Friday, November 30, 2012

Washington State Department of Health Pharmacy Compounding Standards


Pharmacy Compounding Standards

Standards for Pharmacist/Pharmacies Compounding Drug Products

  • Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription for an individual based on past routine prescribing patterns.
  • The patient and prescriber must authorize the use of a compounded product if substituted for a commercially available product. The prescriber’s authorization is in addition to signing the substitution permitted side of the written prescription, or advising the substitution when a verbal prescription is issued. The prescriber must document the authorization on the prescription or in the patient’s medication record.
  • Drugs/substances used for compounding must meet official compendia requirements.
  • The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
  • Pharmacists/Pharmacies shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.
  • Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.
  • Records and Reports related to Compounding Procedures or other records required by Chapter 246-878 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-869-100).
  • All records must be readily available at the pharmacy/establishment for authorized inspection during the retention period. As part of the inspection, the records are subject to photocopying or other means of reproduction.
  • Compounding records may be kept either in its original format or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. 
Source found here

CA Board of Pharmacy to hold special board meeting RE: legislative proposal for compounding pharmacies on December 13, 2012


Special Board of Pharmacy Meeting Announced
November 21, 2012

The Board announces the convening of a special, one-day Board Meeting on December 13, 2012 in Sacramento. Two main elements for this meeting will be a regulation hearing on the adoption of two regulations for e-pedigree implementation, and refinement of a legislative proposal for compounding pharmacies. The agenda for this meeting will be released in early December (before December 3, 2012).

Gov. may seek changes in Mass. pharmacy board


November 28, 2012, 11:24 am

BOSTON (AP) — Gov. Deval Patrick says the state board that oversees pharmacies is too heavily dominated by people who are pharmacists themselves and he might seek a change in the panel's makeup.
The state Board of Pharmacy has come under scrutiny in the aftermath of a national fungal meningitis outbreak that has claimed 36 lives and sickened hundreds of others. The outbreak has been linked to a steroid produced by Framingham-based New England Compounding Center, which is regulated by the board.
Patrick said Wednesday he has become concerned that 10-member board is largely made up of pharmacists and he'd like to see a "different blend of talent."
He told the "Ask the Governor" program on WTKK-FM that he expected to file legislation when state lawmakers return to Beacon Hill in January.



Source found here