Section 1751.7 - Sterile Compounding Quality Assurance and Process Validation(a) Any pharmacy engaged in compounding sterile drug preparations shall maintain, as part of its written policies and procedures, a written quality assurance plan including, in addition to the elements required by section 1735.8, a documented, ongoing quality assurance program that monitors personnel performance, equipment, and facilities. The end product shall be examined on a periodic sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications. The quality assurance program shall include at least the following: (1) Procedures for cleaning and sanitization of the sterile preparation area.(2) Actions to be taken in the event of a drug recall.(3) Documentation justifying the chosen beyond use dates for compounded sterile drug preparations.(b)(1) The pharmacy and each individual involved in the compounding of sterile drug preparations must successfully demonstrate competency on aseptic technique and aseptic area practices before being allowed to prepare sterile drug preparations. The validation process shall be carried out in the same manner as normal production, except that an appropriate microbiological growth medium is used in place of the actual product used during sterile preparation. The validation process shall be representative of the types of manipulations, products and batch sizes the individual is expected to prepare and include a media-fill test. The validation process shall be as complicated as the most complex manipulations performed by staff and contain the same amount or greater amount of volume transferred during the compounding process. The same personnel, procedures, equipment, and materials must be used in the testing. Media used must have demonstrated the ability to support and promote growth. Completed medium samples must be incubated in a manner consistent with the manufacturer's recommendations. If microbial growth is detected, then each individual's sterile preparation process must be evaluated, corrective action taken and documented, and the validation process repeated.(2) Each individual's competency must be revalidated at least every twelve months for sterile to sterile compounding and at least every six months for individuals compounding sterile preparations from non-sterile ingredients.(3) The pharmacy's validation process on aseptic technique and aseptic area practices must be revalidated whenever: (A) the quality assurance program yields an unacceptable result,(B) there is any change in the compounding process, the Primary Engineering Control (PEC), or the compounding environment. For purposes of this subsection, a change includes, but is not limited to, when the PEC is moved, repaired or replaced, when the facility is modified in a manner that affects airflow or traffic patterns, or when improper aseptic techniques are observed.(4) The pharmacy must document the validation and revalidation process.(c) All sterile compounding personnel must successfully complete an initial competency evaluation. In addition, immediately following the initial hand hygiene and garbing procedure, each individual who may be required to do so in practice must successfully complete a gloved fingertip (all fingers on both hands) sampling procedure (zero colony forming units for both hands) at least three times before initially being allowed to compound sterile drug preparations.(d) Re-evaluation of garbing and gloving competency shall occur at least every 12 months for personnel compounding products made from sterile ingredients and at least every six months for personnel compounding products from non-sterile ingredients.(e)(1) Batch-produced sterile drug preparations compounded from one or more non-sterile ingredients, except as provided in paragraph (2), shall be subject to documented end product testing for sterility and pyrogens and shall be quarantined until the end product testing confirms sterility and acceptable levels of pyrogens. Sterility testing shall be USP chapter 71 compliant and pyrogens testing shall confirm acceptable levels of pyrogens per USP chapter 85 limits, before dispensing. This requirement of end product testing confirming sterility and acceptable levels of pyrogens prior to dispensing shall apply regardless of any sterility or pyrogen testing that may have been conducted on any ingredient or combination of ingredients that were previously non-sterile. Exempt from pyrogen testing are topical ophthalmic and inhalation preparations.(2) The following non-sterile-to-sterile batch drug preparations do not require end product testing for sterility and pyrogens:(A) Preparations for self-administered ophthalmic drops in a quantity sufficient for administration to a single patient for 30 days or less pursuant to a prescription.(B) Preparations for self-administered inhalation in a quantity sufficient for administration to a single patient for 5 days or less pursuant to a prescription.Cal. Code Regs. Tit. 16, § 1751.7
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. Amendment of section heading and section filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Amendment of section heading, section and NOTE filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading and section 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 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. Amendment of section heading and section filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
4. Amendment of section heading, section and Note filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5. Amendment of section heading and section filed 9-13-2016; operative 1/1/2017 (Register 2016, No. 38).