Pharmaceutical Repackaging Services for National CMOP (770)

Amendment / Modification

This amendment modifies the solicitation for the following reasons:

• Provides the vendor's Questions and Answers (Q&A) document.

• Includes an updated Performance Work Statement (PWS).

• Includes an updated Pricing Schedule.

• Changes the sample submission address to: Department of Veterans Affairs CMOP Hines ATTN: QA Department 5th & Roosevelt, Building 37 NW Dock 18 Hines, IL 60141

• Performance Work Statement (PWS)

• Pricing Schedule

• Sample Submission Address

• The closing date for receipt of offers has been extended to February 6, 2026, 5:00 PM CST.

Questions & Answers / Clarifications

This document provides vendor questions and government answers regarding Solicitation# 36C77026R0004 for Repacker Services for National CMOP.

• Incumbent: The effort is a follow-on to contract# 36C77020D0001, awarded to Aphena Pharma Solutions.
• Labeling: Labels must meet the requirements stated in the Performance Work Statement (PWS). Offerors should not apply proprietary labels in place of VA-required labels.
• Task Order Structure: Refer to Sections K, L, and M in the PWS for guidance on task order structure.
• Pricing Schedule: Volume and lot discounts are for pricing breakpoints and apply to every individual delivery order, not as a limit on quantity per task order. Reporting duties associated with managing requests will be added to the pricing schedule.
• Bottle/Cap System: The VA/CMOP does not have a designated manufacturer for bottles, caps, and labels. All must be commercially available and meet PWS requirements.
• Testing Data: The Contractor shall supply testing data/certification for cap bottle assembly compliance with CPSC current protocol and standards for child-resistant effectiveness (16 CFR 1700). This does not apply to liter-size bottles.
• Estimated Volumes: Estimated annual usage volumes by cap size and logo type will be provided (refer to #5 in the Q&A).
• SKU and Order Quantity Estimates: Refer to Section P in the PWS for estimated unique oral solid pharmaceutical SKUs, average order quantities per SKU per production batch, and typical order frequency.

This Q&A clarifies requirements and confirms updates to the pricing schedule. Bidders should review the PWS, particularly Sections K, L, M, and P, for detailed information.

Statement of Work (SOW) / Performance Work Statement (PWS)

This Performance Work Statement (PWS) outlines the requirements for pharmaceutical repacking services for the Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) program. The goal is to provide repacked oral, solid pharmaceuticals to improve the efficiency of CMOP operations and ensure faster delivery times to Veterans.

• The Contractor shall serve as a unit-of-use repacker for pharmaceuticals. The VA will purchase pharmaceuticals separately and deliver them to the Contractor for processing.

• The Contractor will receive, validate, repack, and ship pharmaceutical orders as instructed by the Contracting Officer (CO), Contracting Officer’s Representative (COR), or Ordering Officer (OO).

• Repacking will involve various bottle sizes (e.g., 15-count to 360-count) and bulk sizes (e.g., 1-liter to 4-liter).

• The Contractor must comply with all applicable FDA, DEA, EPA, and other Federal, State, and local regulations.

• Government-owned pharmaceuticals must be segregated from non-Government products and CMOP orders must not be co-mingled with other orders.

• The Contractor shall provide bottles, caps, and labels meeting specific characteristics, including child-resistant caps and tamper-evident seals.

• Labels must include specific information, such as drug name, strength, package size, storage conditions, "Manufactured By" and "Packaged By" information, and required barcodes (1D and 2D).

• The Contractor must adhere to Drug Supply Chain Security Act (DSCSA) requirements, including serialization.

• Repacking and delivery are required within ten (10) calendar days of receipt of pharmaceuticals and order instructions.

• The Contractor must provide weekly reports of new NDC’s registered with First Databank or Medi-Span.

• The Contractor shall provide a per-order sales report with each order shipped and billed.

• A Certificate of Destruction must be provided within fourteen (14) calendar days after destruction of retained samples, controls, and excess/damaged product.

• The Contractor is responsible for product damaged while in their possession and must reimburse the ordering CMOP for any Government property spilled, lost, or damaged.

• The PWS applies to the seven (7) CMOP facilities with nine (9) delivery locations, plus a CMOP National Office. The list of facilities may change during the contract term.

• The Contractor must be FDA registered and DEA certified for controlled substances (Class III, IV, V).

• The Contractor must have processes for receiving, inventory control, and DSCSA information recording.

• The Contractor must have a policy for drug testing of employees.

• The Contractor must have a contingency plan for disasters.

• The Contractor must provide office space for Government employees observing Contractor operations.

• The Contractor must have a secure web-based ordering system and provide email notifications for shipments.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet containing pricing schedules and item details for pharmaceutical repackaging services. It outlines various ordering periods, container types, quantities, and associated discounts.

• Action Line Item Information: Details the primary action (Pharmaceutical Repackaging Services) and associated modification numbers.
• Items Sheet: Lists specific line items (CLINs) for pharmaceutical repackaging, including various bottle sizes (e.g., 120cc, 200cc, 1,000cc) and quantities. It also details lot volume discounts, expedite fees, emergency order fees, and monthly reporting services across multiple ordering periods (1 through 5) and a 6-month extension.
• RefData Sheet: Provides definitions for discount types, order types, FOB terms, and state codes.
• UOMRef Sheet: Lists units of measure (UOM) with their corresponding descriptions.
• NAICS/SIC Codes: Lists relevant North American Industry Classification System (NAICS) and Standard Industrial Classification (SIC) codes related to the services provided.
• PROD_SVC_CODE: Lists relevant Product/Service Codes (PSCs).

This pricing schedule is crucial for bidders to understand the specific items, quantities, and pricing structures required for pharmaceutical repackaging services. It details the various ordering periods, potential discounts, and additional service costs, which are essential for preparing an accurate and competitive proposal.