Kristin Fitzgerald 

US Environmental Protection Agency 

Office of Resource Conservation and Recovery 

1200 Pennsylvania Ave., N.W. 

Washington, D.C. 20460 

Mail code: 5304P 

Re: Request for information regarding processing of returned pharmaceutical products 

Dear Ms. Fitzgerald: 

Enclosed is Eli Lilly and Company's (Lilly) response to your questions regarding the 

processing of returned pharmaceutical products. I received your request for information via 

email on December 8, 2011. 

Lilly strongly supports EPA's discussion in the proposed Universal Waste Rule relating to 

"hazardous pharmaceutical products" that pharmaceutical products returned to the 

manufacturer for credit are not "waste." The December 2, 2008 proposed rule recognized that 

in the reverse distribution paradigm where pharmaceuticals are shipped first to a reverse 

distributor where the products remain products until the manufacturer's credit decision is 

made. The preamble language states: 

Because unused or expired pharmaceuticals are being returned (via the reverse 

distributor) for possible manufacturers credit, they still have potential value to the 

pharmacy or hospital and are thus not considered wastes. 

73.Fed. Reg. 73,520, 73,525. 

EPA is correct that unused or expired pharmaceuticals represent a value to our customers. 

Pharmaceutical companies' returns processing areas issue net reimbursements to customers of 

hundreds of millions of dollars each year. 

There are a variety of reasons why pharmaceutical manufacturers provide credit for returned 

products. For controlled substances, each unit dose must be accounted for and the destruction 

witnessed under DEA regulations. Another reason for issuing credits is to prevent diversion 

of medicines. Providing an efficient method for customers to return product helps to ensure 

the safety and security of pharmaceutical supplies, and lessens the risk that medicines will be 

resold on the black market. For example, Lilly is aware that in some countries, drug 

Answers That Matter. 
Lilly is supportive of a "universal waste" category for pharmaceutical wastes that are handled 

outside of the reverse distribution system; managing pharmaceutical wastes that are not 

returned through reverse distribution as universal wastes would make it easier for our patients, 

health care providers, pharmacies, etc. to securely dispose of medicines in a manner that 

prevents diversion of product. 

If you have any questions regarding the information provided, please contact me. 

Sincerely, 

~?~ 

Richard E. Lattimer 

Consultant - HSE 

Global HSE 

Eli Lilly and Company 

(3 17) 276-1204 

Email: r.lattimer@lilly.com 
No. EPA Question Lilly Response 

la. Who initiates the The customer (Health Care Facility or a Wholesaler) initiates the return, 

return? unless it's a product recall. 

lb. Does the RD alert the Lilly publishes a returns policy that outlines what is eligible for credit 

healthcare facility that (htt~ LLwww.lillvtraderelationsanswers.comLPagesLreturn !20iic~ as12x). 

credit is available for Contracts with large wholesalers may also contain provisions regarding 

certain pharmaceuticals crediting returns from the wholesaler. Lilly's customers can review the 

or do health care policy to determine what is eligible for credit. Lilly understands that 

facilities periodically go health care facilities and wholesalers periodically review their inventory 

through inventory to and return items near or beyond the expiration date. 

return un-needed 

items? 

2. Does the RD have reps No, Lilly does not perform this service. 

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? 

3. Is credit received per Yes, credit is issued per original Lilly package and the amount of 

container? Per pill if product remaining. See Lilly's Returns Policy for exceptions. For 

container has been example, if a blister pack originally contained 30 pills, but 5 have been 

opened? taken out of the pack, credit will be issued for the remaining 25, 

assuming the other requirements of the Lilly Returns policy are met. 

4a. Do healthcare facilities We do receive this type of material but, per the Lilly Returns Policy, it is 

return pharmaceuticals not reimbursable. 

from the patient floors 

(e.g., drugs that have 

been re-packaged)? 

4b. Are re-packaged No, see the lilly Returns Policy. 

pharmaceuticals 

creditable? 

5. Once the shipment There are many types of returns from a variety of customers. Each has 

arrives at the RD facility, a different Internal processing time, ranging from 2 to 120 days. 

what is the timeframe 

for processing? 
of the credit? Is there a 

flat fee? Are there 

additional charges to 

the healthcare facility 

for waste management? 

9a. Under what Lilly has no information on this. It does not apply to Lilly. 

circumstances would a 

healthcare facility 

return pharmaceuticals 

to a (forward) 

distributor in lieu of 

sending to a RD? 

9b. Do you process Yes, per the Lilly Returns Policy and individual contracts with the 

pharmaceuticals from wholesalers. 

(forward) distributors? 

10. When pharmaceuticals No, Lilly does not forward materials received to RD facilities. 

are received at the RD, 

are they ever shipped to 

another RD's facility for 

crediting? 

11. Do you accept non- Yes, see Lilly returns policy. Lilly does receive devices used for 

pharmaceutical pharmaceuticals, such as an insulin pens. 

products? 

12a. How long are Generally speaking, the pharmaceutical items that are to be disposed 

pharmaceuticals kept are typically sent to an off-site incinerator within 5-10 days of the 

on-site after providing completion of processing (as described in Question #5). 

credit? 

12b. How long are the Once a determination is made regarding the status of the item, if the 

pharmaceuticals that returned material is determined to meet the definition of 11hazardous 

become hazardous waste", it is managed in accordance with applicable hazardous waste 

wastes kept on-site? rules .. 

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to maintain security over these items. The destruction of these items 

must be witnessed. 

Shipment 

No. EPA Question Lilly Response 

la. Are returned Lilly receives returns via all these types of carriers. 

ph a rmaceutica Is 

shipped to the RD via 

commercial mail carrier 

or USPS or private 

hauler? 

lb. Is the shipment tracked See the Lilly Returns Policy. Lilly provides notification to the customer 

and is the healthcare when a credit determination is made. Because the returns have 

facility notified by the significant financial value to the customer, they will contact Lilly to 

RD that the shipment determine if a shipment has been received and processed. lilly's 

has been received? Returns Policy also recommends that customers insure their shipments, 

due to the significant value of the shipment. 

lc. Do healthcare facilities Generally, health care facilities do not notify us that they are sending a 

notify the RD that a shipment, unless the items are controlled substances. See response to 

shipment has been Question 3a below. 

sent? 

2. Does the board of No, an inventory of everything received is not required of Lilly. Lilly 

pharmacy require RDs only is required to track the inventory of DEA Controlled Substances. 

to keep an inventory of 

everything received at 

an RD? 

3a. Are controlled Schedule 2 Controlled Substances require DEA Form 222 to accompany 

substances shipped the shipment, which mean they typically come in separately as long as 

separately from other they were identified and shipped correctly from the originator. 

pharmaceuticals? Schedule 3-5 Controlled Substances will be sent in with other products. 

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incidences where been received, or was sent to the wrong location. This has not been a 

shipments have been significant issue. Lilly is not aware of any returned items that have 

lost or stolen? been stolen once Lilly has taken possession of the returned products. 

Waste Determination and Management 

No. EPA Question Lilly Response 

la. What percentage of Of the total number of units processed, less than 1% were eventually 

returned determined to be hazardous waste in 2011. 

pharmaceuticals is 

typically RCRA 

hazardous waste once it 

is determined credit will 

or will not be given? 

lb. Typically, do No distinction is made regarding whether a return will be given credit 

pharmaceuticals that based on whether the material will be managed as hazardous waste 

meet RCRA's definition after a credit determination is made. See the lilly Returns Policy for 

of a hazardous waste items that may receive credit. 

get credit? 

lc. Do you ever manage No, but the items received and processed at the Lilly Returns Center 

non-hazardous are currently treated In a hazardous waste incinerator due to an 

pharmaceuticals as existing contract with that facility. Many returns could be managed in a 

RCRA hazardous waste? solid waste incinerator. Returns are managed by incineration to 

decrease the chance of drug diversion, not because of the 

characteristics of the waste. 

2a. Is the manufacturer The customer is advised to follow the Lilly Returns Policy. Lilly (as the 

always contacted prior manufacturer) is not always contacted prior to receiving a returns 

to disposal of a shipment, unless the return is a controlled substance. 

creditable 

pharmaceutical? 

2b. For a non-creditable The customer is advised to follow the Lilly Returns Policy. Lilly (as the 

pharmaceutical? manufacturer) is not always contacted prior to receiving a returns 

shipment. 

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