STATE | ASPS and OVSPS Coordinate to Protect Plastic Surgeons’ Right to Reconstitute Drugs In-Office
As reported in the May 2015 issue of Advocacy Matters, state pharmacy boards, including Ohio, have started looking to regulate physician in-office compounding and reconstitution. Regulation and oversight of pharmaceutical compounding has been steadily increasing after a 2012 national crisis was sparked by an outbreak of fungal meningitis that was linked to contaminated compounded drugs sourced from the New England Compounding Center.
This spring, an Ohio regulation was scheduled to go into effect that would have required physician practices to register as a drug distributor to compound or reconstitute drugs in-office. Among other changes, the rule would have required that drugs be compounded or reconstituted in an area that was exclusively intended for that purpose, and that the physician's office must meet ISO Class 5 air quality requirements. After receiving comments from ASPS, OVSPS and the medical community in Ohio, the Board determined to delay implementation and revise the rule. The first round of revisions relaxed facility requirements for certain types of compounding and reduced the proposed registration fee. ASPS and OVSPS agreed with the revisions to the rule but remained firm on the point that reconstitution should not be considered drug compounding.
After receiving additional ASPS and OVSPS comments, the Board and executive staff discussed further revisions to the rule, including removing on-label reconstitution from the definition of compounding and preserving an exemption from registration for solo practitioners.
While the Board's willingness to respond to the concerns raised by ASPS, OVSPS, the Ohio State Medical Association and the Ohio physician community is encouraging, ASPS will continue to track and monitor this issue to ensure that its members' concerns are voiced at every stage of the rule-making process.