1. (a) Each program shall maintain accurate records of medications used in replacement narcotic therapy traceable to specific patients, showing dates, quantity, and batch code marks of the medications.

   1. (1) These records shall be maintained by a physician, pharmacist, or health professional authorized to compound, administer or dispense medications used in replacement narcotic therapy.
   2. (2) These records shall be retained for a period of three years.

2. (b) Each program shall describe in its protocol all of the following information for medications used in replacement narcotic therapy:

   1. (1) The records which will be kept to reconcile on a daily basis, the amount of medications received, on hand, and administered or dispensed to patients.
   2. (2) The names of individuals who will actually compound medications used in replacement narcotic therapy and who administer or dispense the patient medication.
   3. (3) The source or supplier of these medications and the form of medications to be purchased for the program.
   4. (4) The name of the person who will purchase these medications and documentation of the federal authorization to do so.
   5. (5) The name and function of anyone, other than a staff member, who handles these medications.
   6. (6) The method used to transfer of these medications within and between facilities.
   7. (7) Security provisions at every location in which these medications will be stored or diluted, and the names of individuals who have access to keys and safe combinations where these medications are stored.

Note: Authority cited: Sections 11755, 11835, 11839.3 and 11839.20, Health and Safety Code. Reference: Sections 11215, 11217, 11839.2, 11839.3 and 11875, Health and Safety Code.

History

1. Change without regulatory effect renumbering and amending parts of former sections 10258 and 10272 to 10255 filed 6-3-91 pursuant to section 100, title 1, California Code of Regulations (Register 91, No. 34).

2. Amendment of article heading, section heading, section and Note filed 3-15-96 as an emergency; operative 3-15-96 (Register 96, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-13-96 or emergency language will be repealed by operation of law on the following day.

3. Amendment of article 3 heading, section heading, section and Note refiled 7-8-96 as an emergency; operative 7-12-96 (Register 96, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-12-96 or emergency language will be repealed by operation of law on the following day.

4. Amendment of article 3 heading, section heading, section and Note refiled 10-23-96 as an emergency; operative 10-29-96 (Register 96, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-26-97 or emergency language will be repealed by operation of law on the following day.

5. Amendment of article 3 heading, section heading, section and Note refiled 2-11-97 as an emergency; operative 2-24-97 (Register 97, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-24-97 or emergency language will be repealed by operation of law on the following day.

6. Certificate of Compliance as to 2-11-97 order transmitted to OAL 3-4-97; disapproved by OAL and order of repeal as to 2-11-97 order filed 4-15-97 (Register 97, No. 16).

7. Amendment of article heading, section heading, section and Note filed 4-15-97 as an emergency; operative 4-15-97 (Register 97, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-13-97 or emergency language will be repealed by operation of law on the following day.

8. Certificate of Compliance as to 4-15-97 order transmitted to OAL 6-2-97 and filed 6-13-97 (Register 97, No. 24).

9. Change without regulatory effect amending Note filed 4-19-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 16).