Based on the Final Order of Adoption published by the California Board of Pharmacy. View official source document.
| Topic | Old framework (pre-2025) | New framework (2025) |
|---|---|---|
| Regulatory structure | Requirements spread across earlier Articles; less consolidated treatment of HDs and radiopharmaceuticals. | Repeals prior sections and creates dedicated Articles for Nonsterile, Sterile, Hazardous, and Radiopharmaceutical compounding. |
| Definitions & alignment | Relied on USP but with fewer California-specific supplemental definitions visible in one place. | Explicitly supplements USP 795/797/825/800 with state definitions (e.g., “designated person,” “integrity,” “quality,” “essentially a copy”). |
| Nonsterile labeling | Core elements required; fewer explicit California-specific items. | Adds route of administration and compounding/dispensing facility names; plus special handling/warnings and facility contact if sent outside the system. |
| Nonsterile BUDs | General USP-based BUD approach. | BUD with date-only expires 11:59 p.m.; must not exceed stability, container-closure compatibility, or the shortest component expiry; USP 51 compliance for antimicrobial effectiveness testing when used. |
| Nonsterile SOPs & QA | QA programs required; timelines less explicit. | SOPs must follow USP 1163; initiate quality review within 72 hours; notify the Board within 96 hours for potential quality problems with CNSPs. |
| Nonsterile records | Recordkeeping required. | Three-year retention; audit trail of changes; maintain prior versions with who/when changed; specific CR elements (manufacturer/lot/expiry; unique ID; quantities; personnel). |
| Flavoring agents | Allowed, guidance varied. | Codifies pharmacist ability to add flavor to oral liquids without prescriber consult; mandates SOPs (label note, BUD support, complaint reporting within 96 hours). |
| Sterile release testing | USP-based expectations. | Pharmacist responsible for integrity/quality until BUD; alternate sterility methods must meet USP 1223; injectable CSPs from nonsterile components require endotoxin testing per USP 85 before furnishing. |
| Sterile labeling | Core label standards. | Must include route; infusion solution; administration instructions incl. infusion rate/range or total duration; facility names; inpatient exceptions specified. |
| Sterile BUDs | General USP approach. | Date-only BUDs expire 11:59 p.m.; may not exceed stability, container-closure compatibility, or shortest component expiry; testing reviewed prior to furnishing and retained in CR. |
| Single-dose containers | Handled per USP. | If punctured outside ISO 5 → discard immediately; inside ISO 5 → discard within 12 hours. |
| Sterile QA & documentation | Recordkeeping required. | Three-year retention; audit trail for revisions; PIC to initiate review of CSP quality complaints/adverse experiences within 72 hours; packaging must protect product & personnel. |
| Allergenic extracts | General sterile rules applied. | Dedicated area/PEC required; surface cleaned immediately post-prep; patient-specific prescriptions only. |
| Hazardous drugs (USP 800) | HD handling referenced broadly. | Creates Article 4.7: applies to HD compounding and handling of antineoplastics; transport & dispensing specifics (e.g., labeled outer containers, provide/offer ASTM D-6978 gloves; attach/prime tubing & use CSTD when appropriate; one HD prep at a time in a C-PEC; sterile mats handling). |
| Radiopharmaceuticals (USP 825) | No dedicated California Article mirroring USP 825. | Creates Article 4.8 adopting USP 825 baseline; adds QA/complaint timelines (PIC review within 72 hours; Board notice within 96 hours); labeling to include special storage/handling and USP Table 7 elements where applicable; SOPs for ISO failures/downtime. |
Effective June 17, 2025. Please consult the full document for operational details:
California Board of Pharmacy Order of Adoption
© PharKeep.com