Section 425 - Application for a Therapeutic Use Exemption (Tue)(a) A TUE shall not be granted for any form of Testosterone Replacement Therapy except as required by law.(b) An athlete may apply to the commission for a TUE by submitting an Application for Determination of Therapeutic Use Exemption (form number PA014, revised 07/15, Incorporated by Reference). Such application must be complete and received by the Commission at least thirty (30) days in advance of the event in which the athlete will compete.(c) Each of the following shall accompany the Application for Determination of Therapeutic Use Exemption: (1) Medical information, which shall include: (A) Diagnosis and etiology based upon the treating physician's evaluation.(B) An evaluation by a Board-certified physician in the appropriate medical field.(C) Patient medical history, which must be consistent with the standard of practice in the appropriate medical field relevant to the exemption requested.(D) A physical exam, which must be consistent with the standard of practice in the appropriate medical field relevant to the exemption requested.(E) A testing/laboratory evaluation, which must be consistent with the standard of practice in the appropriate medical field relevant to the exemption requested.(F) Pre-Fight -- Lab data for the Prohibited Substance. If a value is found to be out of the normal range, the athlete's medical provider should take action to correct the level by repeating the lab and/or adjusting medication appropriately, which should be documented in the records submitted to the Commission.(G) Day of Fight -- Lab data for the therapeutic agent in question. Agent specific levels shall be drawn on the day of fight.(H) Name of the Prohibited Substance or Prohibited Method.(I) Dosage taken or to be taken.(J) Method of administration.(K) Duration of treatment.(2) A copy of the medical records in which the applicant's medical condition is well documented, and which must reflect that the condition existed prior to any test for a TUE application was performed.(3) Declaration under penalty of perjury of a board certified physician in the appropriate field of medicine, attesting that he/she has read and understood this Therapeutic Use Exemption Regulation, examined the athlete, and the athlete qualifies for an exemption.(d) A TUE application shall not be considered complete until the commission concludes there is sufficient medical information to determine the athlete is currently physically fit to compete safely. (1) A TUE application may be considered incomplete if the commission cannot reasonably verify the current licensure status of the athlete's treating physician or the medical information submitted with the TUE application. If a TUE application is incomplete, the commission may require the athlete to provide medical information, including but not limited to, an examination pursuant to Rule 280, and lab reports from a certified laboratory as designated by the commission.(2) All costs of providing information to provide a complete TUE application shall be the athlete's responsibility and information provided pursuant to this Rule shall not be considered a special medical evaluation within the meaning of Business and Professions Code section 18710.(e) If the athlete intends to compete further in any event or competition that may subject the athlete to drug testing by the commission, the athlete must apply for a separate TUE for any prohibited substance in advance of such event or competition in accordance with the provisions of this Article.(f) Retroactive Approvals in Emergency or Acute Medical Situations: The time period specified in this Article for submitting a TUE application shall not apply to TUE applications for retroactive approval. Retroactive TUE applications will only be considered in cases where emergency treatment or treatment of an acute medical condition was medically necessary.(g) An TUE application that is approved pursuant to this Article shall be valid for one approved competition.Cal. Code Regs. Tit. 4, § 425
1. New section filed 9-15-2016; operative 1-1-2017 (Register 2016, No. 38). Note: Authority cited: Section 18611, Business and Professions Code. Reference: Sections 18640, 18642, 18648, 18649, 18661 and 18711, Business and Professions Code.
1. New section filed 9-15-2016; operative 1/1/2017 (Register 2016, No. 38).