Guidance Documents for Outsourcing of Compounded Sterile Products.docx

?.## Guidance Documents for Outsourcing of Compounded Sterile Products Issued March 01, 2021

VHA PBM Template: Evaluation of Outsourced 503A Compounding Pharmacies

**Please note, this checklist is a guide and is not intended to be all inclusive. Facilities should evaluate 503A pharmacies based on local need and circumstances.

DOING BUSINESS AS

Regulatory Requirements

The pharmacy has a current active pharmacy license and is in good standing from their Board of Pharmacy.

The pharmacy is licensed to ship to my state (if other than the state in which the VAMC resides).

The Pharmacy applies the current USP <797> standards.

The Pharmacy applies the current USP <797> standards.

The pharmacy complies with HIPAA standards.

The pharmacy complies with federal and state EPA regulations related to disposal and handling of pharmaceutical and hazardous wastes per the RCRA provisions.

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.

The pharmacy has a current Drug Enforcement (DEA) registration if compounding controlled substances products to VAMCs.

All pharmacy staff (pharmacists, technicians) at the pharmacy are licensed and/or certified by their respective Boards of Pharmacy.

All patient specific CSPs prepared are documented to meet USP <797> standards) of practice (whichever version they are practicing under) 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 (whichever version they are practicing under) 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.

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.

The facility has been issued an FDA 483, warning letter, or other FDA violation notification.

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.

VAMC may not acquire compounded preparations from a facility with a Consent Decree.

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

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 can 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.

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.

The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 or better-quality air using only sterile ingredients, products, components and devices

Low Risk-(Not applicable to CSPs prepared under Category 1 USP <797> 2019 version) -In the absence of sterility tests, BUDs assigned are compliant with USP <797> and are not more than 48 hours at controlled room temperature, 14 days at cold temperature (2 – 8 degrees C), and 45 days in a solid frozen state of -25° to -10° C.

Low and Medium Risk- In the absence of sterility tests, storage is not more than 30 hours at controlled room temperature, 9 days at cold temperature (2 – 8 degrees C), and 45 days in a frozen state of -25° to -10° C.

Category 2- 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.

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.

Compounding manipulations are performed to minimize contact contamination of critical sites.

PECs are certified, maintained ISO Class 5 and located in an ISO Class 7 Sterile compounding space.

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

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

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.

Cleaning

For ISO Class 5, cleaning and disinfecting practices and policies exist.

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

Work surfaces in ISO Class 7 buffer areas, ISO Class 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.

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.

Clean area, ante-area and segregated compounding area, walls, ceilings, and shelving are cleaned and disinfected monthly

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

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

Sterile 70% IPA swabs do not contact any object before contacting the site to be cleaned.

No particle-generating material is used to disinfect the sterile entry points of packages and devices.

No shipping cartons are taken into the buffer area, clean area or segregated compounding area.

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.

Media-fill testing of aseptic work skills are performed initially before beginning to prepare CSPs and at least annually thereafter for low- and medium-risk level.

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.

Personnel are visually observed during the process of performing hand hygiene and garbing procedures and appropriately documented and maintained to provide a permanent record.

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.

All compounding personnel have technique and competency evaluated initially during the Media- Fill Test Procedure and subsequent annual or semi-annual Media-Fill Test Procedures.

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.

A double-check system is in place that meets state regulations that includes label accuracy and accuracy of the addition of all ingredients used.

Quality Assurance Program

A formal quality assurance program is in place that monitors, evaluates, corrects and improves activities and processes.

Vendor provides routine and periodic QA assurance data upon the request of the VAMC.

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.

VAMC

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