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House releases over-the-counter monograph reform draft bill ahead of hearing

OTC Monograph Draft Bill Includes Packaging Requirements, Sunscreen Act Amendments

September 11, 2017
House lawmakers released Monday (Sept. 11) a bipartisan discussion draft of their proposed over-the-counter monograph user fee program (OMUFA), coming two days ahead of an Energy & Commerce health subcommittee hearing on ways to reform the OTC monograph process. The House draft, unlike the Senate draft that Inside Health Policy reported on in May , lays out packaging requirements for drugs subject to certain administrative orders and includes an expanded section on amendments to the Sunscreen Innovation Act (SIA). Last...

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