sterile drug products for which there is
a clinical need.
c. Non-Compounding Manufacturers
It was suggested that entities that could not obtain an FDA permit be
automatically waived from the requirements of a wholesale
distributor permit.
Additionally, it was noted that federal legislation is pending that
precludes an entity that is licensed as a pharmacy from receiving a
compounding manufacturer permit from the FDA in order to
differentiate between federal and state oversight. Those entities that
have dual business purposes, patient specific and sterile drug
products would not be able to register with the FDA and would not
be eligible to ship non-patient specific sterile drug products into MD
without a waiver.
The Board notes that this is the intent of HB 986 – to provide a
mechanism to provide a waiver for those entities that do not qualify
for a sterile compounding permit or are not able to obtain an FDA
permit and to know exactly which entities are dispensing or
distributing sterile drug products to Maryland citizens.
A suggestion for dual business entities that perform patient specific
compounding and compound sterile drug products would be for
those entities to establish separate entities for each purpose.
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