1. (a) “Approved labeling” means the Food and Drug Administration's (FDA) approved labeling in accordance with sections 201.56 and 201.57 of title 21, Code of Federal Regulations that includes FDA approved information (as applicable) for the diluent, the resultant strength, the container closure system, and storage time.
2. (b) “Designated person(s)” means one or more individuals assigned by the pharmacist-in-charge (PIC) to be responsible and accountable for the performance and operation of the facility and personnel as related to the preparation of the compounded nonsterile preparations (CNSP) for the purposes of this article). Nothing in this definition allows for a designated person to exceed the scope of their issued license. When the designated person is not a pharmacist, the PIC must review all practices related to the operations of the facility that require the professional judgment of a pharmacist. Nothing in this definition prohibits the PIC from also serving as the designated person.
3. (c) “Diluent” means a liquid with no pharmacological activity used in reconstitution, such as Purified Water or Sterile Water.
4. (d) “Essentially a copy” of a commercially available drug product means a preparation that includes the same active pharmaceutical ingredient(s) (API(s)) as the commercially available drug product, except that it does not include any preparation in which there has been a change made for an identified individual patient that produces for that patient a clinically significant difference, as verified and documented by the pharmacist, between that compounded preparation and the comparable commercially available drug product.
5. (e) “Integrity” means retention of strength until the beyond use date provided on the label when the preparation is stored and handled according to the label directions.
6. (f) “Quality” means the absence of harmful levels of contaminants, including filth, putrid, or decomposed substances, or the absence of active ingredients other than those listed on the label, or the absence of inactive ingredients other than those listed on the master formulation record as specified in USP Chapter 795.
7. (g) “Repackaging” means the act of removing a product or preparation from its original primary container and placing it into another primary container, usually of smaller size without further manipulation of the product or preparation, when the act is not done pursuant to a prescription.
8. (h) “Strength” means the amount of active ingredient per unit of a compounded drug preparation.

In addition to the definitions contained in United States Pharmacopeia (USP) General Chapter 795, titled Pharmaceutical Compounding -- Nonsterile Preparations (USP Chapter 795), the following definitions apply to this article and supplement the definitions provided in USP Chapter 795 for compounded nonsterile preparations (CNSPs).

Note: Authority cited: Sections 4005 and 4126.8 of Business and Professions Code. Reference: Sections 4005, 4076, 4081, 4126.8, 4169, 4301 and 4332, Business and Professions Code.

History

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).

3. Amendment of article heading and repealer and new section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).