D.2 VHA PBM.pdf
PDF 5 MB Posted
- Attached to
- Pharmacy Compounded Sterile Preparation (CSP) VISN 15 Federal contract opportunity
- Solicitation number
- 36C25526R0023
About this file
This file is an assessment guide and compliance checklist for Compounded Sterile Products (CSPs) prepared within Veterans Affairs Medical Centers (VAMCs) and outsourced compounding pharmacies. The guide establishes regulatory requirements and quality standards that both outsourced compounding facilities and VAMC in-house pharmacies must meet to safely prepare and distribute CSPs.
The assessment covers multiple compliance domains organized into distinct sections: Regulatory Requirements address HIPAA compliance, EPA/RCRA waste handling, pharmacy accreditation (PCAB), API sourcing from FDA/DEA-registered suppliers, DEA registration for controlled substances, staff licensing/certification, and USP <797> standards. CSP Pharmaceutical Quality Standards require documentation of preparation methods, adverse reaction reporting, and policies for managing diverse reactions. The guide establishes three contamination risk levels—Low-risk, Medium-risk, and High-risk CSPs—each with progressively stringent environmental controls, personnel training, sterilization verification, and storage requirements. Low-risk CSPs require ISO Class 5 environments with basic quality assurance; Medium-risk requires more rigorous media-fill testing and complex mixing protocols; High-risk demands terminal sterilization verification, bacterial endotoxin testing, and semi-annual media-fill competency evaluations. Additional critical sections address facility design and environmental controls (HEPA filtration, pressure differentials, cleanroom surfaces), personnel training and competency validation (including media-fill testing and gloved fingertip sampling), hazardous drug handling protocols, radiopharmaceutical and allergen extract preparation, storage and beyond-use dating procedures, patient/caregiver training, and adverse event reporting. The guide functions as a compliance assessment tool rather than a solicitation, providing checkboxes for Yes/No responses and includes a vendor information section at conclusion.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| D.3 Past Peformance Contacts.docx | DOCX document | |
| D.1 Summary of Services.xlsx | XLSX spreadsheet | |
| 36C25526R0023_VISN15 Compounding Services_final.pdf |
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Text version
ATTACHMENT 2 (VHA PBM Guidance for Compounded Sterile Products (CSPs)
VHA PBM Assessment Guide for Compounded Sterile Preparations {CSPs) within VAMCs and Outsourced Compounding Pharmacies
Regulatory Requirements
Outsourced Compounding Pharmacy/Facility Yes No VAMC Pharmacy
The pharmacy complies with HIPAA standards □ □ Also required for VAMCs
The pharmacy complies with federal and state EPA □ □ Also required of VAMCs regulations related to disposal and handling of pharmaceutical and hazardous wastes per the RCRA provisions
The pharmacy preparing patient-specific CSPs or □ □ *Also required ofVAMCs if batched CSPs is accredited an accrediting preparing High Risk Level CSPs organization for pharmacy compounding (e.g. PCAB per VHA PBM CSP Guidance.
accredited).
The pharmacy has documented through a Certificate □ □ *Also required ofVAMCs if of Analysis (CoA) or purchase orders of obtaining purchasing APls for compounding active pharmaceutical ingredients (APls) from an purposes.
FDA-and/or DEA-registered pharmaceutical supplier with a Standard Operating Procedures to verify supplier registration status.
The pharmacy has a current active pharmacy license □ □ In cases where the outsourced in good standing from their Board of Pharmacy and compounding pharmacy has a licensed to ship to my state. record(s), finding(s) (i.e. FDA 483 observations), or violation(s) issued by a regulatory body, the
VAMC must evaluate the pharmacy's compliance with corrective action(s) and has satisfactorily addressed violation(s) or finding(s).
The outsourcer meets or exceeds state required □ □ pharmacist-to-pharmacy technician ratios for the state in which the compounding center is located
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 CSPs prepared are documented to meet USP □ □ Also required for VAMCs <797> standards of practice.
The pharmacy has documented having a policy on a □ □ contingency plan in case of an emergency need or request from the VAMC.
Yes No
N/A
N/A
N/A
N/A
I
N/A
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