Board of Pharmacy Request for Public Comment: Compounding Statute-Related
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
- 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
- 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
submit all responses to the Maryland Board of Pharmacy no later than July 25,
put “Sterile Compounding Comments Attn: Anna Jeffers” in subject line)
Maryland Board of Pharmacy
4201 Patterson Avenue
Baltimore, MD 21201