November 21 , 2011, Quality RX Returns Reply



## EPA **Questions and Quality RX Returns Answers**  **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? The customer almost always initiates the return. Most healthcare facilities have a scheduled interval for returning c reditable merchandise. For a hospital with over 1,000 acute ca re beds this can be as frequent as every other week. For a very small hospital with less than 20 acute care beds this can be as in frequent as twice a year. For most hospitals and retailers it is usually on a quarterly basis. As a reverse distributor we use a sales and marketing team to remind customers that it has been 90 days since we last received their return goods. 2. Do es 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? Yes, some clients request this service, which is provided at extra charge. Our field technicians are trained to exclude obvious wastes like repackaged items, patient labeled medications, and other waste s from certain manufacturers that do not issue credit (e.g. American Regent). It is not practical from a time on the road perspective to actually have the field tech perform a full returnable analysis outside of our main facility. 3. Is credit received pe r container? Per pill if container has been opened? This depends on the manufacturer’s published return policy. Some only issue credit for full sealed containers, some for partial containers with certain percentage of content thresholds (e.g. must be at least 50% full to receive any credit). Partial creams, ointments, liquids are not ordinarily returnable. 4. Do healthcare facilities return pharmaceuticals from the patient floors (e.g., drugs that have been re
- packaged)? Are re
- packaged pharmaceuticals creditable? Unless some special billing arrangement has been made between the hospital and/or GPO and the manufacturer, no. 5. Once the shipment arrives at the RD facility, what is the timeframe for processing? QRX will open the box and ‘process’ (sort, count, input data into system, produce a report of returnable status, and generate packing slips) within 10 business days of receipt.November 21 , 2011, Quality RX Returns Reply

6. Are generic brands creditable? Larger manufacturers of generics (Teva, Sandoz) usually issue credit for full sealed c ontainers. Smaller manufacturers (Rugby, Major) frequently do not. 7. Do expired items typically get credit? From a retail environment, 65% of the products are returnable. For a hospital, it is usually less than 50% . More items a hospital returns are from those aforementioned manufacturers that typically do not issue credit, for example on epinephrine syringes on crash carts. A drug store doesn’t carry an item like that. 8. How is the RD paid for its services? Does the RD receive a percentage of the cre dit? Is there a flat fee? Are there additional charges to the healthcare facility for waste management? We paid for a percentage of either the estimated credit or of the actual credit received (customer’s choice). There is sometimes a minimum daily cha rge for onsite service. There may be additional charges for waste disposal and hazardous waste disposal. 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? It depends on the state pedigree laws (in Florida, for example, the hospital cannot do what you explained above over 30 days after receipt). This would happen with a product that was mistakenly over ordered. We do not currently process for any wholesaler forward distributors. 10. When pharmaceuticals are received at the RD, are they ever shipped to another RD’s facility for crediting? Yes, if there is another reverse distributor contracted to process for that manufacturer as part of an outsourcing agreement (like GSK with Stericycle). Other manufacturers process their own returns (like Eli Lilly). 11. Do you accept non
- pharmaceutical products? We do not wish to, but sometimes non
- pharmaceutical products, rangi ng from greeting cards to panty hose to Christmas decorations to OTC PCPs are sent to us.November 21 , 2011, Quality RX Returns Reply

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 lon g does it take a pharmaceutical to cycle through your facility? This depends on the manufacturer’s policy and procedure. If the manufacturer does not require an authorization to return, we usually ship out product within five business days after determ ining it has credit value. If a manufacturer requires a return authorization, and is slow to do so, a product could wait months to be returned. QRX is an EPA CESQG, but adheres to SQG rules in general and returns hazardous wastes every 180 days or less . P
- listed wastes are returned when necessary to keep under the 1 kilo generator threshold. The average product is in our warehouse for 40 days.
**Shipment** 1. Are returned pharmaceuticals shipped to the RD via commercial mail carrier or USPS or private hau ler ? 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 that a shipment has been sent? Common carrier, usually FedEx Ground, hauls QRX product. For very large returns, an LTL truck service is used, as long as the return is palletized. All shipments are tracked using a daily activity report provided by our contracted carrier. Customer Service/Sales personnel notify the customer when the product is re ceived. Smaller customers typically do not inform us ahead of time, and we find out when we check our inbound shipping report from FedEx. One major exception to this is when there are DEA controlled substances involved; all parties are notified in adva nce of shipment, especially for DEA C lass II drugs (e.g. Oxycontin). 2. Does the board of pharmacy require RDs to keep an inventory of everything received at an RD? While not required by the state of Tennessee, we do so anyway at QRX as part of our internal best practice. 3. Are controlled substances shipped separately from other pharmaceuticals? Can you explain more about the process of handling returned controlled substances? Controlled substances fall into two categories for us, C lass II ( e.g. Oxycontin, Cocaine , Fentanyl) and Class III
-V (e.g. Ambien, Xanax, Phentermine). To return CII drugs, a DEA 222 form must accompany the shipment. The customer requests our DEA 222 and we send it to them after verify ing their request along with a separate shippingNovember 21 , 2011, Quality RX Returns Reply

label that has an internal secret code so when the product is received, our receiving clerks know immediately that this is a CII controlled substance and it is locked up in our vault until such time that it is processed. DEA rules require that the returned product and the request match absolutely exactly, so precision is key. The process for CIII
-V is similar but not quite as stringent. For example, there is an inventory form along with a bag to separate the CIII
-V from the rest of the drugs in the box. As soon as the box is open, the inventory form we supplied the customer, along with the drugs in question, are segregated in our DEA approved security cage. 4. Have there b een incidences where shipments have been lost or stolen? Fortunately for QRX, this has never happened to our company. **Waste Determination and Management** 1. What percent age of returned pharmaceuticals is typically RCRA hazardous waste once it is determined c redit will or will not be given? Typically, do pharmaceuticals that meet RCRA’s definition of a hazardous waste get credit? Do you ever manage non
- hazardous pharmaceuticals as RCRA hazardous waste? Approximately 5% of products returned meet some type of RCRA criteria. However, only an item that is deemed non
- returnable will be categorized as RCRA hazardous waste. While it can be defined as off spec or expired, it still holds its original commercial value or a percentage thereof. So the correct way to phrase this is that of the 40% of non
- returnable product, 5% of that is RCRA. Again, in reference to my point above, if it is creditable it is not a ‘waste’. However, we understand the point of the question being asked , and yes, many items like warfarin sodium (P001 when waste) , especially brand name Coumadin from Bristol Myers
-Squibb, and insulin (D009 when waste) from manufacturers like Eli Lilly and Novo Nordisk, do routinely receive credit. However, there are ot her products like nicotine (P075) that are almost all OTC products and are for our purposes never creditable. We do not manage items that do not meet RCRA definitions as hazardous. However, we encourage our customers to ensure the following items are incinerated when waste whenever possible. So while we do not manage non hazardous pharmaceuticals as RCRA because all of our waste is incinerated anyway, we encourage customer we might be using an autoclave or landfill for some of their waste streams t o make sure some non
- RCRA product is incinerated. Not necessarily at a RCRA incinerator, but at an incinerator instead of autoclave or landfill. **ITEMS TO BE INCINERATED** I. **RCRA Acutely Toxic Waste (RCRA INCINERATION)** 

a. COMMON EXAMPLES
- Warfarin Sodium, Nicotine, Physostigmine, PhentermineNovember 21 , 2011, Quality RX Returns Reply II. **Mixed Infectious Hazardous Waste**  **(RCRA INCINERATION)**

a. COMMON EXAMPLES
- Crofab Antivenin, Intron Alfa 2B, Live Vaccines with Thimerosal Preservatives, Abraxane III. **RCRA Hazardous Pharmaceuticals (RCRA INCINERATION)** 

a. COMMON EXAMPLE S (U
- list)
– Lindane, Mitomycin, Daunorubicin, Cyclophosphamide b. COMMON EXAMPLES (D
- list)
– Flexible Collodion, Silver Sulfadiazine, Barium Sulfate, Selenium c. COMMON EXAMPLES (Flammable Gases)
– Epifoam, Protofoam, Granulex, Ethyl Chloride IV. **D.O.T. Non -**  **Flamm able Gases**  require special transport placards and should be segregated for incineration. Non
- Flammable gases may be shipped with flammable gases. a. COMMON EXAMPLES – Ventolin, Maxair, Atrovent V. **E.P.A. Categories of Concern** are products that may not yet be regulated, but we expect regulatory action regarding these items. **a. E.P.A. Classified Greenhouse Gas**  b. COMMON EXAMPLE – Sevoflurane **c. E.P.A. Contaminant Candidate List 3**  d. COMMON EXAMPLE – Estradiol **e. E.P.A. Regulated Pesticide**  f. C OMMON EXAMPLE – Permethrin VI. **Joint Commission Hazardous**
- The Joint Commission, the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) urge hospitals to prioritize safety and health protocols for the most hazardous drugs. This category is a now combined entry of items found in the OSHA Technical Manual, Section VI, Chapter 2 listed drugs, NIOSH “ Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings 2004”, and the NIOSH “List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010” , from the Joint Commission Online, April 13, 2011. 2. Is the manufacturer always contacted prior to disposal of a creditable pha rmaceutical? For a non - creditable pharmaceutical? Yes, we always notify the manufacturer prior to destroying a creditable pharmaceutical; otherwise they might deny us and our customer our credit due. If they have already denied credit either per policy or authorization, our duty to the manufacturer is complete and we destroy without notifying them. 3. What percentage of returned pharmaceuticals is sent back to the manufacturer versus being disposed of directly by the RD? Approximately 60% of our product is returned, and 40% is destroyed. This can vary from return company to return company based on my aforementioned explanation about different customer classes having different amounts of returnable product.