Regulatory

Since its inception the pharmaceutical returns industry has undergone many changes regarding compliance and regulatory issues. While regulations and policies change, one thing remains consistent and that is the PharmaLink commitment to compliance. PharmaLink is dedicated to recognizing the needs of our customers, and strives to be at the apex of understanding the laws of all Federal, State and Local agencies that affect yours and our day to day business.

The following guidelines have been created to help further your knowledge of the returns industry and to outline what is expected of both customer and returns provider. Please click below on the question best suited for your issue. If you have additional questions or concerns, you can contact PharmaLink at 800-257-3527 and ask for the Compliance Department.

• Is it true that I can just throw my drugs into a box and send them to PharmaLink, or is there any preparation involved?
• Does PharmaLink handle controlled substances?
• Do I need to do anything before I send PharmaLink my controlled substances?
• How long is “DEA Form 222” valid?
• May I alter, modify, adjust or cross-out what is described on the “DEA 222 Form” I receive from PharmaLink?
• I’ve used some of the medication that is listed on the “DEA 222 Form” I received from PharmaLink; may I send less than what is described?
• I received a bank style deposit / security bag with my “DEA 222 Form” package. May I use this bag in place of a box to send my controlled substances to PharmaLink?
• May I ship schedule II-V pharmaceuticals, compounds to PharmaLink that do not have NDC #’s?
• I received another “DEA 222 Form” with a PharmaLink “Discrepancy Form” attached after my original narcotic return was processed. What is this and what am I supposed to do?
• It’s been a number of weeks since I’ve sent my controlled substances to PharmaLink; I fear they may have been lost in shipping, what am I to do?
• I used to receive “DEA 41 Forms” with my return paperwork from PharmaLink detailing my drugs and their disposition, why don’t I receive this form any more?
• Can I ship hazardous materials to PharmaLink?
• Does PharmaLink handle medical, bio-hazardous waste / material?
• I work in a compounding pharmacy; may I ship my products to PharmaLink for disposal and or return?
• I have patient blister card medication and patient prescription bottle medication that I wish to return, some contain controlled substances what do I need to do?
• I don’t know how to locate my local field office of DEA, can you help me?
  
  Is it true that I can just throw my drugs into a box and send them to PharmaLink, or is there any preparation involved?
    There is some simple preparation involved before you can send your drugs to PharmaLink.
  - Assure that all drugs that are being shipped are inventoried and include a copy of that inventory with your shipment.
  - Make sure that any loose lids are tightened, as loose lids will spill their container contents during shipping.
  - Choose a sturdy corrugated cardboard box for shipping if you are not a PharmaLink eBudget customer.
  - All liquid and glass containers must be properly wrapped to prevent breakage or leaking during shipping. DOT and FAA may inspect and cite violations for improper shipping.
  - Please be informed as to specialty shipments like controlled substances and hazardous materials outlined on this web page. 
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  Does PharmaLink handle controlled substances?
    Yes, PharmaLink maintains a license from the Drug Enforcement Administration to handle the returns and disposal logistics for schedule 2,3,3N,4,5 pharmaceuticals.
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  Do I need to do anything before I send PharmaLink my controlled substances?
    Yes, before you send PharmaLink any controlled substances please follow these simple instructions.
  - Schedule III-V substances require an inventory to accompany the shipment from your facility to PharmaLink. We invite you to use our customized inventory sheet which is printable from our website at www.Pharmalinkinc.com. Simply choose “Forms” from the toolbar location and select “pharmacy return kit”. Please count all substances accurately to the tab, cap, powder, or liquid measure. PharmaLink suggests retaining the original inventory for your records and including a photocopy with your shipment. You may ship schedule III-V pharmaceuticals combined with legend drugs, however we ask that you segregate them within the box you use for shipping from the main body of your return.
  - Schedule II substances require the usage of “DEA Order Form 222” before they can be shipped to PharmaLink for return or disposal from your pharmacy. DEA has strict laws that forbid the undocumented shipping of class II drugs. To acquire “DEA Form 222” you must complete an inventory of the class II drugs you wish to return before shipping. We have created a form that is printable from the tool bar section of our website to assist you. Once this form has been completed you must fax a copy of the inventory form you created to 727-669-8327 and a “DEA Form 222” will be created on your behalf and mailed to you with the necessary tools for returning to PharmaLink for processing. Incidentally, you can not return schedule II substances combined with legend or schedule III-V substances. Schedule II returns are to be shipped as a completely separate entity. Under normal circumstances the “DEA 222 Form” application process requires 10-14 days. PharmaLink has also created an on line format where the same “CII Return Requests” can be submitted electronically to us thus saving the customer time. This can be performed from our website as well. You may contact PharmaLink for additional information or assistance regarding this service.
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  How long is “DEA Form 222” valid?
    A DEA 222 Form is valid for a period of sixty days from the date created. The issue date is listed on the form. If used outside of sixty days the form is considered void and used in violation of DEA regulations.
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  May I alter, modify, adjust or cross-out what is described on the “DEA 222 Form” I receive from PharmaLink?
    No, if there is an inconsistency on your DEA 222 Form please contact PharmaLink and a replacement will be issued. Please do not void the DEA 222 Form unless told to do so by PharmaLink.
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   I’ve used some of the medication that is listed on the “DEA 222 Form” I received from PharmaLink; may I send less than what is described?
    Yes, however please make sure that you list the lesser amount you are shipping in the packages shipped column of the DEA 222 Form.
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   I received a bank style deposit / security bag with my “DEA 222 Form” package. May I use this bag in place of a box to send my controlled substances to PharmaLink?
    Absolutely not! You stand the chance of your products being destroyed or lost by not using a box for shipping schedule II. Your schedule II substances are to be placed inside of the bag PharmaLink supplies, and the bag placed inside of a box. From there you are to apply the shipping label to the box and retain the tracking number. Please call DHL for easy pick up of your shipment, their phone number is supplied to you on the instruction sheet you received with your DEA 222 form package.
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  May I ship schedule II-V pharmaceuticals, compounds to PharmaLink that do not have NDC #’s?
    DEA does allow for products that were manufactured before NDC numbers were used to identify controlled substances to be destroyed via the use of “DEA Form 222”. This must be done by contacting PharmaLink before hand so that we may assign a generic DEA sponsored NDC code to that product for proper reporting purposes.
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  I received another “DEA 222 Form” with a PharmaLink “Discrepancy Form” attached after my original narcotic return was processed. What is this and what am I supposed to do?
    PharmaLink is required by DEA regulation to document any inconsistencies or errors when we receive narcotic substances from our customers. Many times this may be discovered several days after your original return was processed. When you receive this form you are required to forward the green copy of the form to your local chapter of DEA and retain the brown copy for your records.
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  It’s been a number of weeks since I’ve sent my controlled substances to PharmaLink;   I fear they may have been lost in shipping, what am I to do? 
  PharmaLink narcotic return instructions state that customers are to retain a copy of the shipping/tracking number that is provided as part of the common carriers shipping label before sending their controlled substances for processing. Normally, most lost returns are accounted for using this tracking number. However rare it may be, shipments containing scheduled drugs may become lost in transit. DEA requires the completion of “DEA Form 106” to document the theft or loss of controlled substances. Contact PharmaLink on how to complete this form if this occurs.
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  I used to receive “DEA 41 Forms” with my return paperwork from PharmaLink detailing my drugs and their disposition, why don’t I receive this form any more?
    DEA issued a memo recently stating that they do not wish to use “DEA Form 41” as a means of “transfer of drug ownership”. However, the “DEA Form 41” is still used to document the witnessed destruction of scheduled drugs by DEA registrants.
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  Can I ship hazardous materials to PharmaLink?
    No, PharmaLink does not handle the disposition of hazardous materials from outside sources. However, PharmaLink does maintain an EPA identification number and is registered as a Large Quantity Generator (LQG) of hazardous waste by the Department of Environmental Protection (DEP). This simply means that products are shipped to PharmaLink from pharmaceutical outlets as “credit worthy” according to manufacturers or wholesalers return policies. PharmaLink makes the determination of whether or not a particular product is credit eligible. If the product is deemed “non-credit eligible” only then can the product be considered a “waste”. From there the product is segregated, characterized and profiled according to EPA and DOT classifications regarding hazardous and non-hazardous disposition properties and incinerated.
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  Does PharmaLink handle medical, bio-hazardous waste / material?
    No, PharmaLink does not have a license to handle these materials.
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  I work in a compounding pharmacy; may I ship my products to PharmaLink for disposal and or return?
    Yes, however please make sure that you and your co-workers are familiar with 49 C.F.R. (code of federal regulations) before shipping anything from a compounding pharmacy. Many of the materials used in compounding are considered hazardous before they ever leave your pharmacy and must not be shipped using a common carrier like UPS, DHL or Federal Express. As per the Florida Department of Environmental Protection (FDEP), PharmaLink is able to receive substances from compounding pharmacies that are:
  - Not known EPA or DOT hazardous materials.
  - Not infectious, medical or bio-hazardous materials / wastes.
  -  Not mixed, combined or co-mingled.
  The best course of action is to contact the PharmaLink compliance office in advance to discuss your compounding pharmacy disposal needs.
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  I have patient blister card medication and patient prescription bottle medication that I wish to return, some contain controlled substances what do I need to do?
    Patient blister packs and patient prescription bottles are 100% non-returnable. However, PharmaLink is able to receive these products for destruction purposes only with an attached detailed inventory from the pharmacy. PharmaLink can not accept these items, if an inventory is not present. If these same items contain controlled substances, the same rule applies however the shipper must also be a DEA registrant. Please call PharmaLink if you need additional information regarding this process.
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  I don’t know how to locate my local field office of DEA, can you help me?
    Please click on the DEA Diversion Website link to assist you in locating your local field chapter of DEA. www.deadiversion.usdoj.gov/
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