November 3, 2011 

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

**General Questions about the Returns Process**

1. Who initiates the return? Generally the entity seeking credit initiates the return. In a recall or withdrawal situation the manufacturer or manufacturer’s agent will initiate 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? Manufacturers provide return policy to clients as well as to the RD being used

. However, the RD does not know exactly what the healthcare facility will be sending back each time so it does not identify that the credit is available in advance. Most healthcare facilities return un

- needed items on a period ic basis, often without regard to credit. It is more an inventory maintenance issue. T here are some health care facilities that have the R D provide this service and manage credits. 2. Do es the RD have reps that go to healthcare facilities to pull and prepar e pharmaceuticals for shipment to the RD? Many RDs have representatives who will g o to healthcare facilities to perform these functions and prepare returns, but not all. Typically t his is an additional service and will depend on the resources of the heal thcare facility

. If so, does the rep know which items will/will not receive credit? Generally speaking, they will know common items which will receive credit, but there are instances when policies change without the knowledge of the representative or the facility. Occasionally, product line ownership changes will change the credit policy and items that previously received credit may not un der the new owner’s policy or vice versa. 3. Is credit received per container? Manufacturer’s policies vary, but most p rovide credit based on the NDC (Consumer Container, case or shelf pack)

. Per pill if container has been opened? Some manufacturers provide credit for partial containers. This is where there is a large variation in the way policies are established and ap plied. 4. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that have been re

- packaged)? If it is established that items can receive credit, a facility will return pharmaceuticals from any location throughout the healthcare system. However, s ome healthcare facilities have policies which do not allow patient floor pharmaceuticals to be returned to the pharmacy and these facilities may have a different return process

. Are re

packaged pharmaceuticals creditable? Generally not

. 5. Once the shipment arrives at the RD facility, what is the timeframe for processing? RD’s are paid for credit percentage or per item processed , so they are incentivized to process a return quickly. On average returns are processed within 3

- 7 business da ys , but backlo gs in excess of weeks could occur. It will depend on the type and size of the RD

. In the event of a large recall , facilities which are not properly prepared can become overwhelm ed; this would drastically increase the processing time. 6. Are ge neric brands creditable? Again, this will depend on the generic manufacturers ’ return policies

. Damaged shipments are almost always creditable.November 3, 2011

7. Do expired items typically get credit? Yes. Some manufacturer’s policies do not allow for the credit of unexpired pharmaceuticals. Generally manufacturer’s policy does not allow for credit prior to 30, 60, or 90 days in advance of the expiration date. This will vary greatly among manufacturers and types of pharmaceuticals. 8. How is the RD paid for its serv ices? Most RD’s are paid on a percentage of credit received, if they work for the healthcare facility . They may receive payment based on a per item basis if they work for the manufacturer. There are additional fees for onsite services, consulting, tracki ng, destruction , etc

. Does the RD receive a percentage of the credit? Usually the percentage of credit is paid by the healthcare facility or other creditee. Is there a flat fee? Some R Ds working on behalf of the manufacturer tend to have flat fees per se rvice. Services such as p rocessing an NDC, NDC look up, partial container count , damage codes are examples of services for which a flat fee per service is charged. Recall services will vary greatly and may have some flat fee components once the recall i s established such as storage and destruction fees. Generally a flat fee per month is not the only charge. Are there additional charges to the healthcare facility for waste management? Yes, usually there are additional fees depending on the type of mate rial to be managed

. This will also vary greatly if there are controlled substances which need to be managed. 9. Under what circumstances would a healthcare facility return pharmaceuticals to a (forward) distribut or in lieu of sending to a RD? In cases w hen a shipment is damaged or it was not ordered, it would be returned to the forward distributor for credit from the forward distributor. The returns to forward distributors are contractual between the healthcare facility and the forward distributor. Do you p rocess pharmaceuticals from (forward) distributors? Yes. 10. When pharmaceuticals are received at the RD, are they ever shipped to another RD’s facility for crediting? Yes. RD’s working for the healthcare facility on a percentage of credit usually forward returns from their facility to the various RD’s for manufacturers. RD’s working for a manufacturer will forward returns shipped incorrectly or when ownership changes occur. In some instances RDs with multiple facilities will experience a backlog at one fa cility and forward returns to another internal facility that does not have a backlog. 11. Do you accept non

- pharmaceutical products? Yes 12. How long are pharmaceuticals kept on

- si te after providing credit? T his could vary greatly depending on contractual requirements as well as the space restrictions within a facility. Generally, contracts mandate that pharmaceuticals are maintained for 30 days a fter processing

. This allows the manufacturer to audit returns and resolve disputes. The contractual time line can vary and a manufacturer may ask that a particular shipment be kept longer or shorter for a variety of reasons. During recall events pharmaceuticals could be held indefinitel y depending on legal requirements. How long are the pharmaceuticals that become hazardous wastes kept
on - site? Pharmaceuticals that become hazardous waste are kept the average 30 days as previously described. When the manufacturer releases the return t he pharmaceuticals are

“generated ” as waste. The generated hazardous waste pharmaceuticals are kept up to the mandatory maximum of 90 days if the facility is a large quantity generator. Most waste is not stored up to this time. The average time currentl y at our facility is around 45 days from point of generation . Recall materials are kept longer as the manufacturer and /or regulatory agenciesNovember 3, 2011

such as the FDA may not release the pharmaceuticals and require them to be kept as evidence for legal proceedings

. On average how long does it take a pharmaceutical to cycle through your facility? On average 4 5 days for non

- hazardous pharmaceuticals 85 days for hazardous waste pharmaceuticals. The hazardous waste pharmaceuticals are generated much less frequent ly and thus accumulated to transfer to a hazardous waste facility within the 90 day requirement as we are a large quantity hazardous waste generator.

**Shipment**

1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or private hauler ? The size of the return and the client’ s transportation arrangements dictate the shipment method. USPS mail carriers deliver returns, as do common shipping companies such as UPS and Fed

- ex, as well as common carriers such as ABF and Yellow freigh t. It is highly unusual for the creditee to return credits with their own vehicles, however it does happen occasionally and it may depend on size of shipment, security and location

. Is the shipment tracked and is the healthcare facility notified by the RD that the shipment has been received? The RDs request and encourage the shippers to use track able methods and tamper evident devices. However, unless the RD has supplied the shipping method, there is no way for the RD to control that process. Do heal thcare facilities notify the RD that a shipment has been sent? RDs often request notification , but do not always receive it . A Return Authorization Form (RAF) is frequently required , but large shippers are either provided many RAFs or are able to create t heir own. Controlled substances as regulated by the DEA are usually shipped under the specifications under the statute and regulation. Notification is often dependant on the contractual agreements made between the shipper and the RD. 2. Does the board of ph armacy require RDs to keep an inventory of everything received at an RD? Generally speaking yes, however these requirements vary greatly from state to state . All controlled substance s are required to be inventoried. Some Over the Counter medications (OTCs) are required to be inventoried ; again this will depend on the adoption of requirements by states . Stericycle maintains an inventory of all processed items at a minimum for our records

. 3. Are controlled substances shi pped separately from other pharmaceuticals? Depends on the level of the controlled substance. RDs encourage clients to separate the controlled substances, however again this is in the control of the shipper . Schedule I I I, IV, and V are usually shipped t ogether and frequently with non

- scheduled items , however they must be properly identified

. Schedule II’s are generally separated due to the additional requirements for tracking under DEA regulations

. Can you explain more about the process of handling retu rned controlled substances? F irst both the entity in possession of the controlled substance (CS) and the receiver of the CS must be registered with the DEA. As a registrant, there are very specific protocols for tracking, handling, storage and securement of these materials. F or Schedule II CS the shipper must notify the RD in advance. The RD then must create a Form 222 requesting the shipper to send specific quantities of specific NDC’s. The shipper communicates the quantities to the RD inNovember 3, 2011

advance. Th e shipper does not need to ship everything identified on the Form 222 but must identify on the Form 222 what has been shipped. The shipper may not ship any amount in excess of what is identified on the Form 222. If there are excess amounts the RD is requ ired to create another Form 222. Each Form 222 may have up to 10 line items. Each line item is for a specific drug in a specifi c dosage and presentation (NDC s pecific) . One return may have multiple Forms 222 associated with it. Stericycle issues a uniq ue RAF for each Form 222. Each Form 222 must be verified to the item level usually requiring a pill count or liquid measurement for opened containers. For Schedules III, IV, and V a Form 222 is not required. A registrant must track inventory so usually there is an inventory with the shipment either physically or electronically and the inventory will be verified and discrepancies resolved. Non scheduled items are managed in much the same way as credit is requested but not always required by regulation. 4. H ave there been incidences where shipments have been lost or stolen ? This happens but is
rare
. Stericycle has procedures in place to verify shipments and reconcile inventories as part of our best management practices for all shipments we have pre

- inventory for

. CSs have specific requirements and i f necessary a Form 106 will be provide d to the DEA describing missing or lost controlled substances. In the e vent of any kind of diversion full cooperation is provided to law enforcement to prevent further diversion and retrieve any missing pharmaceuticals. Controlled substances are highly desired and security measures are constantly evaluated and tested.

**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? Approximately 5 .5

- 6% Typically, do pharmaceuticals that meet RCRA’s definition of a hazardous waste get credit? Yes. RCRA status has no effect on credit status. Credit status is determined by manufacturer policy which is generally based on expiration date, order quantities, and other factors

. Do you ever manage non

- hazardous pharmaceuticals as RCRA hazardous waste? Occasionally. For items that are hard to dispose of via non

- RCRA incinerators or pose a health risk but are not RCRA, regulated hazardous waste incinerators may be utilized. There may be some circumstances where the manufacturer dictates the final disposal method. 2. Is the manufacturer always contacted prior to dis posal of a creditable pharmaceutical? Yes, based on the contracts Stericycle has with their clients

. Typically, t he credit information is sent to the manufacturer for review prior to disposal. Again, this may vary depending on contract. For materials u nder a recall again it will be dictated by the client therefore those policies will be followed. For a non

- creditable pharmaceutical? If an item is presented for credit but will not receive credit the n the manufacturer is still notified prior to disposal. If an item is sent for disposal only, then there is no notification. The generator may be notified if they present pharmaceuticals for disposal that are otherwise creditable.November 3, 2011

3. What percentage of returned pharmaceuticals is sent back to the manufacturer v ersus being disposed of directly by the RD? This varies greatly and will be dependent on if the material is sent for credit versus recall. Approximately 50% are sent back to the manufacturer or their designee. In the cases where they are shipped to anot her RD then most of the material is ultimately destroyed. It is rare that Stericycle is requested to keep the material when it is anything other than for a recall.