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DHMH : BOP public comment compounding

Maryland Board of Pharmacy Request for Public Comment: Compounding Statute-Related Questions

In the summer and fall of 2012, contaminated injectable steroids produced by the Massachusetts-based New England Compounding Center caused a multistate outbreak of fungal infections, including fatal fungal meningitis infections. The contaminated injectable steroids were shipped to seven facilities in Maryland. At least 26 people were infected by the contaminated steroids administered in Maryland; three of those people have died. In response to this situation, a new statute was enacted which provides the Maryland Board of Pharmacy more authority to oversee sterile compounding. The Board is soliciting public input on several related questions.

First, the statute allows the board to set additional requirements for a separate license for sterile compounding.

  • What special requirements for sterile compounding should the Board consider?

Second, the new statute prohibits the sale of sterile medications not produced by FDA licensed manufacturers or made pursuant to a sterile compounding license; however, the law permits the Board of Pharmacy to waive - in special, specified situations - these requirements and allow products manufactured in bulk in a facility that is not FDA licensed and where products are not traditionally compounded. Such a waiver may be issued only in exigent circumstances for drugs for which there is a clinical need.

  • What are such exigent circumstances that might necessitate a waiver?
  • What are examples of specific sterile products and clinical situations that might meet criteria for such a waiver?
  • What process can the Board use to keep a current list of products for which there is a need for a waiver?
  • In addition to provision of reports of inspections, a statement of compliance with USP 797, and review and report of any adverse regulatory action, what else should be required of people or facilities producing and distributing “waived” sterile products?
  • How can the Board know when the need for a “waived” sterile product no longer exists?
  • Should there be an emergency waiver process, and if so, when would that be needed and how might that work?

Please submit all responses to the Maryland Board of Pharmacy no later than July 25, 2013. 


(please put “Sterile Compounding Comments Attn: Anna Jeffers” in subject line)

  Mail:      Maryland Board of Pharmacy
                4201 Patterson Avenue
                Baltimore, MD 21201
                Attn:  Anna Jeffers