CHA News Article

Hospital Sterile Compounding Pharmacies Face New Requirements
BoP releases draft proposed regulations for SB 294

SB 294 (Chapter 565) — signed into law this year following problems at the New England Compounding Center — requires all hospitals with sterile compounding pharmacies to obtain a sterile compounding license by July 1, 2014. Hospitals that have this type of pharmacy but do not yet have the license should submit an application to the California Board of Pharmacy as soon as possible to allow time for processing prior to July 1, 2014. The application is attached.

The Board of Pharmacy has not yet released official proposed regulations for SB 294, but they are expected to be available in mid-November and will undergo a formal 45-day public comment period. The release will contain proposed amendments to Title 16, California Code of Regulations, Sections 1735 et seq. and 1751 et seq. A public hearing on the proposed regulations is expected in mid-January. Attached is a copy of draft proposed regulations that have been “unofficially released” by the Board of Pharmacy. CHA is working through its Medication Safety Committee to develop comments on the regulations.

The new law:

  • Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in the eyes. This is broader than current law that focuses on compounding sterile injectable products only.
  • Requires a sterile compounding license, in addition to the basic hospital pharmacy license, from the Board of Pharmacy for every pharmacy that compounds sterile drug products even if the hospital is accredited. The board will adjust future licensure dates so that the basic hospital pharmacy license and sterile compounding license will expire on the same date.
  • Requires an annual inspection by the board before initial licensure or renewal of the sterile compounding license.
  • Requires out-of-state pharmacies that compound sterile products for use in California to be subject to the sterile compounding pharmacy license and annual inspection by the board.
  • Requires all pharmacies that compound sterile drug products for use in California to comply with regulations in Title 16, California Code of Regulations, Sections 1735 et seq. and 1751 et seq.