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Section 109320 Of Article 2. Prohibitions And Enforcement From California Health And Safety Code >> Division 104. >> Part 4. >> Chapter 4. >> Article 2.
109320
. (a) The board shall issue an order withdrawing approval of
an application concerning any drug, medicine, compound, or device if,
after due notice to the applicant and opportunity for a hearing, the
board finds any of the following:
(1) That clinical or other experience, tests, or other scientific data show that the drug, medicine, compound, or device is unsafe for use under the conditions of use upon the basis that the application was approved;
(2) That new evidence of clinical experience, not contained in the application or not available to the board until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the board when the application was approved, shows that the drug, medicine, compound, or device is not shown to be safe for use under conditions of use upon the basis that the application was approved; or
(3) On the basis of new information with respect to the drug, medicine, compound, or device, evaluated together with the evidence available to the board when the application was approved, that there is a lack of substantial evidence that the drug, medicine, compound, or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or advertising thereof; or
(4) That the application contains any untrue statement of a material fact.
(b) If the board finds that there is an imminent hazard to the public health, it may suspend the approval of the application immediately.
(c) The board may also, after due notice and opportunity for hearing, withdraw the approval of an application with respect to any drug, medicine, compound, or device under this section if the board finds any of the following:
(1) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(2) That on the basis of new information before the board, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, maintenance, processing, and packing of the drug, medicine, compound, or device are inadequate to assure and preserve its identity, strength, quality, and purity and with respect to a device are inadequate to preserve its safety or effectiveness and were not made adequate within a reasonable time after receipt of written notice from the board specifying the matter complained of.
(3) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling of the drug, medicine, compound, or device, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the board specifying the matter complained of.
(d) Any order under this section shall state the findings upon which it is based.
(1) That clinical or other experience, tests, or other scientific data show that the drug, medicine, compound, or device is unsafe for use under the conditions of use upon the basis that the application was approved;
(2) That new evidence of clinical experience, not contained in the application or not available to the board until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the board when the application was approved, shows that the drug, medicine, compound, or device is not shown to be safe for use under conditions of use upon the basis that the application was approved; or
(3) On the basis of new information with respect to the drug, medicine, compound, or device, evaluated together with the evidence available to the board when the application was approved, that there is a lack of substantial evidence that the drug, medicine, compound, or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or advertising thereof; or
(4) That the application contains any untrue statement of a material fact.
(b) If the board finds that there is an imminent hazard to the public health, it may suspend the approval of the application immediately.
(c) The board may also, after due notice and opportunity for hearing, withdraw the approval of an application with respect to any drug, medicine, compound, or device under this section if the board finds any of the following:
(1) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(2) That on the basis of new information before the board, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, maintenance, processing, and packing of the drug, medicine, compound, or device are inadequate to assure and preserve its identity, strength, quality, and purity and with respect to a device are inadequate to preserve its safety or effectiveness and were not made adequate within a reasonable time after receipt of written notice from the board specifying the matter complained of.
(3) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling of the drug, medicine, compound, or device, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the board specifying the matter complained of.
(d) Any order under this section shall state the findings upon which it is based.
