Cal. Code Regs. tit. 16 § 1717

Current through Register 2024 Notice Reg. No. 49, December 6, 2024

Section 1717 - Pharmacy Practice

(a) No medication shall be dispensed on prescription except in a new container which conforms with standards established in the official compendia. Notwithstanding the above, a pharmacist may dispense and refill a prescription for non-liquid oral products in a clean multiple-drug patient medication package (patient med pak), provided:

(1) a patient med pak is reused only for the same patient;

(2) no more than a one-month supply is dispensed at one time; and

(3) each patient med pak bears an auxiliary label which reads, "store in a cool, dry place."

(b) In addition to the requirements of Business and Professions Code section 4040, the following information shall be maintained for each prescription on file and shall be readily retrievable:

(1) The date dispensed, and the name or initials of the dispensing pharmacist. All prescriptions filled or refilled by an intern pharmacist must also be initialed by the supervising pharmacist before they are dispensed.

(2) The brand name of the drug or device; or if a generic drug or device is dispensed, the distributor's name which appears on the commercial package label; and

(3) If a prescription for a drug or device is refilled, a record of each refill, quantity dispensed, if different, and the initials or name of the dispensing pharmacist.

(4) A new prescription must be created if there is a change in the drug, strength, prescriber or directions for use, unless a complete record of all such changes is otherwise maintained.

(c) Promptly upon receipt of an orally transmitted prescription, the pharmacist shall reduce it to writing, and initial it, and identify it as an orally transmitted prescription. If the prescription is then dispensed by another pharmacist, the dispensing pharmacist shall also initial the prescription to identify him or herself. All orally transmitted prescriptions shall be received and transcribed by a pharmacist prior to compounding, filling, dispensing, or furnishing. Chart orders as defined in section 4019 of the Business and Professions Code are not subject to the provisions of this subsection.

(d) A pharmacist may furnish a drug or device pursuant to a written or oral order from a prescriber licensed in a State other than California in accordance with Business and Professions Code section 4005.

(e) A pharmacist may transfer a prescription for Schedule III, IV or V controlled substances to another pharmacy for refill purposes in accordance with Title 21, Code of Federal Regulations, section 1306.25.

Prescriptions for other dangerous drugs which are not controlled substances may also be transferred by direct communication between pharmacists or by the receiving pharmacist's access to prescriptions or electronic files that have been created or verified by a pharmacist at the transferring pharmacy. The receiving pharmacist shall create a written prescription; identifying it as a transferred prescription; and record the date of transfer and the original prescription number. When a prescription transfer is accomplished via direct access by the receiving pharmacist, the receiving pharmacist shall notify the transferring pharmacy of the transfer. A pharmacist at the transferring pharmacy shall then assure that there is a record of the prescription as having been transferred, and the date of transfer. Each pharmacy shall maintain inventory accountability and pharmacist accountability and dispense in accordance with the provisions of section 1716 of this Division. Information maintained by each pharmacy shall at least include:

(1) Identification of pharmacist(s) transferring information;

(2) Name and identification code or address of the pharmacy from which the prescription was received or to which the prescription was transferred, as appropriate;

(3) Original date and last dispensing date;

(4) Number of refills and date originally authorized;

(5) Number of refills remaining but not dispensed;

(6) Number of refills transferred.

(f) The pharmacy must have written procedures that identify each individual pharmacist responsible for the filling of a prescription and a corresponding entry of information into an automated data processing system, or a manual record system, and the pharmacist shall create in his/her handwriting or through hand-initializing a record of such filling, not later than the beginning of the pharmacy's next operating day. Such record shall be maintained for at least three years.

Cal. Code Regs. Tit. 16, § 1717

1. New subsection (m) filed 5-18-78; effective thirtieth day thereafter (Register 78, No. 20). For prior history, see Register 75, No. 36.
2. New subsection (k) filed 11-8-78; designated effective 1-1-79 (Register 78, No. 45).
3. Repealer of subsections (k) and (m) filed 2-22-80; effective thirtieth day thereafter (Register 80, No. 8).
4. Amendment of subsections (b) and (j) filed 1-28-81; effective thirtieth day thereafter (Register 81, No. 5).
5. Amendment of subsection (f) filed 4-8-81; effective thirtieth day thereafter (Register 81, No. 15).
6. Amendment filed 4-8-82; effective thirtieth day thereafter (Register 82, No. 15).
7. Amendment of subsection (d) and new subsection (f) filed 10-20-82; effective thirtieth day thereafter (Register 82, No. 43).
8. Amendment of subsections (b), (c), (f) and new subsection (g) filed 3-5-86; effective thirtieth day thereafter (Register 86, No. 10).
9. Amendment of subsection (a) filed 5-10-88; operative 6-9-88 (Register 88, No. 20).
10. Amendment of subsection (a) filed 1-20-89; operative 2-19-89 (Register 89, No. 4).
11. Amendment of subsection (c) filed 8-12-92; operative 9-11-92 (Register 92, No. 33).
12. Editorial correction of subsections (b)(1), (f), and (g) (Register 95, No. 16).
13. Change without regulatory effect amending subsections (c)-(d) and NOTE filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
14. Amendment of subsection (e) filed 2-10-2003; operative 3-12-2003 (Register 2003, No. 7).
15. Amendment of section heading and subsections (b)-(b)(1), (c)-(d) and (f) filed 9-7-2005; operative 10-7-2005 (Register 2005, No. 36).
16. Amendment of subsection (b)(1), repealer of subsection (e) and subsection relettering filed 12-27-2006; operative 1-26-2007 (Register 2006, No. 52).
17. Change without regulatory effect amending subsection (e) filed 12-18-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 51).

Note: Authority cited: Sections 4005, 4075 and 4114, Business and Professions Code. Reference: Sections 4005, 4019, 4027, 4050, 4051, 4052, 4075, 4114, 4116, 4117 and 4342, Business and Professions Code.

1. New subsection (m) filed 5-18-78; effective thirtieth day thereafter (Register 78, No. 20). For prior history, see Register 75, No. 36.
2. New subsection (k) filed 11-8-78; designated effective 1-1- 79 (Register 78, No. 45).
3. Repealer of subsections (k) and (m) filed 2-22-80; effective thirtieth day thereafter (Register 80, No. 8).
4. Amendment of subsections (b) and (j) filed 1-28-81; effective thirtieth day thereafter (Register 81, No. 5).
5. Amendment of subsection (f) filed 4-8-81; effective thirtieth day thereafter (Register 81, No. 15).
6. Amendment filed 4-8-82; effective thirtieth day thereafter (Register 82, No. 15).
7. Amendment of subsection (d) and new subsection (f) filed 10- 20-82; effective thirtieth day thereafter (Register 82, No. 43).
8. Amendment of subsections (b), (c), (f) and new subsection (g) filed 3-5-86; effective thirtieth day thereafter (Register 86, No. 10).
9. Amendment of subsection (a) filed 5-10-88; operative 6-9-88 (Register 88, No. 20).
10. Amendment of subsection (a) filed 1-20-89; operative 2-19- 89 (Register 89, No. 4).
11. Amendment of subsection (c) filed 8-12-92; operative 9-11-92 (Register 92, No. 33).
12. Editorial correction of subsections (b)(1), (f), and (g) (Register 95, No. 16).
13. Change without regulatory effect amending subsections (c)-(d) and Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
14. Amendment of subsection (e) filed 2-10-2003; operative 3-12-2003 (Register 2003, No. 7).
15. Amendment of section heading and subsections (b)-(b)(1), (c)-(d) and (f) filed 9-7-2005; operative 10-7-2005 (Register 2005, No. 36).
16. Amendment of subsection (b)(1), repealer of subsection (e) and subsection relettering filed 12-27-2006; operative 1-26-2007 (Register 2006, No. 52).
17. Change without regulatory effect amending subsection (e) filed 12-18-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 51).