November 3, 2011 

## EPA’s **Questions for Reverse Distributors**

**General Questions about the Returns Process** 1. Who initiates the return? Does the RD alert the healthcare facility that credit is available for certain pharmaceuticals or do health care facilities periodically go through inventory to return un - needed items? Answer: Both. We have two types of service

– On

- Site and Mail

- In. With the On

- Site service we will call the customer every six months and schedule an appointment for one of our reps to go into the pharmacy a nd process product returns. For the Mail

- In, customers simply log onto our website, inventory products, print an inventory list and shipping labels, then ship products to our facility. 2. Do es the RD have reps that go to healthcare facilities to pull and pre pare pharmaceuticals for shipment to the RD? If so, does the rep know which items will/will not receive credit? We have reps that go into pharmacies. They generally know which items will receive credit, but manufacturer policies change constantly so whe n the items arrive at our facility we do a final review to determine which items will be credited and which ones won’t. 3. Is credit received per container? Per pill if container has been opened? Full items are credited per container. For those manufacture rs who accept partial items for credit , some will issue credit on a per

- pill basis while others will simply round to the next lowest quarter. 4. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that have been re

- packaged) ? Are re

- packaged pharmaceuticals creditable? Yes, sometimes we receive items that have been dispensed. No, they are not credit

- worthy. 5. Once the shipment arrives at the RD facility, what is the timeframe for processing? Less than a week. 6. Are generic brands creditable? Generally yes, but it depends on the manufacturer. 7. Do expired items typically get credit? Yes. Typically up to six months or one year past expiration, but again, it depends on the manufacturer. 8. How is the RD paid for its services? Doe s the RD receive a percentage of the credit? Is there a flat fee? Are there additional charges to the healthcare facility for waste management? We receive a percentage of the credit. We do not charge additional fees for waste management. 9. Under what circ umstances would a healthcare facility return pharmaceuticals to a (forward) distributor in lieu of sending to a RD? Do you process pharmaceuticals from (forward) distributors? Many forward distributors (wholesalers) will accept unopened items for full cr edit (no handling fees) within 90 days of purchasing the item so a pharmacy might return product to them in that instance. Once this 90

- day grace period is up, some pharmacies still believe it is better to return product to their wholesaler

– even though the fees are typically higher than those of a reverse distributor. 10. When pharmaceuticals are received at the RD, are they ever shipped to another RD’s facility for crediting? Yes.November 3, 2011

11. Do you accept non

- pharmaceutical products? Yes. Typically HBC items (shampo o, deodorant, toothpaste, etc.) 12. How long are pharmaceuticals kept on

- site after providing credit? How long are the pharmaceuticals that become hazardous wastes kept on

- site? On average how long does it take a pharmaceutical to cycle through your facility ? Returnable products are typically in our facility less than 45 days. Hazardous wastes are here no longer than 90 days.
**Shipment** 1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or private hauler ? Answer: UPS or Fed Ex. Is the shipment tracked and is the healthcare facility notified by the RD that the shipment has been received? Answer: The healthcare facility is not notified by us when a shipment is received. Since we utilize UPS or FedEx shipments are easily tra ceable should the need arise. Do healthcare facilities notify the RD that a shipment has been sent? Answer: No. 2. Does the board of pharmacy require RDs to keep an inventory of everything received at an RD? No. But we keep records for at least two years. 3. Are controlled substances shipped separately from other pharmaceuticals? Can you explain more about the process of handling returned controlled substances? CII products are shipped separately than other items. CIII

- CV products are not segregated for shi pping. Much more documentation is required for our processing of controlled substances. These items are maintained in either a locked cage or a concrete/steel vault while at our facility. 4. Have there been incidences where shipments have been lost or stole n? Answer: Yes. We have had several instances where FedEx employees have pilfered items from our boxes. We have taken additional steps over the years to help reduce this.

**Waste Determination and Management** 1. What percent age of returned pharmaceuticals is typically RCRA hazardous waste once it is determined credit will or will not be given? Answer: About 2% Typically, do pharmaceuticals that meet RCRA’s definition of a hazardous waste get credit? Answer: Yes. Do you ever manage non - hazardous pharm aceuticals as RCRA hazardous waste? Answer: No. 2. Is the manufacturer always contacted prior to disposal of a creditable pharmaceutical? Answer: Yes. For a non

- creditable pharmaceutical? Answer: No. 3. What percentage of returned pharmaceuticals is sent back to the manufacturer versus being disposed of directly by the RD? Answer: About 93.75% of credit

- worthy items processed by us are shipped back to manufacturers or other reverse distributors. The remaining 6.25% are destroyed.