American Society of Cataract and Refractive Surgery Concerned About DQSA's effect on drugs such as Avastin

Compounded Drugs

Access to Compounded Drugs ASCRS supports efforts to ensure the safety and sterility of compounded drugs. The recently enacted H.R. 3204, the Drug Quality and Security Act (P.L. 113-54), seeks to improve safety of compounded drugs.  H.R. 3204 represents a compromise between the Health, Education, Labor, and Pensions (HELP) and House Energy and Commerce Committees.  The bill creates a new category of pharmacies—outsourcing facilities—that would voluntarily submit to stricter FDA oversight. The H.R. 3204 incorporated some of the provisions advocated by ASCRS and the medical community throughout the year as legislation was being developed, such as eliminating a requirement for national patient-specific prescriptions for all compounded drugs, including those made from bulk substances, and the opportunity to review FDA recommendations before certain drugs are placed on a “do not compound” list. Providers would have access to compounded drugs for office use through the outsourcing facilities. The bill’s sponsors intend for traditional compounding for patient-specific prescriptions and limited office use to continue to operate under current law, however, the medical community continues to have concerns with the affect this new law could have. Most importantly for ophthalmology, the bill does not include repackaging in the compounding definition and leaves it to the FDA to determine how repackaged drugs, such as Avastin, would be regulated. ASCRS and the ophthalmic community remain concerned that this will limit access to repackaged drugs.  ASCRS will monitor this issue as it is implemented.   Resources: H.R. 3204, the Drug Quality and Security Act H.R. 3089, the Compounding Clarity Act Section-by-Section Summary of S. 959 Draft House Bill on Drug Compounding S. 959, the Pharmaceutical Compounding Quality and Accountability Act ASCRS letter to Senate Health, Education, Labor, and Pensions Committee requesting exemption for office use quoted from here