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UPDATE: Recent Press Release Details Proposed U.S. Senate Legislation for Compounding Drugs

July 25, 2013 The Senate Committee on Health, Education, Labor, and Pensions (HELP) recently unveiled its latest version of legislation to tighten regulations on compounding pharmacies.

See the July 25 press release from HELP here.

The Academy and AAOE believe the revisions represent a major win for ophthalmology. The legislation would incorporate changes sought by the Academy, including removal of restrictive patient-prescription requirements for biologics (including bevacizumab), as long as they are ordered from a compounding manufacturer registered with the U.S. Food and Drug Administration. In addition, the bill would create a new oversight structure for the regulation of compounding pharmacies. The updated legislation also includes provisions that would let physicians order some sterile products from traditional compounders for office use.

However, the revised bill does not address the Academy’s remaining concern: prescription requirements for variations of marketed drugs made from bulk substances. The Academy and Senate committee staff have agreed, however, to address this requirement as the bill moves forward. The Academy has signaled its support for the legislation to lawmakers with these changes.

The AAOE Program of the 2013 Annual Meeting in New Orleans includes three sessions on compounding pharmacies:

• Compounding Pharmacies: Legal and Regulatory Issues (Course 182)
  Sunday, Nov. 17, 2 to 3 p.m.
• Compounding Pharmacies: Legal and Regulatory Issues (Course 532)
  Tuesday, Nov. 19, 10:15 to 11:15 a.m.
• Breakfast Roundtable B200 — Compounding Pharmacy Regulations and the Effect on Compounded Medication Supply
  Tuesday, Nov. 19, 7:30 to 8:30 a.m.

OMIC has authored several resources regarding patient safety and legal liabilities associated with compounding pharmacies. See Resources: Compounded Drugs and Off-label Use