California Business and Professions Code ARTICLE 7.7 - Outsourcing Facilities

• Section 4129.
  (a) A facility licensed as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing...
• Section 4129.1.
  (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed...
• Section 4129.2.
  (a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of this...
• Section 4129.3.
  (a) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident outsourcing facilities. The report shall...
• Section 4129.4.
  (a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that an outsourcing facility compounding sterile...
• Section 4129.5.
  Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to...
• Section 4129.8.
  The board, at its discretion, may issue a temporary license to an outsourcing facility upon the conditions and for any periods of time as the...
• Section 4129.9.
  (a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile drug or nonsterile drug compounded by the...

Last modified: October 22, 2018