Cal. Code Regs. Tit. 16, § 1735 - Compounding in Licensed Pharmacies

(a) "Compounding" means any of the following activities occurring in a licensed pharmacy, by or under the supervision of a licensed pharmacist, pursuant to a prescription:

(1) Altering the dosage form or delivery system of a drug

(2) Altering the strength of a drug

(3) Combining components or active ingredients

(4) Preparing a compounded drug preparation from chemicals or bulk drug substances

(b) "Compounding" does not include reconstitution of a drug pursuant to a manufacturer's direction(s), nor does it include the sole act of tablet splitting or crushing, capsule opening, or the addition of flavoring agent(s) to enhance palatability.

(c) The parameters and requirements stated by Article 4.5 (Section 1735 et seq.) apply to all compounding practices. Additional parameters and requirements applicable solely to sterile compounding are stated by Article 7 (Section 1751 et seq.).

Notes

Cal. Code Regs. Tit. 16, § 1735

1. New article 4.5 (sections 1735-1735.8) and section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of subsections (a)(4) and (b), repealer of subsection (c), subsection relettering and amendment of newly designated subsection (c) filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).

Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code.

1. New article 4.5 (sections 1735-1735.8) and section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of subsections (a)(4) and (b), repealer of subsection (c), subsection relettering and amendment of newly designated subsection (c) filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).