www.lilly.com Phone 317 276 2000 January 31, 2012 Kristin Fitzgerald US Environmental Protection Agency Office of Resource Conservation and Recovery 1200 Pennsylvania Ave.

,N

.W
. Washington,

D

.C. 20460 Mail code

:5304P

Eli Lilly and Company Lilly Corporate Center Indianapolis,

IN 46285 U
.S.A. 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 onDecember

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 arenot "waste." The December
2, 2008 proposed rule recognized that in the reversedistribution paradigm where pharmaceuticals
are shipped first to areverse distributor where the products remain products until the manufacturer's credit decision
is made. The preamble language states: Because unused or expired pharmaceutical

sare being returned (via the reverse distributor) for possible manufacturers credit, they still have potential value to the pharmacy or hospital and arethus not considered wastes. 73.Fed. Reg. 73

,520, 73,525. EPA is correct that unused or expired pharmaceuticals represent

avalue to ourcustomers. Pharmaceutical companies' returns processing areasissue net reimbur

sements to customers of hundreds of millions of dollars each year. There area 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 reasonfor issuing credits is to prevent diversion of medicines

.Providing anefficient 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 onthe black market. For example, Lilly is awarethat in some countries, drug Answers That Matt er.January31,2012 Page2of2 counterfeiterswill buy packaging componentsandevenemptycontainers
sothat theycan moreeasilycounterfeit drugs,orsotheycanrefill packageswithcounterfeitmedicines.The reversedistribution systemalso promotesanadequate supplyofmedicine-ourcustomerscan ordersufficient suppliesandthenreturnthe products
ifnotallthemedicine
isused.Inthis waypatientsarenotfacedwith shortagesofmedicines. Lilly encouragesEPAtoworkwith theFoodand DrugAdministration

toensurethat anymanagementsystemforreturned pharmaceuticalstakesintoaccounttheneedtoensurethe safetyand adequacyof pharmaceutical supplies. Lillyis supportiveofa"universalwaste" categoryfor pharmaceuticalwastesthatarehandled outsideofthereversedistribution system

;managing pharmaceuticalwastesthatarenot returned throughreversedistribution

asuniversalwasteswouldmakeiteasierforourpatients, healthcareproviders, pharmacies,etc

.tosecurely disposeofmedicines
inamannerthat preventsdiversionof product. If youhave anyquestions regardingtheinformation provided, pleasecontactme

. Sincerely

, **~?~** Richard
E.Lattimer Consultant

-HSE GlobalHSE Eli Lillyand Company (3 17)276-1204 Email

:r.lattimer@lilly
.comEPA's Questions for Reverse Distributors Response by Eli Lilly and Company, 1/31/2012 General Questions about the Returns Process No. EPA Question
Lilly Response la. Who initiates the The customer (Health Care Facility ora 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 ordo 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 goto 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?lilly response to EPA Product Returns Questionnaire, 1/31/2012 No. EPA Question
Lilly Response 6. Are generic brands Lilly does not sell generic brands. creditable? 7. Do expired items Yes, for those expired items complying with the Lilly Returns Policy,
a typically get credit? credit will be issued

. 8. How is the RD paid for Lilly charges no fees for returns. Should

a customer utilize an its services? Does the independent reverse distributor (RD), the payment to the RD is strictly RD receive

a percentage between the customer and the RD. 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 aRD? 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 asan insulin pens. products? 12a. How long are Generally speaking, the pharmaceutical items that areto 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 11 hazardous become hazardous waste",
it is managed
in accordance with applicable hazardous waste wastes kept on-site? rules .. Page 2 of 5lilly response to EPA Product Returns Questionnaire, 1/31/2012 No. EPA Question
lilly Response 12c. On average how long

It varies depending onthe type of pharmaceutical and the customer does it take a sending it. See Question #5 for processing times and #12a for shipment pharmaceutical

to cycle preparation time after processing. Therefore, the total cycle time is the through your facility? sumof the times listed in Question #5 and #12a. For aDEA Controlled Substance or Lilly-designated Special Security Substance items

,the cycle time may be longer because those headed for destruction cannot be shipped out unless the off-site incinerator

is scheduled and running 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 anRD? 3a. Are controlled Schedule

2 Controlled Substances require DEA Form 222 to accompany substances shipped the shipment, which mean they typically comein 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. Page 3 of 5lilly response to EPA Product Returns Questionnaire

,1/31/2012 No. EPA Question
Lilly Response 3b. Can you explain more DEA Controlled Substances must be handled in an approved storage about the process of area. Lilly Returns Center personnel identify Controlled Substance handling returned items by the paperwork obtained from the shipper and the container controlled substances? labeling. Once identified, they are stored in a lockbox until they are processed. Only one personin the area processes Controlled Substance items

. 4. Have there been Occasionally,

a customer will call regarding

a shipment that has not 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 onceit is determined credit will orwill 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 (a sthe always contacted prior manufacturer)

is not always contacted prior to receiving

a returns to disposal of a shipment, unless the return

i s a controlled substanc

e. 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. Page 4 of 5Lilly response to EPA Product Returns Questionnaire, 1/31/2012 No. EPA Question
Lilly Response 3. What percentage
of Lilly has no information
on this. It is known that some Reverse returned Distributors will dispose of items directly asa service to their pharmaceuticals

is sent customers

. back to the manufacturer versus being disposed of directly by the RD?
Page 5 of 5