Compliance

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

The following guidelines have been created to help enhance your basic knowledge of the returns industry and outline what is expected of both customer and returns provider. If you have additional questions or concerns, you may contact PharmaLink at (800)-257-3527 and ask to speak to a member of the PharmaLink Compliance Department.

Frequently Asked Questions

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.

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.

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 “Pharmacy Return” from the toolbar, scroll down the page and click “Download Forms”.  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 a “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 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 cannot 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.

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.

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.

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.

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 Fed-Ex (888)777-6040 for easy pick up of your shipment, their phone number is also supplied to you on the instruction sheet you received with your DEA 222 form package.

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 in advance and informing our controlled substance department of your disposal needs.  The number to call is (800) 257-3527 ext. 266

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.

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 FedEx 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. If this is the case, DEA requires the completion of “DEA Form 106” to document the theft or loss of controlled substances.  Contact PharmaLink for instructions if this occurs.

I used to receive a “DEA 41 Form” with my return paperwork from PharmaLink detailing my drugs and their disposition, why don’t I receive this form any longer?

DEA issued a memo several years ago stating 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

May I ship hazardous materials to PharmaLink?

No, PharmaLink does not handle the disposition of hazardous materials.  However, PharmaLink does maintain a Federal EPA identification number and is registered as a Large Quantity Handler (LQH) of Universal Pharmaceutical Waste by the Department of Environmental Protection (DEP) in Florida.  There is a significant difference between hazardous materials and pharmaceuticals determined to be a hazardous waste by PharmaLink.  Please contact PharmaLink in advance if there is any doubt in whether you should ship a particular product.

Does PharmaLink handle medical, bio-hazardous waste / material?

No, PharmaLink does not have a license to handle these materials.  Please contact your local department of health for directions.

I work in a compounding pharmacy; may I ship my products to PharmaLink for disposal and or return?

Yes. However, please ensure you are familiar with 49 C.F.R. (D.O.T. - Code of Federal Regulations) before shipping anything from a compounding pharmacy. Many of the materials used in the compounding process are considered hazardous before they ever exit your pharmacy and must never be shipped using a common carrier like UPS or Federal Express. Before you ship, please remember that PharmaLink may only accept items for consumer use. As a human you would never ingest or consume items like hydrochloric acid, formaldehyde, or sodium hydroxide; please avoid shipping them to us.

If your pharmacy engages in compounding you are more apt to have items that are prohibited from shipping. Penalties for violation(s) of applicable Federal, State and Local laws regarding improper shipment of hazardous items can be very costly. If you are unsure whether a product is prohibited, please call PharmaLink at 800-257-3527, ext. 267 for assistance. You can also visit www.EPA.gov to access your state's particular laws regarding the shipping of hazardous materials.

As per the EPA and the Florida Department of Environmental Protection (FDEP), PharmaLink is able to receive substances from compounding pharmacies that are pharmaceutical items only. PharmaLink CANNOT receive the following:

• Binding agents, alcohols, bases, acids and non-NDC items
• Known EPA or DOT hazardous materials
• Infectious, medical or bio-hazardous materials / wastes.
• Mixed, combined, or co-mingled raw materials in unfinished dosage forms

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 cannot 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.

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/