Statutes, codes, and regulations
California Code Of Regulations
Title 15 - Crime Prevention and CorrectionsDivision 3 - Adult Institutions, Programs and ParoleChapter 2 - Rules and Regulations of Health Care ServicesSubchapter 3 - Health Care Operations
Article 8 - Pharmacy
Section 3999.382 - Investigational Medications

Cal. Code Regs. tit. 15 § 3999.382

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Current through Register 2024 Notice Reg. No. 24, June 14, 2024
Section 3999.382 - Investigational Medications
(a) The Department shall allow the use of investigational medications if:
(1) The investigational medication is medically necessary and is only available through an investigational treatment protocol.
(2) The investigational protocol is used (active drug, not placebo).
(3) Drug information about the investigational medication is acquired by the physician and distributed to the pharmacy and nursing staff.
(4) The nonformulary medication process is followed.
(5) The investigational medication is administered as Directly Observed Therapy medication.
(6) The investigational medication is included in the patient's medication profile.
(7) The physician obtains informed consent from the patient prior to prescribing the investigational medication.

Cal. Code Regs. Tit. 15, § 3999.382

1. New section filed 7-1-2019 as an emergency; operative 7-1-2019 (Register 2019, No. 27). Pursuant to Penal Code section 5058.3, a Certificate of Compliance must be transmitted to OAL by 12-9-2019 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 12-5-2019 as an emergency; operative 12-10-2019 (Register 2019, No. 49). Pursuant to Penal Code section 5058.3, a Certificate of Compliance must be transmitted to OAL by 3-9-2020 or emergency language will be repealed by operation of law on the following day.
3. New section refiled 3-9-2020 as an emergency; operative 3-10-2020 (Register 2020, No. 11). A Certificate of Compliance must be transmitted to OAL by 6-8-2020 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 3-9-2020 order transmitted to OAL 6-8-2020 and filed 7-20-2020 (Register 2020, No. 30).

Note: Authority cited: Section 5058, Penal Code. Reference: Sections 3502.5 and 5054, Penal Code; and Plata v. Newsom (No. C01-1351 JST), U.S. District Court, Northern District of California.

1. New section filed 7-1-2019 as an emergency; operative 7/1/2019 (Register 2019, No. 27). Pursuant to Penal Code section 5058.3, a Certificate of Compliance must be transmitted to OAL by 12-9-2019 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 12-5-2019 as an emergency; operative 12/10/2019 (Register 2019, No. 49). Pursuant to Penal Code section 5058.3, a Certificate of Compliance must be transmitted to OAL by 3-9-2020 or emergency language will be repealed by operation of law on the following day.
3. New section refiled 3-9-2020 as an emergency; operative 3/10/2020 (Register 2020, No. 11). A Certificate of Compliance must be transmitted to OAL by 6-8-2020 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 3-9-2020 order transmitted to OAL 6-8-2020 and filed 7/20/2020 (Register 2020, No. 30).