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? Health care facilities (HCFs) typically place their damaged, recalled, expired, or otherwise unwanted

, pharmaceuticals into a box or bin set aside for
the RD’s next visit or for shipping directly to the RD without an onsite visit by the RD

. Visits can be set up as regularly scheduled appointments (i.e. monthly, quarterly, etc.) or as needed based on time or space con s traints at the HCF

. After the return of product
from the HCF to the RD, the RD will evaluate the product for credit eligibility and notify
the HCF

, via online or paper reporting

, of available credits.
2. Does the RD have reps that go to healthcare facilities to pull and prepare pharmaceuticals for shipment to the RD? If so, does the rep know which items will/will not receive
credit? S ervices vary for each R D. EXP ’s procedure includes onsite visits by reps for
documentation of DEA controlled substances prior to shipping

. EXP’s reps do not know which items will receive credit. The evaluation of drug data and decisio ns about credit eligibility take place at our corporate office . Some RDs offer full onsite service s that include making credit and waste determinations at the HCF

. However, it increases the cost of the service event due to the significantly increased time it takes each service representative to review and categorize each pharmaceutical item. In essence, making the waste determinations onsite transfers a large portion of the work conducted at the RD to
the HCF. If required of all service events, it c ould make reverse distribution prohibitively expensive. Also, in many instances EXP is able to obtain credit for items that are deemed waste pursuant to a manufacturer’s policy by calling the manufacturers on behalf of HCF.
3. Is credit received per containe r? Per pill if container has been opened? Credit is based
on criteria f

rom each manufacturer ’s return goods policy (RGP) and is issued on

e stimated or e xact quantities, including partials

. 4. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that
have been re

- packaged)? Are re

- packaged pharmaceuticals creditable? Dispensed

p harmaceuticals from the patient floors are generally no n

- credit able unless the drug has been recalled by the manufacturer. Non

- dispensed, r e

- packaged pharmaceuticals may be
credit eligible , depending on the RGP.
5. Once the shipment arrives at the RD facility, what is the timeframe for processing? The timeframe for processing varies, but may be completed within a couple days.
6. Are generic brands creditable? Yes.
7. Do expired items typically get credit? Yes.
8. How is the RD paid for its services? Does the RD receive a percentage of the credit? Is there a flat fee? Are there additional charges to the healthcare facility for waste management? Yes, y es, and yes. RDs are typically paid a percentage of the anticipated return value (ARV), buy may include flat fees or minimum fees to cover costs for lessvaluable orders. Fees ar e also charged for the disposal of waste generated as a result of

non

- creditable items.
9. Under what circumstances would a healthcare facility return pharmaceuticals to a (forward) distributor in lieu of sending to a RD? Do you process pharmaceuticals from (forward) distributors? HCFs may return product to a forward dist ributor if that forward distributor’s RGP does not allow for the return of product through a RD. EXP does

process product from forward distributors.
10. When pharmaceuticals are received at the RD, are they ever shipped to another RD’s facility for crediting? Yes. Certain manufacturer’s RGPs require pharmaceuticals to be returned to an agent of the manufacturer, which is usually a reverse distributor.
11. Do you accept non

- pharmaceutical products? Yes.

Shipment

1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or private hauler? Is the shipment tracked and is the healthcare facility notified by the RD that the shipment has been received? Do healthcare facilities notify the RD th at a shipment has been sent? S hipments are sent using common carriers (i.e. UPS, FedEx, USPS, etc.) u tilizing barcodes or other means for tracking. Upon request, EXP notif ies
HCF s upon receipt of a shipment. In other instances the HCF s receive notice of receipt
when they receive the processing reports for that shipment. EXP has advance notice that

a shipment is on its way to EXP for all onsite service events ; its representatives have entered information related to the shipment into EXP’s system . In some instances, HCF s notify EXP that a n offsite shipment is on its way to EXP.
2. Are controlled substances shipped separately from other pharmaceuticals? Can you explain more about the process of handling returned controlled substances? Controlled substances are usually shipped with other pharmaceuticals, but are packaged separately.
Controlled substances are documented in accord ance with DEA regulation prior to shipping from the HCF to the RD

. They are placed i n non

- descript boxes and shipped using a carrier that offers tracking

. All shipments are inspected for tampering prior to receipt. Once received at the RD, they are placed into a DEA

- approved security cage (for
CIII

- CV) or vault (for CI & CII). They are then evaluated for credit like other non

controlled substances.
3. Have th ere been incidences where shipments have been lost or stolen? Yes. Incidences of missing product, whether lost or stolen, are investigated by the HCF after the loss is reported to them by the RD.

Waste Determination and Management1. What percentage of returned pharmaceuticals are typically RCRA hazardous wastes once

it is determined credit will or will not be given? Typically, do pharmaceuticals that meet RCRA’s definition of a hazardous waste get credit? Do you ever man age non

- hazardous pharmaceuticals as RCRA hazardous waste? T he percentage of pharmaceutical product received at EXP that is generated as RCRA hazardous waste is less than 2 %

. S ome pharmaceuticals are creditable that would otherwise meet the definition of RCRA
hazardous waste. Non

- hazardous pharmaceuticals may be managed as RCRA hazardous waste, if we feel that is the best method.
2. Is the manufacturer always contacted prior to disposal of a creditable pharmaceutical?
For a non

- creditable pharmaceutical? Disposal of creditable pharmaceuticals is never done without prior approval f rom the crediting entity. Disposal of non

- creditable pharmaceuticals is typically done without prior consent from the manufacturer.