Enforcement/Compounding Committee Meeting
January 10, 2014
Federal Drug Safety and Quality Act - HR 3204, a federal compounding/track-and-trace bill passed late last year, preempts California’s E-pedigree law. Board counsel mentioned it could be advantageous for the Board to consider legislation to repeal California’s E-pedigree law. The Board might also consider this legislation because the Board has interest in reinstating certain provisions contained within the E-pedigree law. The Board made three motions: to publish the notification contained in the meeting materials which state that all of California’s E-pedigree laws are rendered inoperative by enactment of HR 3204; to sponsor legislation to repeal California’s E-pedigree law; and to stop the adoption of and withdraw pending regulations to implement California’s e-pedigree provisions. HR 3204 also prevents California from licensing Third-Party Logistics Providers or Reverse Third-Party Logistics Providers as wholesalers. The Board made a motion to move forward with staff language included in the meeting materials to remedy this discrepancy.
January 10, 2014
The Board’s Enforcement/Compounding Committee met on January 10, 2014 in Sacramento and discussed the following issue:
AB 1136 – The California Legislature passed AB 1136 in the fall of 2013 which would require a Rx label to note that the drug could impair an individual’s ability to operate a vehicle “or vessel.” The Board considered if, given the passage of AB 1136, the list of medication classes in regulation section 1744 are still current. Board staff will bring language for the next Enforcement Committee meeting for discussion.
Discussion Around Tramodol – The DEA is considering classifying Tramodol as a schedule IV and has published a notice to that effect. The Board supports the change.
Sharp’s Request for a Waiver of 16 California Code of Regulations
Section 1713(d) to Permit Expanded Use of Automated Prescription Dispensing
Machines – Sharp (and Asteres) had previously requested to add an automated dispensing machine in an unlicensed facility but doing so was deemed impossible due to legislative requirements. Sharp is now looking to host the machine in a licensed facility (employee entrance hallway). Per Board materials, they are also requesting a waiver of the provisions of Section 1713 for purposes of conducting a pilot study with UCSD to determine if use of the technology improves medication adherence in the targeted audience. The Board has the authority to waive regulatory requirements for pilot studies per 1706.5. The Board made a motion to approve the pilot but a consultation must take place for any new medication prior to the close of business hours. CSHP Board Chairman Steve Gray voiced support for Sharp’s request.
MedAvail Presentation on their Vending Machine – MedAvail gave a presentation on their vending machine, MedCenter. MedAvail will potentially seeking pilot project approval from the Board at a future meeting.
Scripp’s Request for Waiver for Barcoding Requirement of Central Packaging Pharmacy – Counsel said that the Board could a) give a 4118 waiver, b) exercise enforcement discretion, or c) a legislative language solution. The Board made a motion to allow for a 4118 waiver. The Board encouraged CSHP and CHA (the sponsors of AB 377 which created the Central Packaging Pharmacy Licensure Category in California statute) to run legislation to clarify the definition of “retrievable”.
SB 294 Update - The Board reiterated that pharmacies who are only accredited through Joint Commission or another accrediting body MUST be licensed by the Board as a compounding pharmacy by July 1, 2014. The Board urges hospitals and pharmacies to apply EARLY. The final application is not yet available but will be made available; however, the current application online can be used. The Board will be inspecting applicants before July 1, 2014. These inspections will be against current regulations. These will be unannounced inspections. For hospitals, inspectors will be inspecting any location where compounding takes place. This could require hospitals to have multiple compounding licenses even though only one hospital license is needed.
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