California Pharmacy Lawbook Article 11
Title: California Pharmacy Lawbook Article 11
Date Posted: 01/01/11
Tags: REGULATORY UPDATE, NORTH AMERICA, CALIFORNIA
Article 11 Wholesalers and Manufacturers
4163. Unauthorized Furnishing by Manufacturer or Wholesaler
(a) A manufacturer, wholesaler, repackager, or pharmacy may not furnish a dangerous drug or dangerous device to an unauthorized person.
(b) Dangerous drugs or dangerous devices shall be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. When the person acquiring the dangerous drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining confirmation of licensure of those sources from whom it has not previously acquired dangerous drugs or dangerous devices.
(c) Except as otherwise provided in Section 4163.5, commencing on July 1, 2016, a wholesaler or repackager may not sell, trade, or transfer a dangerous drug at wholesale without providing a pedigree.
(d) Except as otherwise provided in Section 4163.5, commencing on July 1, 2016, a wholesaler or repackager may not acquire a dangerous drug without receiving a pedigree.
(e) Except as otherwise provided in Section 4163.5, commencing on July 1, 2017, a pharmacy may not sell, trade, or transfer a dangerous drug at wholesale without providing a pedigree.
(f) Except as otherwise provided in Section 4163.5, commencing on July 1, 2017, a pharmacy may not acquire a dangerous drug without receiving a pedigree.
(g) Except as otherwise provided in Section 4163.5, commencing on July 1, 2017, a pharmacy warehouse may not acquire a dangerous drug without receiving a pedigree. For purposes of this section and Section 4034, a "pharmacy warehouse" means a physical location licensed as a wholesaler for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of those drugs to a group of pharmacies under common ownership and control.
4163.4. Holding Legal Title on Pedigree Requirement Effective Date
(a) All units of dangerous drug in the possession of a wholesaler or pharmacy, for which the manufacturer does not hold legal title on the effective date of the pedigree requirement set forth in Section 4163.5, shall not be subject to the pedigree requirements set forth in Sections 4034 and 4163. However, if any units of those drugs are subsequently returned to the manufacturer, they shall be subject to the pedigree requirements if the manufacturer distributes those units in California.
(b) All units of dangerous drug manufactured in California but distributed outside the state for dispensing outside the state shall not be subject to the pedigree requirements set forth in Sections 4034 and 4163 at either the time of initial distribution or in the event that any of those units are subsequently returned to the manufacturer.
4163.5. Pedigree Requirement Implementation Date
(a) The Legislature hereby finds and declares that:
(1) The electronic pedigree system required by Sections 4034 and 4163 will provide tremendous benefits to the public and to all participants in the distribution chain. Those benefits should be made available as quickly as possible through the full cooperation of prescription drug supply chain participants. To this end, all drug manufacturers and repackagers are strongly encouraged to serialize drug products and initiate electronic pedigrees as soon as possible, and all participants in the supply chain are encouraged to immediately ready themselves to receive and pass electronic pedigrees.
(2) At the same time, it is recognized that the process of implementing serialized electronic pedigree for all prescription drugs in the entire chain of distribution is a complicated technological and logistical undertaking for manufacturers, wholesalers, repackagers, pharmacies, and other supply chain participants. The Legislature seeks to ensure continued availability of prescription drugs in California while participants implement these requirements.
(b) Before January 1, 2015, each manufacturer of a dangerous drug distributed in California shall designate those dangerous drugs representing a minimum of 50 percent of its drugs, generic or single source, distributed in California, for which it is listed as the manufacturer by the federal Food and Drug Administration, which shall be the subject of its initial phase of compliance with the January 1, 2015, deadline of the state’s serialized electronic pedigree requirements set forth in Sections 4034 and 4163. Each manufacturer shall notify the Board of Pharmacy of the drugs so designated and the measure or measures used in designating its drugs to be serialized, and shall include in the notification the technology to be used to meet the serialized electronic pedigree requirements. The notification process for these specific actions may be specified by the board.
(c) Before January 1, 2016, each manufacturer of a dangerous drug distributed in California shall designate the final 50 percent of its drugs, generic or single source, distributed in California for which it is listed as the manufacturer by the federal Food and Drug Administration that are subject to the state’s serialized electronic pedigree requirements set forth in Sections 4034 and 4163, which shall comply with the state’s serialized electronic pedigree requirement by January 1, 2016. Each manufacturer shall notify the Board of Pharmacy of the drugs so designated and the measure or measures used in designating its drugs to be serialized, and shall include in the notification the technology to be used to meet the serialized electronic pedigree requirements. The notification process for these specific actions may be specified by the board.
(d) For purposes of designating drugs to be serialized as required by subdivisions (b) and (c), manufacturers shall select from any of the following measures:
(1) Unit volume.
(2) Product package (SKU) type.
(3) Drug product family.
(e) Drugs not subject to compliance with the pedigree requirements set forth in Sections 4034 and 4163 under this section shall not be subject to the provisions of subdivisions (c), (d), (e), and
(f) of Section 4163.
4164. Reports Required
(a) A wholesaler licensed by the board that distributes controlled substances, dangerous drugs, or dangerous devices within or into this state shall report to the board all sales of dangerous drugs and controlled substances that are subject to abuse, as determined by the board.
(b) Each wholesaler shall develop and maintain a system for tracking individual sales of dangerous drugs at preferential or contract prices to pharmacies that primarily or solely dispense prescription drugs to patients of long-term care facilities. The system shall be capable of identifying purchases of any dangerous drug at preferential or contract prices by customers that vary significantly from prior ordering patterns for the same customer, including by identifying purchases in the preceding 12 calendar months by that customer or similar customers and identifying current purchases that exceed prior purchases by either that customer or similar customers by a factor of 20 percent. Each wholesaler shall have the tracking system required by this subdivision in place no later than January 1, 2006.
(c) Upon written, oral, or electronic request by the board, a wholesaler shall furnish data tracked pursuant to subdivision (b) to the board in written, hardcopy, or electronic form. The board shall specify the dangerous drugs, the customers, or both the dangerous drugs and customers for which data are to be furnished, and the wholesaler shall have 30 calendar days to comply with the request.
(d) As used in this section, "preferential or contract prices" means and refers to purchases by contract of dangerous drugs at prices below the market wholesale price for those drugs.
(e) This section shall become operative on January 1, 2006.