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Evaluation of Outsourced 503A Compounding Pharmacy
Date of Review:
Company Name, Doing Business As:
Address:
City, State, Zip:
Hours of Operation:
Contact: Phone, Fax, Email:
Pharmacist In Charge:
Quality Review POC:
Demographics:
Regulatory Requirements
| The pharmacy has a current active pharmacy license and is in good standing from their Board of Pharmacy. | |
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Please Attach Copy
| The pharmacy is licensed to ship to my state (if other than the state in which the VAMC resides). | |
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| The Pharmacy applies the most current USP <797> standards. | |
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| The Pharmacy applies the most current USP <795> standards. | |
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| The Pharmacy applies the most current USP <800> standards. | |
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| The pharmacy complies with HIPAA standards. | |
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| The pharmacy is accredited through an accrediting organization for pharmacy compounding | | |
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| The pharmacy complies with federal and state EPA regulations related to disposal and handling of pharmaceutical and hazardous wastes per the RCRA provisions. | |
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| The pharmacy has documented through a Certificate of Analysis (CoA) or purchase orders of obtaining active pharmaceutical ingredients (APIs)* from an FDA-and/or DEA-registered pharmaceutical supplier with a Standard Operating Procedures to verify supplier registration status. | |
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| The pharmacy has a current Drug Enforcement (DEA) registration if compounding controlled substances products to VAMCs. | | |
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| All pharmacy staff (pharmacists) at the pharmacy are licensed and/or certified by their respective Boards of Pharmacy. | | |
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All patient specific CSPs prepared are documented to meet USP <797> standards of practice and the pharmacy is compliant the requirements of an FDA 503A outsourcing pharmacy.
All patient specific non-sterile compounded preparations prepared are documented to meet USP <795> standards of practice and the pharmacy is compliant the requirements of an FDA 503A outsourcing pharmacy.
| If this is a hospital pharmacy, the pharmacy is in good standing with The Joint Commission or their accreditation body. | |
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| If the hospital pharmacy received a “finding” from The Joint Commission or their accreditation body, the hospital has resolved the finding and will provide summary to VAMC. | |
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| The facility has been issued an FDA 483, warning letter, or other FDA violation notification. | |
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The facility has appropriately responded to FDA 483’s, warning letter or FDA violation notification and will share the corrective actions they have taken.
https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-action
| The facility has no pending Consent Decree related to compliance with FDA requirements. | |
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Procedural
| When no commercial source exists to prepare admixtures, the outsourcer uses USP grade bulk ingredients obtained from a cGMP compliant supplier and can provide a certificate of analysis and potency testing of all bulk ingredients used | |
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Attach Example
The pharmacy provided to the VAMC upon request during a site visit all documentation of accreditation and licensure, adverse reaction reports, medication error reports, recalls and patient incident reports, if feasible, in an un-redacted form.
If a site visit cannot be conducted, the pharmacy will provide this information on request.
| The pharmacy has documentation describing how CSPs will be prepared, including the CSPs are prepared from sterile or non-sterile components. | |
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| The pharmacy has established written policies and procedures to manage reporting of adverse reactions and end user problems to ensure tracking and trending of issues and resolution. | |
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| The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 or better-quality air using only sterile ingredients, products, components, and devices | |
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| Category 2 CSP BUD - In the absence of sterility tests, and prepared using sterile drugs products, controlled room temperature not more than 4 days, refrigerator not more than 10 days, freezer not more than 45 days. | |
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Category 2 Multiple Dose CSP BUD - In the absence of antimicrobial effectiveness testing, and prepared using sterile drugs products, controlled room temperature not more than 4 days, refrigerator not more than 10 days, freezer not more than 45 days. Once opened, CSP BUD not more than 24 hours at controlled room temperature or 72 hours if refrigerated.
If antimicrobial effectiveness testing has been conducted, documentation will be provided upon request.
| Beta-Lactam production is separate from other CSP production; if the same PEC is used for Beta Lactam production, the PEC is thoroughly cleaned before other CSPs are prepared. | |
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| Compounding manipulations are performed to minimize contact contamination of critical sites. | |
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| PECs are certified, maintained ISO Class 5 and located in an ISO Class 7 Sterile compounding space. | |
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| Sinks are not located adjacent to the ISO Class 5 PEC; sinks are separated from the immediate area of the ISO Class 5 PEC device | |
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| Quality assurance practices include routine disinfection and air quality testing, visual confirmation that personnel are appropriately garbing, review of all orders for correct identity and strength, and visual inspection of CSPs | |
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| Blood-derived or other biological material manipulations are clearly separated from routine material-handling procedures and equipment used in CSP preparation and are controlled by specific SOPs to avoid any cross-contamination. | |
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Cleaning
| For ISO Class 5, cleaning and disinfecting practices and policies exist. | |
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| LAFWs, BSCs, CAIs, and/or CACIs are cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods, when spills occur and when surface contamination is known or suspected | |
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| Work surfaces in ISO Class 7 buffer areas, ISO Class 7 or 8 ante-areas and segregated compounding areas are cleaned and disinfected at least daily, and dust and debris are removed, when necessary, from storage sites. | |
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| Floors in ISO Class 7 and 8 areas are cleaned daily when no compounding occurs; mopping is performed by trained personnel using approved agents and written procedures. | |
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| Clean area, ante-area and segregated compounding area, walls, ceilings, and shelving are cleaned with sporicidal agent and disinfected monthly | |
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| All cleaning materials are nonshedding and dedicated to use in the buffer or clean area, ante-area, and segregated areas and are not removed from these areas except for disposal | |
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| If cleaning materials are reused, SOPs ensure that the effectiveness of the cleaning device is maintained, and repeated use does not add to the bioburden of the area being cleaned | |
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| Sterile 70% IPA swabs do not contact any object before contacting the site to be cleaned. | |
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| No particle-generating material is used to disinfect the sterile entry points of packages and devices. | |
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| No shipping cartons are taken into the buffer area, clean area, or segregated compounding area. | |
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Personnel Training and Competency
| Prior to compounding, personnel are trained in garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5 conditions and cleaning and disinfections procedures. | |
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| Media-fill testing of aseptic work skills are performed initially before beginning to prepare CSPs and at least every 6 months thereafter for Category 2 compounding. | |
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| Personnel demonstrate proficiency of proper hand hygiene, garbing and consistent cleaning procedures in addition to didactic evaluation of aseptic media fill and glove tip testing. | |
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| Personnel are visually observed during the process of performing hand hygiene and garbing procedures and appropriately documented and maintained to provide a permanent record. | |
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| Personnel successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure no less than 3 times before initially being allowed to compound CSPs. | |
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| All compounding personnel have technique and competency evaluated initially during the Media-Fill Test Procedure and subsequent semi-annual Media-Fill Test Procedures. | |
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Finished Preparation Release Checks and Tests
| All CSPs are visually inspected for being intact with no abnormal particulate matter, and prescriptions and written compounding procedures are reviewed to verify accuracy of correct ingredients and amounts, aseptic mixing, high-risk sterilization, packaging, labeling, and expected physical appearance before they are administered or dispensed. | |
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| A double-check system is in place that meets state regulations that includes label accuracy and accuracy of the addition of all ingredients used. | |
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Quality Assurance Program
| Outsourced Compounding Pharmacy/Facility |
| Yes |
| No |
| Comments |
| A formal quality assurance program is in place that monitors, evaluates, corrects, and improves activities and processes. | |
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| Vendor provides routine and periodic QA assurance data upon the request of the VAMC. | |
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| The facility has a process in place to immediately notify the VAMC in the event of product recalls or significant situations that would compromise the product they provided to the VAMC. | |
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*Bulk Substances: State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that:
1. comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding.
2. are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or
3. appear on FDA’s list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist, and the substance is not a component of an FDA-approved drug product.
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