Reverse_Distribution_Q&A.docx

Reverse Distribution Questions

1. Is this a new opportunity? If not, who is the existing contractor?

There is no previous contract. Previous reverse distribution was done through an agreement with another Federal agency. This is a new opportunity. There is no existing contractor.

1. Are any certifications, licenses or special insurance required to do this project?

Yes, please refer to RFP page 11:

All necessary permits and licenses required by Federal, State, and Local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, permits, and any other requirements for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items or returns. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations.

Article C.5, page 11 The Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation (DOT); U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Department of Defense (DoD) regulations. The Contractor shall also comply with applicable State/Local regulations, and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries

1. What is the dollar value of creditable pharmaceutical products under this program for the past three years?

Please refer to pages 4-5:

The Government estimates that each selected contract awardee will be able to generate a minimum of $2,500 in revenue for their performance of reverse distribution services under any contract resulting from this Statement of Work. Total revenues earned by the contractor will be monitored through the Corporate Dashboard requirement of the Statement of Work. The maximum revenue to be generated from the performance of reverse distribution services by any selected contract awardee resulting from this solicitation shall not exceed $2.5 million for the entire performance period, inclusive of the base year and all four option years.

1. What portion of returned pharmaceutical products was deemed creditable after processing?

That is unknown. However, historically, 30%-50% of pharmaceuticals were returnable for some form of credit.

1. What portion of returnable products is processed On-Site? What is the scope of the On-Site service?

It would be ideal for all pharmaceutical items to be inventoried on-site with the controlled substances, to include the legend medications, and over the counter items.

Please refer to page 9:

The Contractor shall pick up, properly pack and label the medical surgical consumables, biohazards and pharmaceutical products on site to ensure safe transportation by ordinary

Please refer to page 12:

The Contractor shall not separate returnable from non-returnable items on-site; instead the Contractor shall package the designated returns and transport them to the Contractor’s facility where the determination will be made concerning product that is returnable and non-returnable.

Please refer to page 12:

The Contractor shall provide all instructions, forms, labels, and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor's central processing facility. HHS/ASPR will make the determination whether to have a Contractor work on-site to inventory all pharmaceuticals, medical surgical consumables, and/or biohazards and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service, the exception is for schedule II-V controlled substances which will be inventoried and packaged on site for shipment. If on-site service is desired, the Contractor shall provide on-site servicing within a reasonable period of time, preferably within ten business days from the date of the facility request. The Contractor shall not separate returnable from non-returnable items on-site; instead the Contractor shall package the designated returns and transport them to the Contractor’s facility where the determination will be made concerning product that is returnable and non-returnable. However, all controlled substance discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The Contractor shall remove or pick-up controlled substances from the facility by close of business the same day inventory is completed and boxed for return. In addition, the Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. Any and all costs associated with gaining access to a customer facility shall be the responsibility of the Contractor. Within 30 days of receiving the returned goods, the Contractor shall process all designated items by sorting, inventorying, and processing items through either a manufacturer's credit program or through the disposal process in accordance with all applicable Federal, State and Local regulations. Whether the returns are processed using the Contractor’s on-site representative or via off-site processing, the Contractor is responsible for the shipment and associated costs from the facility to the Contractor’s reverse distribution facility.

1. What is the scope of the Off-Site service?

If determined by ASPR that conducting inventory on site is not possible, once returns reach the contractors facility, they will be inventoried and reports provided stating what was received. At this point, the contractor will also make the determination as to what is: returnable, needs to be destroyed, or is to be treated as a biohazard.

Please refer to page 12:

HHS/ASPR will make the determination whether to have a Contractor work on-site to inventory all pharmaceuticals, medical surgical consumables, and/or biohazards and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service…

1. Are any returnable products processed via “box and ship” processing, where HHS handles the packaging and shipment?

If deemed by ASPR to not have the contractor on site, then ASPR will package items for shipping and work with the contractor to arrange for pickup of returns and have them delivered to the contractor’s location. Once returns reach the contractors facility they will be inventoried and reports provided stating what was received. At this point the contractor will also make the determination what is: returnable, needs to be destroyed, or is treated as a biohazard.

Please see page 12:

HHS/ASPR will make the determination whether to have a Contractor work on-site to inventory all pharmaceuticals, medical surgical consumables, and/or biohazards and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service, the exception is for schedule II-V controlled substances which will be inventoried and packaged on site for shipment. If on-site service is desired, the Contractor shall provide on-site servicing within a reasonable period of time, preferably within ten business days from the date of the facility request. The Contractor shall not separate returnable from non-returnable items on-site; instead the Contractor shall package the designated returns and transport them to the Contractor’s facility where the determination will be made concerning product that is returnable and non-returnable.

1. Are the typical returned products in caseload quantities?

As stated in the RFP, ASPR packs caches and kits to fit the needs of their mission assignments. Not all items will be in case pack. Packaging can range from unit dose, to stock bottle, box quantity, or case quantity. ASPR carries a various number of items in different packaging configurations available from different manufacturers.

Please see page 10

· Monthly Reconciliation Reports for each individual account. Reconciliation data shall include but not be limited to NDC, quantity, product name, manufacturer, strength, package size, and form.

1. Will biohazard material be pre-sorted and available for pick-up in separate containers?

Biohazard classification will be dependent upon the contractor’s guidelines. Quantity will dictate how biohazard items need to be packaged and placard.

Additionally, please see page 8:

The resulting contract between Contractor and ASPR allows for pick-up, sorting, and accountability for biohazard, medical surgical and pharmaceutical expired and/or unusable product. At time of pick up product may not be expired but is deemed unusable due to exposure to extreme heat or cold, vermin contamination, or other factors affecting the quality of the products.

1. Who is currently providing this service?

This is a new service.

1. Please clarify that the maximum revenue of $2.5 million specified in Article B.5.1 is only for reverse distribution services, but not a limitation on Waste Disposal fees.

The 2.5 million specified in Article B.5.1. was intended to refer only to reverse distribution services as the Government does not intend to make any additional payments to the contractor beyond the profit that the contractor realizes from performing reverse distribution services. As stated in Section L.3.2. “It is the intention of the Government that all costs associated with the performance of this award be paid from profits the contractor realizes through reverse distribution.” In the event that reverse distribution revenue does not cover all contractor disposal expenses, the Government anticipates those additional expenses will be minimal.

See also page 7:

Revenues are generated from the percentage of fees for processing returns and price per pound fees for disposal services and transportation. Total revenues earned by the contractor will be monitored through the web-based reporting tool requirement of the Statement of Work.