Section 1735.3 - Recordkeeping for Compounded Drug Preparations(a) For each compounded drug preparation, pharmacy records shall include: (1) The master formula document.(2) A compounding log consisting of a single document containing all of the following:(A) Name and Strength of the compounded drug preparation.(B) The date the drug preparation was compounded.(C) The identity of any pharmacy personnel engaged in compounding the drug preparation.(D) The identity of the pharmacist reviewing the final drug preparation.(E) The quantity of each ingredient used in compounding the drug preparation.(F) The manufacturer, expiration date and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. If the manufacturer does not supply an expiration date for any component, the records shall include the date of receipt of the component in the pharmacy, and the limitations of section 1735.2, subdivision (l) shall apply. (i) Exempt from the requirements in this paragraph (1735.3(a)(2)(F)) are sterile preparations compounded in a single lot for administration within seventy-two (72) hours to a patient in a health care facility licensed under section 1250 of the Health and Safety Code and stored in accordance with standards for "Redispensed CSPs" found in Chapter 797 of the United States Pharmacopeia -- National Formulary (USP37-NF32) Through 2nd Supplement (37th Revision, Effective December 1, 2014), hereby incorporated by reference.(G) A pharmacy-assigned unique reference or lot number for the compounded drug preparation.(H) The beyond use date or beyond use date and time of the final compounded drug preparation, expressed in the compounding document in a standard date and time format.(I) The final quantity or amount of drug preparation compounded for dispensing.(J) Documentation of quality reviews and required post-compounding process and procedures.(b) Pharmacies shall maintain records of the proper acquisition, storage, and destruction of chemicals, bulk drug substances, drug products, and components used in compounding.(c) Active ingredients shall be obtained from a supplier registered with the Food and Drug Administration (FDA). All other chemicals, bulk drug substances, and drug products used to compound drug preparations shall be obtained, whenever possible, from FDA- registered suppliers. The pharmacy shall acquire and retain certificates of purity or analysis, either written in English or translated into English, for chemicals, bulk drug substances, and drug products used in compounding. Certificates of purity or analysis are not required for drug products that are approved by the FDA. Any certificates of purity or analysis acquired by the pharmacy shall be matched to the corresponding chemical, bulk drug substance, or drug products received.(d) Pharmacies shall maintain and retain all records required by this article in the pharmacy in a readily retrievable form for at least three years from the date the record was last in effect. If only recorded and stored electronically, on magnetic media, or in any other computerized form, the records shall be maintained as specified by Business and Professions Code section 4070 subsection (c).Cal. Code Regs. Tit. 16, § 1735.3
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of subsection (a)(6), repealer of former subsection (a)(7) and subsection renumbering filed 2-6-2013; operative 4-1-2013 (Register 2013, No. 6).
3. Amendment of section heading and section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38). Note: Authority cited: Sections 4005, 4127 and 4169, Business and Professions Code. Reference: Sections 4005, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code.
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of subsection (a)(6), repealer of former subsection (a)(7) and subsection renumbering filed 2-6-2013; operative 4-1-2013 (Register 2013, No. 6).
3. Amendment of section heading and section filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).