Home Table of Contents

§ 1751.1. Sterile Compounding Recordkeeping Requirements.

16 CA ADC § 1751.1Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 16. Professional and Vocational Regulations
Division 17. California State Board of Pharmacy (Refs & Annos)
Article 7. Sterile Compounding
16 CCR § 1751.1
§ 1751.1. Sterile Compounding Recordkeeping Requirements.
Currentness
(a) In addition to the records required by section 1735.3, any pharmacy engaged in any compounding of sterile drug preparations shall maintain the following records, which must be readily retrievable, within the pharmacy:
(1) Documents evidencing training and competency evaluations of employees in sterile drug preparation policies and procedures.
(2) Results of hand hygiene and garbing assessments with integrated gloved fingertip testing.
(3) Results of assessments of personnel for aseptic techniques including results of media-fill tests and gloved fingertip testing performed in association with media-fill tests.
(4) Results of viable air and surface sampling.
(5) Biannual video of smoke studies in all ISO Class 5 certified spaces.
(6) Documents indicating daily documentation of room, refrigerator, and freezer temperatures appropriate for sterile compounded drug preparations consistent with the temperatures listed in section 1735.1 for:
(A) Controlled room temperature.
(B) Controlled cold temperature.
(C) Controlled freezer temperature.
(7) Certification(s) of the sterile compounding environment(s).
(8) Documents indicating daily documentation of air pressure differentials or air velocity measurements between all adjoining ISO rooms or areas, including those associated with compounding aseptic (containment) isolators, and air pressure differentials or air velocity measurements between all rooms or spaces with an immediate entry or opening to ISO rooms or areas.
(9) Other facility quality control records specific to the pharmacy's policies and procedures (e.g., cleaning logs for facilities and equipment).
(10) Logs or other documentation of inspections for expired or recalled chemicals, bulk drug substances, drug products, or other ingredients.
(11) Preparation records including the master formula document, the preparation compounding log, and records of end-product evaluation testing and results.
(b) Pharmacies compounding sterile drug preparations for future use pursuant to section 1735.2 shall, in addition to those records required by section 1735.3, make and keep records indicating the name, lot number, and amount of any drug preparation compounded for future use, the date on which any preparation was provided to a prescriber, and the name, address, license type and number of the prescriber.
(c) 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 created. 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).

Credits

Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4029, 4036, 4037, 4051, 4052, and 4127, Business and Professions Code.
History
1. New section filed 10-6-86; effective thirtieth day thereafter (Register 86, No. 42).
2. Change without regulatory effect amending Note filed 9-11-2002 pursuant to section 100, title 1, California Code of Regulations (Register 2002, No. 37).
3. Repealer of section 1751.1 and renumbering of section 1751.3 to section 1751.1, including amendment of section heading, section and Note, filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
4. Amendment of section heading and section filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).
5. Amendment of subsection (a)(5) and Note filed 1-30-2019; operative 1-30-2019 pursuant to Government Code section 11343.4(b)(3) (Register 2019, No. 5).
This database is current through 4/19/24 Register 2024, No. 16.
Cal. Admin. Code tit. 16, § 1751.1, 16 CA ADC § 1751.1
End of Document