Section Ph 404.05 - Sterile Quality Requirements(a) Each compounder shall maintain documentation that confirms staff training and competency related to proper garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures prior to compounding of any actual sterile product preparation.(b) Each compounder shall maintain documentation that confirms that the compounder tests aseptic techniques of all staff that compounds sterile products by preparing media fill units per USP standards.(c) Each compounder shall maintain documentation that confirms all staff that compounds sterile products are pre-qualified using media fills before compounding of actual drug preparations.(d) When a positive media fill occurs, compounder shall perform a comprehensive investigation to identify root cause, and document the finding.(e) When a positive media fill occurs, compounder shall institute corrective and preventive action, and document the corrective action.(f) Each compounder shall verify that all personnel who compound sterile products are complying with gowning, gloving, and glove-tip processes consistent with USP standards by meeting the following requirements: (1) Three glove fingertip tests shall be performed initially then annually for low and medium risk compounding;(2) Three glove fingertip tests shall be performed initially then every 6 months for high risk compounding; and(3) Media fill tests shall be performed every 6 months for high risk compounding.(g) Each compounder shall perform routine surface microbiological and fungal environmental monitoring to minimize contamination at least every 6 months, or in accordance with facilities policies.(h) Each compounder shall perform comprehensive investigations of out-of-limit findings, as recommended by USP standards to determine root cause, followed by corrective and preventative actions at least weekly. Each compounder shall maintain all documentation of its findings.(i) Each compounder shall perform, at least semi-annually, viable particle testing in primary engineering controls, such as laminar flow workbench, biological safety cabinet and room air according to USP standards.(j) Each compounder shall ensure that all compounded sterile products that require refrigeration are stored in appropriate refrigeration at all times.(k) When a compounder assigns a BUD for a sterile product that exceeds BUD limits established in USP standards, a compounder shall have laboratory testing results that support extended expiration dating for compounded sterile preparations to any patient or organization that request such documentation.(l) Each compounder shall perform studies to determine extended expiration dates, using evidence-based and validated stability testing procedures, for compounded sterile preparations for which no extended expiration evidence exists.(m) Each compounder shall have a policy that requires validation of new or changed facilities, equipment, processes, container types, for sterility, and repeatability.(n) Each compounder shall have a quality assurance program to promptly address equipment problems.(o) Each compounder shall have a quality assurance program for compounding that includes at least the following separate, but integrated, components:(2) Standard operating procedures;(6) Cleaning and disinfecting;(7) Containers, packaging and repackaging; and(p) Personnel involved in the compounding, evaluation, packaging and dispensing of compounded preparations shall be properly trained and evaluated to include: (1) Three glove fingertip tests shall be performed initially then annually for low and medium risk compounding; and(2) Three glove fingertip tests shall be performed initially then every 6 months for high risk compounding.(q) Personnel shall undergo re-qualification using media fills and glove fingertip tests annually for low and medium risk sterile compounding and every 6 months thereafter for high risk sterile compounding.(r) Each compounder shall have an action plan and alert limits for environmental monitoring.(s) Each compounder shall develop and implement methods for improving quality based on analyzed data found in its environmental monitoring.(t) Each compounder shall evaluate and continuously monitor the methods used for the packaging, handling, and transport of CSPs.(u) Each compounder shall evaluate and continuously monitor the storage of CSPs to ensure compliance with appropriate storage conditions.(v) Each compounder shall ensure drug storage refrigerators, freezers and medication storage areas have daily monitoring and documentation of temperatures.(w) Compounder personnel shall inspect all drug storage areas routinely to ensure drugs are stored separately from food.(x) Each compounder shall ensure all solutions, medications, equipment, and supplies located in all areas are stored according to the manufacturer or USP requirements and are inspected monthly for proper conditions of light, temperature, moisture, and ventilation.(y) Each compounder shall ensure all outdated and unused CSPs are segregated in a separate area for return and disposal.(z) Each compounder shall ensure only pharmacists training in sterile compounding determine whether a CSP not administered as originally intended can be used for an alternate patient or under alternate conditions.(aa) Each compounder shall have an environmental sampling plan based on the compounding activities performed, locations to be monitored, the device used to monitor, the frequency of collection, and procedures if readings exceed established thresholds.(ab) The 2 types of monitoring that shall be used are: (1) Non-viable monitoring which includes particle counts, monitoring pressure or velocity difference between the buffer area, ante area and non-classified area and shall be done at least every 6 months; and(2) Viable monitoring which detects microbial or fungal contaminants in the compounding area and shall be done using a volumetric collection method.(ac) Monitoring, sampling, and testing for surface contamination from hazardous drugs is conducted at least every month or earlier in cases of contamination from fluid or solid dosage form spills.(ad) Compounder shall ensure certification of its PEC complies with the requirements of USP Standards. Certification shall be done by an independent entity certified to perform the test. Each certifying entity shall leave a signed copy of the test with the compounder who shall retain the document for at least 4 years.(ae) Each compounder shall ensure the PEC is certified every 6 months or sooner if recommended by the manufacturer.(af) Each compounder shall ensure viable and non-viable airborne sampling occurs minimally every 6 months. Monitoring shall include all areas at risk of contamination including but not limited to inside of PEC, counters, anteroom, areas near doorways, and any pass-through, counters, storage areas, shelves, shipping and receiving areas, and employee work areas.(ag) Each compounder shall ensure sampling data is base-lined, evaluated and documented on a routine basis as defined by USP standards.(ah) Each compounder shall have a written plan and schedule for environmental monitoring.(ai) Each compounder shall have a written environmental plan that adequately evaluates the various controlled air environment areas including the PEC, buffer area, and anteroom.(aj) Compounder facility personnel, or external personnel, who complete the environmental monitoring shall be appropriately trained and certified by a national certification entity.N.H. Admin. Code § Ph 404.05
#6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05
Amended by Volume XXXV Number 18, Filed May 7, 2015 , Proposed by #10812, Effective 4/18/2015, Expires 4/18/2025.