2.001

Designated Person for Nonsterile Compounding

This SOP defines the designated persons responsible for overseeing nonsterile compounding operations to ensure quality and patient safety per USP <795> requirements.

2.002

Orientation Program & Job Descriptions – Nonsterile Compounding

This SOP establishes orientation and training requirements for all nonsterile compounding personnel, including facility tours, job description review, and competency documentation to ensure staff understand their responsibilities and safety protocols.

2.003

Job Description - Pharmacist General and Nonsterile Compounding

This job description outlines the responsibilities, qualifications, and requirements for pharmacists performing general and nonsterile compounding operations, including patient counseling, prescription preparation, SOP development, and specialized compounding techniques.

2.004

Job Description - Technician General and Nonsterile Compounding

This job description defines the responsibilities, qualifications, and requirements for pharmacy technicians performing general and nonsterile compounding operations, including prescription processing, basic customer service, and equipment maintenance under pharmacist supervision.

2.005

Job Description - Certified Technician General and Nonsterile Compounding Copy

This job description outlines the enhanced responsibilities, qualifications, and requirements for certified pharmacy technicians (PTCB certified) performing general and nonsterile compounding operations, including advanced compounding tasks, oral prescription handling, and direct communication with healthcare providers.

2.006

Nonsterile Compounding Training and Evaluation

This SOP establishes comprehensive training and competency evaluation requirements for all nonsterile compounding personnel, including didactic learning, hands-on training, and annual assessments across various competency areas such as hand hygiene, cleaning procedures, and specific dosage form preparation.

2.007

Performance Audit - Nonsterile Lab Cleaning and Disinfection Procedures

This performance audit checklist evaluates personnel competency in proper cleaning and disinfection procedures for nonsterile compounding areas, covering daily tasks (hood cleaning, surface sanitization, floor mopping) and monthly deep cleaning requirements with documentation and evaluation criteria.

2.008

Performance Audit - Nonsterile Compounding

This comprehensive performance audit evaluates personnel competency in nonsterile compounding processes across multiple dosage forms (capsules, creams/lotions/gels, troches, suppositories, suspensions/solutions) including proper techniques, safety protocols, equipment use, labeling procedures, and cleaning/sanitization requirements.

2.009

Performance Audit - Garbing and Hand Hygiene for Nonsterile Compounding

This performance audit checklist evaluates personnel competency in proper garbing procedures and hand hygiene protocols for nonsterile compounding areas, covering entry requirements (clothing, jewelry restrictions, PPE donning sequence) and exit procedures (PPE removal and hand washing protocols).

3.001

Usual and Customary Pricing – Nonsterile Compounds

This SOP establishes consistent pricing procedures for nonsterile compounded prescriptions across different patient categories (cash, private insurance, Medicare/Medicaid, Workers Comp), defining price code formulas based on acquisition cost, dispensing fees, level of effort, and special order fees, with specific billing requirements and collection policies.

3.002

Patient Education for Nonsterile Compounds

This SOP establishes comprehensive patient counseling procedures for compounded medications, ensuring pharmacists provide required education on drug ingredients, side effects, administration instructions, storage conditions, and adverse event reporting while complying with OBRA '90 requirements and state pharmacy regulations for both in-person and mail-order dispensing.

3.003

Patient Drug Delivery, Shipping or Pick Up

This comprehensive SOP establishes procedures for secure delivery, shipping, and pickup of compounded medications while maintaining product integrity, including temperature control requirements, packaging specifications, signature protocols, tracking documentation, and contingency plans for delays or delivery issues across multiple distribution methods.

3.004

Drug Recall – Nonsterile Compounding

This comprehensive SOP establishes procedures for recalling compounded products due to safety concerns or ingredient recalls, including traceability requirements, patient/prescriber notification protocols, product quarantine procedures, regulatory reporting obligations, and documentation requirements to ensure patient safety and regulatory compliance.

4.001

Component Selection

This SOP establishes requirements for selecting components used in nonsterile compounding, specifying criteria for APIs and other ingredients including USP-NF compliance, FDA registration requirements, certificate of analysis verification, prohibited substances, and quality assurance measures to ensure component suitability and safety.

4.002

Component Vendor Selection and Verification

This comprehensive SOP establishes requirements for selecting and authenticating vendors for prescription drugs, OTC products, and APIs used in compounding, including DSCSA compliance procedures, vendor verification protocols, authentication documentation requirements, and criteria for identifying suspect or illegitimate products to ensure supply chain integrity and patient safety.

4.003

Component Receipt and Evaluation Including Reporting

This comprehensive SOP establishes procedures for receiving and evaluating all compounding components (APIs, prescription products, OTC products) including visual inspection protocols, transaction data verification, certificate of analysis review, quarantine procedures, and suspect/illegitimate product identification and reporting requirements to ensure supply chain integrity and patient safety under DSCSA compliance.

4.004

Destruction of Expired Compounded Preparations and Raw Materials

This SOP establishes procedures for managing expired compounded preparations and raw materials through FIFO inventory management, 60-day expiration monitoring, proper quarantine protocols, controlled substance disposal requirements via reverse distributors (Pharma Logistics), DEA Form 41 compliance, and comprehensive documentation including witnessed destruction records and certificates of destruction.

5.001

General Equipment Requirements and Management

This SOP establishes requirements for compounding equipment management including suitability verification, contamination prevention, equipment-specific SOPs for cleaning/maintenance/calibration, personnel training documentation, internal serial numbering systems, and Equipment Maintenance Log (EML) tracking to ensure equipment accuracy and regulatory compliance.

5.002

Equipment Maintenance Log

This Equipment Maintenance Log (EML) attachment provides a standardized documentation form for tracking all maintenance, calibration, and operational activities performed on compounding equipment, including equipment identification details, activity records, personnel accountability, and verification signatures to ensure regulatory compliance and quality assurance.

5.003

Equipment and Facility Maintenance for Nonsterile Compounding

This SOP establishes procedures for equipment and facility maintenance including routine maintenance documentation through Equipment Maintenance Logs (EML), unplanned maintenance protocols requiring equipment quarantine and Work Order generation, external repair personnel garbing requirements, designated person verification and approval processes, and comprehensive documentation tracking to ensure continued integrity of compounding operations.

5.004

Waterproof Keyboard Covers in Nonsterile Compounding Area

This SOP establishes procedures for waterproof keyboard cover usage in nonsterile compounding areas including mandatory cover implementation, daily cleaning protocols with disconnection requirements, sanitization procedures, and keyboard replacement protocols to reduce contamination risks on computer equipment used in compounding operations.

5.005

Calibration of Temperature Sensing Equipment

This SOP establishes the requirements for calibrating and verifying temperature sensing equipment annually or per manufacturer guidelines to ensure accurate monitoring, regulatory compliance, and patient safety.

5.006

Equipment - Powder Containment Hoods

This SOP establishes the requirements for the proper use and maintenance of powder containment hoods to ensure safe weighing, transfer, and compounding operations while protecting personnel and preventing contamination.

5.007

Equipment - Tube Sealer – Impulse Sealer AIE-200C

This SOP defines the procedures for operating and maintaining the impulse tube sealer to ensure proper sealing of materials, equipment longevity, and safe compounding practices in compliance with pharmacy standards.

5.008

Equipment - Hotplate Stirrer

This SOP establishes the requirements for using and maintaining hotplate stirrers—including procedures for direct and indirect heating, proper use of magnetic stir bars, adjustment of stirring speed, cleaning, and routine maintenance—to ensure safe operation, equipment reliability, and compliance with compounding standards.

5.009

Equipment - IKA Eurostar 60 Homogenizer

This SOP establishes procedures for operating, cleaning, and maintaining the IKA Eurostar 60 Homogenizer to ensure safe handling, effective emulsification, and consistent preparation of compounded medications.

5.011

Equipment - Jaansun Capsule Machine

This SOP outlines the use, calibration, and maintenance of the Jaansun Capsule Machine to ensure accurate capsule filling, proper equipment care, and compliance with compounding standards.

5.012

Equipment - DTP Tablet Press

This SOP establishes the procedures for operating, cleaning, and maintaining the DTP Tablet Press to ensure accurate tablet production, equipment reliability, and compliance with compounding quality standards.

5.013

Equipment - Rectal Rocket Mold

This SOP establishes the requirements for using and maintaining the Rectal Rocket Mold—including lubrication, assembly, filling, demolding, cleaning, and storage—to ensure proper function, consistent preparation quality, and compliance with compounding standards.

5.014

Equipment - Balance Scales

This SOP establishes the use, calibration, and maintenance requirements for balance scales to ensure accurate weighing, compliance with USP <41> and <1251>, and reliability in pharmaceutical compounding.

5.015

Equipment - Twin pH Meter

This SOP establishes procedures for the operation, calibration, and maintenance of the Twin pH Meter to ensure accurate pH measurement, proper documentation, and compliance with compounding quality standards.

5.016

Equipment - FlackTek Speedmixer

Provides procedures for the proper use, calibration, and maintenance of the FlackTek Speedmixer to ensure uniform, particle-free pharmaceutical preparations.

5.017

Equipment - Exakt Ointment Mill

This SOP defines the procedures for operating, cleaning, and maintaining the Exakt Three Roll Ointment Mill to ensure consistent compounding quality and equipment reliability in nonsterile preparations.

5.018

Equipement - Unguator EMP

This SOP establishes the procedures for operating, cleaning, and maintaining the Unguator EMP Mixing System to ensure safe handling, effective emulsification, and consistent preparation of compounded medications.

5.019

Power Failure

This SOP outlines the procedures for responding to power failures, including communication, safety precautions, equipment protection, and restoration of normal operations to ensure continuity and security within the pharmacy.

5.02

Refrigerator / Freezer Failure

This SOP outlines procedures for responding to refrigerator and freezer failures, including temperature monitoring, product protection, and corrective actions to ensure medication integrity and compliance.

5.021

HVAC Failure

This SOP outlines procedures for responding to HVAC failures to protect personnel safety and product integrity, including immediate vendor notification, temperature/ventilation controls, and suspension of compounding activities as needed.

5.022

Response to Equipment Failures

This SOP outlines procedures for identifying, labeling, documenting, and repairing equipment failures, including communication with vendors and monitoring after repair to ensure safe and reliable operation.

5.023

Equipment - ProFiller 3600 Capsule Machine

This SOP establishes the procedures for operating, cleaning, and maintaining the ProFiller 3600 Capsule Machine to ensure accurate capsule filling, equipment reliability, and compliance with compounding standards.

6.001

Non-Sterile Compounding Area Requirements

This SOP establishes the requirements for designating, equipping, and maintaining the non-sterile compounding area—including CVE use, storage practices, sanitation, and temperature/humidity controls—to prevent cross-contamination, protect personnel, and ensure USP <795> compliance.

6.002

Cleaning & Maintenance of the Non-Sterile Compounding Area

This SOP establishes the requirements for cleaning, sanitizing, and maintaining non-sterile compounding areas—including work surfaces, floors, equipment, and environmental controls—by defining daily, weekly, and monthly tasks, proper use of cleaning agents, and documentation practices to ensure personnel safety, prevent contamination, and maintain USP <795> compliance.

6.003

General Infection Control in Nonsterile Compounding

This SOP establishes the requirements for infection prevention and control in non-sterile compounding—including employee health screening, hand hygiene, workstation and restroom sanitation, proper gowning, and use of disinfectants—to minimize the risk of contamination, prevent transmission of infectious agents, and ensure compliance with regulatory standards

6.004

Preparation, Component, and Device Storage Conditions

This SOP establishes the requirements for storing pharmaceutical components, devices, and compounded preparations—including controlled access, temperature and humidity monitoring, quarantine procedures, and corrective action for excursions—to prevent contamination, ensure product integrity, and maintain compliance with USP standards.

6.005

Component Handling Spill and Disposal

This SOP establishes the requirements for handling, evaluating, and disposing of compounding components—including inspection for quality, proper storage practices, spill response procedures, use of spill kits, and documentation—to prevent contamination, ensure safety, and maintain compliance with USP <795>.

7.001

Workflow Procedures

This SOP establishes the requirements for prescription processing in non-sterile compounding—including order intake, verification, compounding, quality checks, labeling, batching, and dispensing—to ensure product legitimacy, regulatory compliance, and accurate delivery to patients.

7.002

General Process

This SOP establishes the requirements for proper compounding technique—including workspace disinfection, gowning, hygiene practices, equipment use, documentation, and quality checks—to minimize contamination, ensure accuracy, and maintain compliance with USP standards.

7.003

Garbing and Hand Hygiene for Nonsterile Compounding

This SOP establishes the requirements for garbing and hand hygiene—including removal of personal items, proper sequencing of PPE, handwashing, glove disinfection, and gowning practices—to protect compounded preparations from contamination and ensure compliance with USP <795>

7.004

Master Formula Record (MFR) and Compounding Record (CR)

This SOP establishes the requirements for creating, maintaining, and reviewing Master Formula Records (MFRs) and Compounding Records (CRs)—including documentation of ingredients, calculations, compounding steps, quality checks, beyond-use dating, and deviations—to ensure traceability, reproducibility, and compliance with USP <795> and state board requirements.

7.005

Beyond-Use-Dating (BUD) of Nonsterile Compounded Preparations

This SOP establishes the requirements for assigning beyond-use dates (BUDs) to non-sterile compounded preparations—including consideration of dosage form, water activity, container-closure compatibility, component expiration, and stability data—to ensure product integrity, patient safety, and compliance with USP <795>

7.006

Labeling of Compounded Nonsterile Preparations

This SOP establishes the requirements for labeling compounded non-sterile preparations—including prescription and batch label elements, auxiliary warnings, beyond-use dating, storage conditions, and patient-centered communication—to ensure clarity, prevent errors, and maintain compliance with USP <795> and state regulations.

7.007

Release Checks

This SOP establishes the requirements for performing release inspections of compounded non-sterile preparations—including verification of prescriptions, label accuracy, container integrity, visual inspection for incompatibilities, review of compounding records, and documentation—to ensure product quality, patient safety, and compliance with USP <795>.

7.008

Nonsterile Compounding Finished Preparation Testing

This SOP establishes the requirements for testing finished non-sterile compounded preparations—including visual inspection, weight and volume checks, potency verification, pH testing, and third-party analytical testing—to ensure accuracy, consistency, and compliance with USP <795> and state board requirements.

7.009

Nonsterile Compounding Process Validation

This SOP establishes the requirements for validating non-sterile compounding processes—including scheduled potency testing, documentation of results, personnel validation, and corrective action for deviations—to ensure accuracy, reproducibility, and compliance with USP <795>.

7.01

Dosage Form - Capsules General

This SOP establishes the requirements for compounding capsules—including calculation of ingredient weights, proper use of capsule machines, powder blending, quality control weight testing, documentation of packing statistics, and corrective actions for deviations—to ensure uniformity, accuracy, and compliance with USP <795>.

7.012

Dosage Form - Oral Solution

This SOP establishes the requirements for compounding oral solutions—including ingredient verification, dissolution techniques, use of appropriate diluents and preservatives, quality control checks, and storage conditions—to ensure accuracy, stability, and compliance with USP <795>.

7.013

Dosage Form - Oral Suspension

This SOP establishes the requirements for compounding oral suspensions—including ingredient selection, particle size reduction, wetting and mixing techniques, pH adjustment, and labeling with storage and shake-well instructions—to ensure uniform dosing, stability, and compliance with USP standards.

7.014

Dosage Form - Troche

This SOP establishes the requirements for compounding troches—including ingredient weighing, base melting, powder incorporation, mold calibration, flavoring, polishing, and quality control weight testing—to ensure uniformity, accuracy, and compliance with USP standards.

7.015

Dosage Form – Enemas

This SOP establishes the requirements for compounding enemas—including ingredient measurement, mixing techniques for solutions and suspensions, pH adjustment, filling into enema bottles, and labeling—to ensure accuracy, stability, and compliance with USP <795>.

7.016

Dosage Form - Gel, Cream, Lotion

This SOP establishes the requirements for compounding semi-solid preparations—including ointments, creams, gels, lotions, and pastes—covering ingredient preparation, levigation, geometric dilution, heating and cooling techniques, packaging, and labeling to ensure uniformity, stability, and compliance with USP standards.

7.017

Dosage Form - PLO Gel

This SOP establishes the requirements for compounding Pluronic Lecithin Organogel (PLO Gel)—including phase mixing, drug incorporation, equipment use, shearing techniques, storage conditions, and labeling—to ensure uniformity, stability, and compliance with USP standards.

7.018

Dosage Form - Suppositories

This SOP establishes the requirements for compounding suppositories—including selection of appropriate bases, calculation of density displacement, use of molding and fusion techniques, mold calibration, quality control weight testing, and packaging—to ensure accuracy, consistency, and compliance with USP standards.

7.019

Dosage Form - Urethral Gel

This SOP establishes the requirements for compounding urethral gels—including ingredient measurement, syringe preparation, mixing with luer-lock adapters, incorporation of gel bases, refrigeration for gelling, and labeling—to ensure accuracy, stability, and compliance with USP <795>.

7.02

Dosage Form – Rectal Rocket

This SOP establishes the requirements for compounding rectal rockets—including mold lubrication, assembly, pouring techniques, drying, polishing, demolding, packaging, and labeling—to ensure accurate dosing, stability, and compliance with USP <795>.

7.021

Dosage Form – Rapid Dissolve Tablets

This SOP establishes the requirements for compounding Rapid Dissolve Tablets (RDTs)—including powder preparation, mold calibration, pressing, oven curing, demolding, polishing, blister packaging, and labeling—to ensure uniformity, stability, and compliance with USP standards.

8.001

Quality Program Requirements

This SOP establishes the requirements for the pharmacy’s quality program—including quality assurance (QA), quality control (QC), and performance improvement (PI) activities such as complaint tracking, incident reporting, personnel competency, equipment calibration, data analysis, corrective actions, and annual review—to ensure continuous improvement, patient safety, and compliance with USP <795> and state regulations.

8.002

Good Documentation Practices (GDP)

This SOP establishes the requirements for Good Documentation Practices (GDP)—including permanent, legible, and accurate recordkeeping, error correction, signatures, traceability, and proper handling of quality records such as MFRs, CRs, training logs, equipment maintenance, and cleaning records—to ensure data integrity, regulatory compliance, and USP <795> adherence.

8.003

Incidents, Complaints and Adverse Events

This SOP establishes the requirements for identifying, documenting, investigating, and resolving incidents, complaints, and adverse events—including reporting timelines, patient and prescriber notification, corrective actions, and record retention—to ensure patient safety, quality assurance, and compliance with USP <795> and regulatory requirements.

8.004

Corrective Action Procedures

This SOP establishes the requirements for implementing corrective actions—including review of regulatory inspection observations, documentation gathering, root cause analysis, SOP revisions, development of action plans, assignment of responsibilities, and reporting—to ensure timely remediation, continuous improvement, and compliance with USP and regulatory standards.

8.005

Accounting for Product Loss in Topical Pump Dispensers

This SOP establishes the requirements for accounting for product loss in topical pump dispensers—including validation of priming and irretrievable volumes, calculation of overfill quantities, documentation in compounding records, verification of pump type, and QA review—to ensure accurate dosing, consistency, and compliance with USP <795>.

1.001

Sterile Compounding

This SOP establishes the requirements for sterile compounding—including facility and personnel responsibilities, CSP categories, PEC and SEC use, training, documentation, and adherence to USP <797>—to minimize contamination risks, ensure product sterility, and protect patient safety.

2.001

Designated Person(s) for Sterile Compounding

This SOP establishes the requirements for designating and empowering qualified personnel to oversee sterile compounding—including training, competency assessments, facility and equipment oversight, component selection, sterilization activities, QA/QC program management, and corrective action—to ensure patient safety, quality assurance, and compliance with USP <797>.

2.002

Orientation Program & Job Descriptions (Sterile Compounding)

This SOP establishes the requirements for orientation and job descriptions for sterile compounding personnel—including facility tours, training on SOPs, job-specific responsibilities, controlled substance diversion training, OSHA/SDS education, and signed acknowledgment of job descriptions—to ensure staff preparedness, accountability, and compliance with USP <797>.

2.003

Job Description: Pharmacist (General and Sterile Compounding)

This SOP establishes the job description for pharmacists in sterile compounding—including responsibilities for prescription verification, formulation development, direct patient and provider communication, compounding of sterile dosage forms, inventory oversight, equipment maintenance, staff supervision, and adherence to SOPs—to ensure accuracy, quality assurance, and compliance with USP <797>.

2.004

Job Description: Pharmacy Technician (General and Sterile Compounding)

This SOP establishes the job description for pharmacy technicians in sterile compounding—including responsibilities for prescription processing, preparation of sterile and nonsterile dosage forms, labeling, inventory management, equipment cleaning, customer service, and adherence to SOPs—to ensure safe practices, quality assurance, and compliance with USP <797>.

2.005

Job Description: Certified Pharmacy Technician (General and Nonsterile Compounding)

This SOP establishes the job description for certified pharmacy technicians in nonsterile compounding—including responsibilities for prescription processing, compounding of nonsterile and select sterile preparations, labeling, inventory control, equipment maintenance, communication with prescribers, and adherence to SOPs—to ensure accuracy, quality assurance, and compliance with USP standards.

2.006

Sterile Compounding Training and Evaluation

This SOP establishes the requirements for training and competency evaluation of sterile compounding personnel—including initial and ongoing didactic training, garbing and hand hygiene, aseptic technique, gloved fingertip and thumb sampling, media fill testing, surface sampling, and cleaning/disinfection competencies—to ensure staff proficiency, contamination control, and compliance with USP <797>.

2.007

Sterile Garbing and Hand Hygiene Observational Competency

This SOP establishes the requirements for evaluating personnel competency in sterile garbing and hand hygiene—including restrictions on personal items, stepwise donning of PPE, proper handwashing and glove application, and correct doffing procedures—to ensure contamination control, personnel safety, and compliance with USP <797>.

2.008

Sterile Aseptic Technique Competency

This SOP establishes the requirements for evaluating personnel competency in aseptic technique—including proper garbing, PEC preparation, first-air protection, disinfection of critical sites, syringe and vial handling, glove disinfection, waste disposal, sterilization methods, and PEC cleaning—to ensure contamination control, product sterility, and compliance with USP <797>.

2.009

Sterile Cleaning and Disinfection Competency

This SOP establishes the requirements for evaluating personnel competency in sterile cleaning and disinfection—including proper garbing, use of sterile agents and wipes, clean-to-dirty workflow, PEC and buffer area cleaning, dwell times, surface and equipment disinfection, and documentation of daily, weekly, and monthly tasks—to ensure contamination control, environmental quality, and compliance with USP <797>.

2.01

Sterile Compounding Competency Test

This SOP establishes the requirements for administering and evaluating the Sterile Compounding Competency Test—including written assessment of SOP knowledge, aseptic technique, garbing, cleaning, equipment use, documentation, quality assurance, and regulatory compliance—with a required passing score of 90% to ensure personnel proficiency, accountability, and adherence to USP <797>.

3.001

Usual and Customary Pricing (Sterile Compounds)

This SOP establishes the requirements for determining usual and customary pricing for sterile compounded prescriptions—including use of acquisition cost, dispensing fees, level of effort, special-order fees, and predefined pricing structures for cash, insurance, Medicare/Medicaid, and workers’ compensation patients—to ensure consistency, transparency, and compliance with pharmacy standards.

3.002

Patient Education

This SOP establishes the requirements for patient and caregiver education regarding compounded preparations—including mandatory counseling offers, review of side effects, drug interactions, dosing appropriateness, OBRA ’90 compliance, provision of written instructions and MedGuides, and counseling for mailed prescriptions—to ensure patient understanding, safe use, and regulatory compliance.

3.003

Patient Drug Delivery, Shipping, or Pick-Up (Sterile Compounding)

This SOP establishes the requirements for delivering, shipping, and dispensing compounded sterile preparations—including packaging integrity, cold-chain management, tamper-evident seals, delivery logs, shipping documentation, patient counseling offers, handling of delays or losses, and vehicle/driver maintenance checks—to ensure product quality, patient safety, and compliance with USP <797> and state regulations.

3.004

Drug Recall (Sterile Compounding)

This SOP establishes the requirements for conducting drug recalls in sterile compounding—including traceability of ingredients and preparations, classification of recalls (Class I–III), notification of patients and prescribers, quarantine of affected products, documentation of lot numbers, recall letters, investigation of causes, corrective training, and regulatory reporting—to ensure patient safety, product accountability, and compliance with FDA, USP <797>, and board of pharmacy standards.

4.001

Component Selection (Sterile Compounding)

This SOP establishes the requirements for selecting components used in sterile compounding—including verification of APIs through USP–NF monographs, certificates of analysis, and FDA-registered sources; exclusion of withdrawn or unsafe drugs; adherence to FDA guidance on biologics; and qualification of excipients and container systems—to ensure ingredient quality, patient safety, and compliance with USP <797> and FDA regulations.

4.002

Component Vendor Selection and Verification (Sterile Compounding)

This SOP establishes the requirements for selecting and verifying component vendors—including authentication of manufacturers, repackagers, and wholesale distributors; compliance with DSCSA and FDA registration; review of licenses, accreditations, and warning letters; evaluation of APIs, excipients, and OTC vendors; and ongoing vendor monitoring—to ensure product integrity, prevent counterfeit or diverted drugs, and maintain compliance with USP <797> and federal regulations.

4.003

Component Receipt and Evaluation Including Reporting (Sterile Compounding)

This SOP establishes the requirements for receiving and evaluating compounding components—including quarantine on receipt, visual inspection for tampering, review of transaction data, verification of invoices, lot numbers, expiration dates, and Certificates of Analysis (COAs), handling of APIs, OTCs, growth media, and reporting of suspect or illegitimate products to the FDA and trading partners—to ensure product integrity, patient safety, and compliance with USP <797>, DSCSA, and FDA regulations.

4.004

Destruction of Compounded Preparations and Raw Materials

This SOP establishes the requirements for destroying expired, damaged, or unusable compounded preparations and raw materials—including monthly inventory checks, quarantine procedures, documentation on inventory logs, reverse distributor or vendor use, DEA Form 41 reporting for controlled substances, and signed/witnessed destruction methods—to ensure accountability, regulatory compliance, and patient safety.

5.001

General Equipment and Maintenance

This SOP establishes the requirements for creating, maintaining, and following equipment-specific procedures—including cleaning, calibration, verification, maintenance, labeling with internal serial numbers, and documentation in Equipment Maintenance Logs (EMLs)—to ensure safe operation, equipment reliability, and compliance with USP <797>.

5.002

Equipment Maintenance and Calibration Log (EML)

This SOP establishes the requirements for documenting equipment maintenance and calibration—including recording serial numbers, make, model, manufacturer details, scheduled maintenance, calibration activities, responsible personnel, and verification checks—to ensure traceability, equipment reliability, and compliance with USP <797>.

5.003

Equipment and Facility Repair for Sterile Compounding

This SOP establishes the requirements for equipment, facility, and utility repairs in sterile compounding—including initiation of work orders, equipment quarantine, documentation in EMLs, external repair personnel garbing, verification of post-repair functionality, recertification if needed, and final approval by the designated person or PIC—to ensure equipment reliability, facility integrity, and compliance with USP <797>.

5.004

Waterproof Keyboards in Sterile Compounding Area

This SOP establishes the requirements for using and maintaining waterproof keyboards in sterile compounding areas—including daily cleaning with soapy water and sanitizing agents, disconnection before cleaning, and replacement when necessary—to reduce contamination risks, protect product integrity, and ensure compliance with USP <797>.

5.005

Calibration of Temperature Sensing Equipment (Sterile Compounding)

This SOP establishes the requirements for calibrating temperature monitoring equipment—including thermometers, electronic sensors, autoclaves, ovens, and incubators—through annual calibration or verification using NIST-traceable devices, external vendors, or replacement with calibrated sensors, with documentation maintained in the Equipment Maintenance and Calibration Log (EML), to ensure accuracy, reliability, and compliance with USP <797>.

5.006

Equipment - Scales and Balances

This SOP establishes the requirements for using and maintaining scales and balances—including routine calibration every six months, cleaning after each use, logging maintenance and repairs in the Equipment Maintenance Log (EML), and following manufacturer instructions—to ensure measurement accuracy, equipment reliability, and compliance with USP <797>.

5.007

Equipment - Containment Ventilated Enclosure (CVE)

This SOP establishes the requirements for using and maintaining Containment Ventilated Enclosures (CVEs)—including certification every six months, cleaning after each use, proper placement in ISO Class 8 or better areas, documentation in the Equipment Maintenance Log (EML), and repair/maintenance per SOP 5.003—to minimize airborne contamination risks, protect personnel, and ensure compliance with USP <797>.

5.008

Equipment - Laminar Air Flow Workbench (LAFW)

This SOP establishes the requirements for using and maintaining Laminar Air Flow Workbenches (LAFWs)—including semiannual certification, cleaning after each use, proper placement in SCAs or cleanroom suites depending on CSP category, viable air and surface sampling, documentation in Equipment Maintenance Logs (EMLs), and repairs per established procedures—to ensure contamination control, product sterility, and compliance with USP <797>.

5.014

Equipment - Filter Integrity Testing Equipment

This SOP establishes the requirements for using and maintaining filter integrity testing equipment—including annual calibration, cleaning after each use with 70% IPA, storage in controlled environments, pre-use function checks, periodic tubing replacement, operation of bubble point testing, documentation in Equipment Maintenance Logs (EMLs), and repair per established procedures—to ensure accurate filter performance verification, equipment reliability, and compliance with USP <797>.

6.001

Sterile Compounding Area Requirements

This SOP establishes the requirements for sterile compounding areas—including design and maintenance of SCAs, cleanrooms, anterooms, and buffer rooms; PEC and SEC placement; pressure differentials; environmental monitoring; quarantine procedures; and facility certification—to ensure contamination control, product sterility, and compliance with USP <797>.

6.002

Monitoring Sterile Compounding Areas

This SOP establishes the requirements for monitoring sterile compounding areas—including daily recording of temperature, humidity, and pressure differentials; continuous or retroactive excursion detection; monthly or weekly viable surface sampling; semiannual or monthly viable air sampling; and certification of PECs and SECs every six months—to ensure environmental control, product integrity, and compliance with USP <797> and CETA guidelines.

6.003

Certification of PECs and SECs

This SOP establishes the requirements for certification of primary and secondary engineering controls (PECs and SECs)—including semiannual testing by qualified certifiers, verification of pressure differentials, airflow velocity, HEPA filter integrity, particle counts, and recertification after repairs or relocation—to ensure environmental control, contamination prevention, and compliance with USP <797>.

6.004

Viable Air Sampling

This SOP establishes the requirements for viable air sampling in sterile compounding areas—including use of volumetric impaction samplers, TSA and SDA/MEA media, defined sampling locations (PECs, buffer rooms, anterooms, passthroughs), incubation at specified temperatures, documentation of CFU results, and corrective actions for alert and action level excursions—to ensure environmental quality, contamination control, and compliance with USP <797> and <1116>.

6.005

Viable Surface Sampling

This SOP establishes the requirements for viable surface sampling in sterile compounding areas—including monthly or weekly sampling frequency based on CSP category, use of TSA and SDA media with neutralizers, defined sampling sites in PECs and SECs, incubation at specified temperatures, documentation of CFU counts, corrective actions for alert/action level excursions, and microorganism identification when needed—to ensure contamination control, environmental quality, and compliance with USP <797> and <1116>.

6.006

Cleaning and Disinfection of Sterile Compounding Areas

This SOP establishes the requirements for cleaning and disinfecting sterile compounding areas—including daily, weekly, and monthly schedules for PECs, SECs, floors, walls, ceilings, shelving, sinks, and reusable garb; use of EPA-registered cleaning, disinfecting, and sporicidal agents; adherence to dwell times; final IPA residue removal; and documentation on cleaning logs—to ensure contamination control, environmental quality, and compliance with USP <797>.

6.007

Sterile Compounding Area Cleaning Log

This SOP establishes the requirements for documenting cleaning and disinfection of sterile compounding areas—including chronological log entries with personnel initials, daily/weekly/monthly activity tracking, use of “NA” for non-applicable tasks, review by designated persons, and correction of deficiencies—to ensure accountability, traceability, and compliance with USP <797> and Good Documentation Practices.

6.008

Component Handling, Spill, and Disposal (Sterile Compounding)

This SOP establishes the requirements for handling, storing, and disposing of sterile compounding components—including inspection and verification before use, proper storage conditions with monitoring, prevention of contamination or mix-ups, documentation and quarantine of rejected components, spill management with trained personnel and spill kits, and disposal through reverse distributors—to ensure safety, product integrity, and compliance with USP <797>.

7.001

General Aseptic Technique

This SOP establishes the requirements for aseptic technique in sterile compounding—including movement and decontamination of supplies, maintenance of first air in PECs, prevention of contamination through personnel practices, proper use of syringes and needles, handling of sterile products and containers, and restrictions on multiple- and single-dose vials—to ensure product sterility, patient safety, and compliance with USP <797>.

7.002

Garbing and Hand Hygiene for Sterile Compounding

This SOP establishes the requirements for personal hygiene, garbing, and hand hygiene in sterile compounding—including removal of personal items, inspection for health conditions, donning of shoe, hair, face, and beard covers, surgical masks, gowns, and sterile gloves, use of alcohol-based hand rub, and proper doffing procedures—to minimize contamination risks, protect personnel, and ensure compliance with USP <797>.

7.003

Gloved Fingertip and Thumb Testing

This SOP establishes the requirements for gloved fingertip and thumb sampling—including initial and ongoing competency testing, use of TSA media with neutralizers, incubation at specified temperature ranges, documentation of results, action levels for CFU counts, and remediation for failed tests—to verify garbing and aseptic technique proficiency and ensure compliance with USP <797>.

7.004

Media Fill Testing

This SOP establishes the requirements for media fill testing—including initial and ongoing qualification of sterile compounding personnel, simulation of aseptic manipulations using soybean–casein digest media, incubation at defined temperature ranges, documentation of results, failure criteria based on turbidity, and remediation for unsuccessful tests—to verify aseptic technique competency and ensure compliance with USP <797>.

7.005

Master Formula and Compounding Record

This SOP establishes the requirements for creating, maintaining, and reviewing Master Formula Records (MFRs) and Compounding Records (CRs)—including documentation of components, calculations, preparation steps, container systems, quality control checks, beyond-use dating, deviations, and pharmacist verification—to ensure traceability, reproducibility, and compliance with USP <797> and state board requirements.

7.006

Beyond-Use Dating (BUD) of Sterile Compounded Preparations

This SOP establishes the requirements for assigning beyond-use dates (BUDs) to sterile compounded preparations—including Category 1, 2, and 3 CSP distinctions; aseptic processing vs. terminal sterilization; stability and sterility considerations; storage condition limits; sterility, stability, particulate, and container-closure testing for Category 3 CSPs; and documentation in MFRs and CRs—to ensure product integrity, patient safety, and compliance with USP <797>.

7.007

Labeling of Compounded Sterile Preparations

This SOP establishes the requirements for labeling compounded sterile preparations—including prescription-specific and batch label elements, active ingredients, dosage form, strength, beyond-use date, storage conditions, auxiliary warnings, patient-specific details for inpatient and outpatient use, and patient-centered communication standards—to ensure clarity, prevent errors, and maintain compliance with USP <797> and state regulations.

7.008

Release Checks and Tests for CSPs

This SOP establishes the requirements for release checks and testing of compounded sterile preparations (CSPs)—including visual inspection for particulates, incompatibilities, and container integrity; verification of labeling and compounding records; sterility testing per USP <71>; endotoxin testing per USP <85>; documentation of pH, potency, and other quality checks; and investigation of out-of-specification results—to ensure product safety, quality, and compliance with USP <797>.

7.009

Sterilization by Filtration

This SOP establishes the requirements for sterilization by filtration—including use of sterile 0.22 µm or smaller filters, prefiltration for particulate removal when necessary, documentation of filter lot numbers and expiration dates, aseptic filtration within ISO Class 5 PECs, and post-filtration bubble point integrity testing—to ensure microbial retention, product sterility, and compliance with USP <797>.

7.011

CSPs for Immediate Use

This SOP establishes the requirements for compounding sterile preparations for immediate use—including training and competency of personnel in aseptic technique and cleaning, use of no more than three sterile products, proper hand hygiene and garbing, aseptic compounding outside PECs/SECs, labeling with ingredients and administration timeframe when required, and administration within four hours—to ensure product safety, sterility, and compliance with USP <797>.

8.001

Quality Program Requirements (Sterile Compounding)

This SOP establishes the requirements for the sterile compounding quality program—including quality assurance (QA), quality control (QC), and performance improvement (PI) activities such as personnel training, equipment calibration, environmental monitoring, complaint and incident review, patient satisfaction surveys, data trending, corrective action planning, and annual program evaluation—to ensure patient safety, continuous improvement, and compliance with USP <797> and <1163>.

8.002

Good Documentation Practices (GDP)

This SOP establishes the requirements for Good Documentation Practices (GDP)—including permanent, legible, and accurate recordkeeping; real-time entries with signatures and dates; correction of errors without obscuring original data; use of official forms and signature logs; documentation of personnel training, environmental monitoring, equipment maintenance, component receipt, release testing, and complaints—to ensure traceability, data integrity, and compliance with USP <797>, state, and federal regulations.

8.003

Incidents, Complaints, and Adverse Events (Sterile Compounding)

This SOP establishes the requirements for identifying, documenting, investigating, and responding to incidents, complaints, and adverse events—including immediate documentation on incident or complaint forms, defined reporting timelines, root cause analysis, prescriber and patient notification when appropriate, corrective actions, and review by the quality committee—to ensure patient safety, accountability, and compliance with USP <797>.

8.004

Incident Reporting

This SOP establishes the requirements for documenting and investigating pharmacy incidents—including completion of detailed incident report forms, identification of error types (e.g., incorrect drug, strength, dosage form, directions, or labeling), documentation of contributing factors, notification of prescribers and patients, assessment of outcomes, quality assurance review, and implementation of corrective actions—to ensure accountability, patient safety, and compliance with USP <797> and regulatory standards.

9.001

Hazardous Drugs List and Assessment of Risk

This SOP establishes the requirements for developing, maintaining, and annually updating the hazardous drugs (HD) list and assessment of risk—including identification of HDs per NIOSH and USP <800>, documentation of dosage forms, hazard categories, risks of exposure, containment strategies, and alternative handling practices—to ensure personnel safety, regulatory compliance, and safe compounding operations.

9.002

Hazard Communication Program

This SOP establishes the requirements for the pharmacy’s Hazard Communication Program—including hazardous chemical determination, maintenance of the hazardous drug list, staff training, safety precautions, reference to related SOPs for receiving, transport, storage, compounding, cleaning, spill response, and disposal—to ensure employee awareness, safe handling, and compliance with OSHA and USP <800>.

9.003

Hazardous Drug Personnel Training

This SOP establishes the requirements for training and competency assessments of personnel handling hazardous drugs—including orientation to the Hazard Communication Program, PPE use, spill management, engineering controls, receiving, storage, packaging, transport, and compounding—to ensure staff proficiency, workplace safety, and compliance with USP <800>.

9.004

Acknowledgement - Handling of HDs

This SOP establishes the requirements for personnel acknowledgement of hazardous drug risks—including completion of training and competency assessments, annual re-acknowledgement, and signed documentation of understanding regarding potential health effects, SOP compliance, and safe handling practices—to ensure staff accountability, awareness, and compliance with USP <800>.

9.009

Safety Data Sheets

This SOP establishes the requirements for maintaining and training personnel on the use of Safety Data Sheets (SDS)—including annual binder review, addition of SDS for new drugs and APIs, employee training on SDS location and interpretation, and use of SDS for PPE requirements, exposure response, and safe handling—to ensure hazard awareness, workplace safety, and compliance with OSHA and USP <800>.

9.01

PPE for Non-Sterile HD Compounding

This SOP establishes the requirements for personal protective equipment (PPE) when compounding non-sterile hazardous drugs—including gowning sequence, double gloving, use of N-95 masks, goggles, and shoe covers, as well as requirements for changing gloves and gowns—to ensure personnel protection, contamination control, and compliance with USP <800>.

9.011

Doffing PPE For Non-sterile HD Compounding

This SOP establishes the requirements for safely doffing personal protective equipment (PPE) after compounding non-sterile hazardous drugs—including removal of outer gloves, gown, shoe covers, hair and face covers, mask, and goggles, followed by handwashing—to prevent contamination, ensure personnel safety, and maintain compliance with USP <800>.

9.014

Respiratory Protection

This SOP establishes the requirements for respiratory protection when handling hazardous drugs—including fit testing, use of N-95 surgical masks for compounding and minor spills, and full facepiece respirators with multi-gas cartridges and P100 filters for large spills, decontamination, or airborne exposures—to ensure personnel safety and compliance with USP <800> and OSHA standards.

9.015

Emergency Eye Wash

This SOP establishes the requirements for placement, use, and maintenance of emergency eye wash stations—including location and accessibility standards, water flow and duration requirements, weekly inspections, personnel training, and incident response procedures—to ensure rapid decontamination, employee safety, and compliance with OSHA and USP <800>.

9.016

Receiving Hazardous Drugs

This SOP establishes the requirements for receiving hazardous drugs—including inspection of packages for damage, use of appropriate PPE, handling of leaks or spills, labeling, transfer to designated storage, and deactivation/decontamination of the receiving area—to ensure safe handling, personnel protection, and compliance with USP <800>.

9.017

Storage of Non-Sterile HDs and APIs

This SOP establishes the requirements for storing non-sterile hazardous drugs (HDs) and active pharmaceutical ingredients (APIs)—including segregation of inventory, temperature and humidity controls, use of externally vented negative pressure rooms with at least 12 ACPH, dedicated refrigeration/freezers, surface requirements, and disaster preparedness precautions—to ensure product integrity, personnel safety, and compliance with USP <800>.

9.019

Packaging Hazardous Drugs for Dispensing

This SOP establishes the requirements for packaging hazardous drugs for dispensing—including use of sealed plastic bags, sturdy outer containers for glass items, preference for original or unit-dose packaging, preparation of ready-to-administer injectables, and labeling per SOP 9.022—to ensure drug integrity, prevent contamination, protect patients and personnel, and maintain compliance with USP <800>.

9.02

Shipping of Hazardous Drugs

This SOP establishes the requirements for shipping hazardous drugs—including review of SDS transport information, assignment of UN numbers and hazard classes, packaging in UN-compliant or protective containers, labeling per DOT and carrier requirements, and documentation of procedures—to ensure safe transport, regulatory compliance, and protection of personnel and patients.

9.021

Transporting Hazardous Drugs

This SOP establishes the requirements for transporting antineoplastic hazardous drugs—including use of dedicated coolers and ice packs, sealed outer plastic bags, PPE during handling, spill kits in vehicles, and decontamination of reusable containers—to ensure safe delivery, minimize exposure risks, and maintain compliance with USP <800>.

9.022

Labeling of HD Stock Containers

This SOP establishes the requirements for labeling stock containers of hazardous drugs—including drug name and strength, manufacturer or repackager details, lot number, expiration or beyond-use date, and hazard warnings—to ensure traceability, proper identification, and compliance with USP <800>.

9.023

Equipment and Utensils for HD Drug Handling

This SOP establishes the requirements for equipment and utensils used in hazardous drug handling—including dedicated mortars and pestles, glassware, trays, spatulas, and mixing equipment—along with labeling, tagging, and deactivation/decontamination procedures after use to ensure safe handling, prevent cross-contamination, and maintain compliance with USP <800>.

9.024

Handling Finished and Exempt Dosage Forms

This SOP establishes the requirements for handling hazardous drug dosage forms exempt from full containment—including use of gloves, dedicated trays and utensils, visual inspection for leaks, limited counting/repackaging, and deactivation/decontamination of equipment—to ensure safe handling, minimize exposure risks, and maintain compliance with USP <800>.

9.025

Compound Techniques – Non-sterile Hazardous Drugs

This SOP establishes the requirements for compounding non-sterile hazardous drugs—including exclusive use of biological safety cabinets, preparation mat changes, controlled workflow, syringe and needle handling techniques, use of luer-lock fittings, prevention of aerosolization, and deactivation/decontamination of equipment and containers—to ensure personnel safety, contamination control, and compliance with USP <800>.

9.027

Using HD Facilities for Non-HD Compounding

This SOP establishes the requirements for performing non-hazardous compounding in hazardous drug facilities—including limiting use to essential circumstances, labeling finished preparations, applying protective outer wrappers, and including precautionary handling statements—to minimize cross-contamination risks and ensure compliance with USP <800>.

9.036

Deactivating, Decon. & Cleaning Non-Sterile HD Compounding Areas

This SOP establishes the requirements for deactivating, decontaminating, and cleaning non-sterile hazardous drug compounding areas—including daily, monthly, and equipment-specific schedules; use of Peridox RTU, wipes, and mops; cleaning order from ceilings to floors; and proper PPE—to minimize hazardous residue, prevent cross-contamination, and ensure compliance with USP <800>.

9.038

Deactivating and Cleaning Non-Sterile BSCS

This SOP establishes the requirements for deactivating, decontaminating, and cleaning non-sterile Biological Safety Cabinets (BSCs)—including daily cleaning, spill response, power loss or relocation procedures, use of Peridox RTU and detergent wipes, cleaning sequence for interior surfaces, and PPE requirements—to minimize hazardous residue, protect personnel, and ensure compliance with USP <800>.

9.039

Deactivating & Cleaning HD Receiving Areas

This SOP establishes the requirements for deactivating and cleaning hazardous drug (HD) receiving areas—including proper garbing, use of Peridox RTU and detergent wipes, stepwise cleaning techniques, and glove changes—to remove HD residues, protect personnel, and ensure compliance with USP <800>.

9.04

Deactivating and Cleaning HD Storage Areas

This SOP establishes the requirements for deactivating, decontaminating, and cleaning hazardous drug (HD) storage areas—including daily floor cleaning, monthly ceiling/wall/shelving/refrigerator cleaning, stepwise use of Peridox RTU, detergent, and water, proper PPE, and disposal of contaminated materials—to reduce HD residue, protect personnel, and ensure compliance with USP <800>.

9.041

Cleaning Hazardous Drug Spills

This SOP establishes the requirements for cleaning hazardous drug spills—including immediate area evacuation, PPE use, spill kit deployment, containment with absorbent materials, proper collection and disposal of contaminated debris, deactivation/decontamination of affected surfaces, incident reporting, and post-cleanup handwashing—to ensure personnel safety, contamination control, and compliance with USP <800>.

9.042

Hazardous Drug Spill Kits

This SOP establishes the requirements for hazardous drug spill kits—including selection, placement in receiving, storage, compounding, and shipping areas, annual inspections, immediate replacement after use, and personnel training on kit locations and contents—to ensure readiness for spill response, staff safety, and compliance with USP <800>.

9.043

Accidental Exposure to Hazardous Drugs

This SOP establishes the requirements for responding to accidental exposure to hazardous drugs—including immediate removal from the exposure site, contaminated clothing removal, flushing of eyes or skin, notification of the safety officer, review of SDS instructions, incident reporting, and referral to emergency care—to ensure rapid response, personnel safety, and compliance with USP <800>.

9.044

Disposal of Hazardous Drug Wastes

This SOP establishes the requirements for disposing of hazardous drug waste—including placement of red hazardous waste containers in compounding areas, segregation of PPE and contaminated materials, use of contracted waste disposal services, and adherence to OSHA and USP <800> standards—to ensure safe handling, environmental protection, and regulatory compliance.

9.045

General Hazardous Drug Competency Test

This SOP establishes the requirements for assessing personnel competency in hazardous drug handling—including administration of a general knowledge test, minimum passing score of 90%, integration with the pharmacy’s HD training program, and documentation of results—to ensure staff proficiency, accountability, and compliance with USP <800>.

9.046

Hazardous Drug Compounding Competency Test

This SOP establishes the requirements for assessing personnel competency in hazardous drug compounding—including administration of a compounding-specific test, minimum passing score of 90%, evaluation of facility setup, workflow practices, equipment placement, environmental controls, and deactivation/decontamination procedures—to ensure staff proficiency, safe practices, and compliance with USP <800>.

9.047

Deactivation and Decontamination Competency Test

This SOP establishes the requirements for assessing personnel competency in deactivation and decontamination of hazardous drug compounding areas—including knowledge of correct surface cleaning order, PPE use, frequency of decontamination, disposal of contaminated supplies, and application techniques—to ensure safe practices, staff proficiency, and compliance with USP <800>.

9.048

Hazardous Drug Spill Performance Audit

This SOP establishes the requirements for auditing personnel competency in managing hazardous drug spills—including direct observation of spill response, correct PPE use, containment techniques for liquid and powder spills, use of spill kit tools, deactivation/decontamination, proper PPE removal, and waste disposal—to ensure staff readiness, safe practices, and compliance with USP <800>.

9.049

Non-Sterile Hazardous Garbing Performance Audit

This SOP establishes the requirements for auditing personnel competency in donning and doffing PPE for non-sterile hazardous drug compounding—including proper sequencing of masks, caps, shoe covers, gowns, and double gloves, glove changes during compounding, and correct removal techniques—to ensure staff proficiency, contamination control, and compliance with USP <800>.

9.051

Engineering Control Performance Audit

This SOP establishes the requirements for auditing personnel competency in operating primary engineering controls for hazardous drug compounding—including proper use of pressure gauges, PEC alarms, sash positioning, material placement, airflow management, and deliberate manipulation techniques—to ensure safe practices, contamination control, and compliance with USP <800>.

9.052

Non-Sterile HD Compounding Performance Audit

This SOP establishes the requirements for auditing personnel competency in non-sterile hazardous drug compounding—including appropriate PPE use, PEC operation, preparation mat use, syringe handling techniques, contamination control measures, deactivation/decontamination of equipment and preparations, waste disposal, and labeling—to ensure safe practices, product quality, and compliance with USP <800>.

9.055

Deactivating & Disinfecting Non-Sterile HD Compounding Areas Performance Audit

This SOP establishes the requirements for auditing personnel competency in deactivating and disinfecting non-sterile hazardous drug compounding areas—including preparation of cleaning agents, proper PPE use, stepwise surface cleaning order, dwell time adherence, PEC and room decontamination, and correct waste disposal—to ensure safe practices, contamination control, and compliance with USP <800>.