Maryland Board of Pharmacy Recently Discussed Emergent In-Office Use

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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