FAQs

Frequently Asked Questions (FAQs) for Collectors

Whether you are interested in becoming a collector or you are already running a program, we want to be sure to set up your team for success! Below are a few frequently asked questions (FAQs), if you do not see an answer for the issue you have, please call us at (800) 257-3527 and our expert staff will guide you in the right direction.

PharmaLink is a registered Returns Processing facility and we offer various materials and software for Registered Collectors to successfully manage their Collection program. However, it is each Registered Collector’s responsibility to review the DEA regulations on an ongoing basis to ensure that your facility is operating within the perimeters of the program, and to make necessary adjustments.

Click here to view DEA’s Secure and Responsible Disposal Act of 2010.

Can I allow ultimate users and other authorized non-registrant persons in lawful possession of a controlled substance in Schedule II, III, IV, or V to deposit such substances in a collection receptacle at my registered location.

DEA law states:

(c) Collectors shall only allow ultimate users and other authorized non-registrant persons in lawful possession of a controlled substance in Schedule II, III, IV, or V to deposit such substances in a collection receptacle at a registered location. Collectors shall not permit an ultimate user to transfer such substance to any person for any reason. Once a substance has been deposited into a collection receptacle, the substance shall not be counted, sorted, inventoried, or otherwise individually handled.

Is your facility listed as a Collector or Federal, State, tribal, or local law enforcement establishment?

Yes. Awesome! Your facility may maintain a consumer pharmaceutical return kiosk!

DEA regulations state:  (a) Collectors or Federal, State, tribal, or local law enforcement may manage and maintain collection receptacles for disposal.

No. If you are not considered one of these businesses, and would like to have a kiosk in your facility, please contact your local DEA facility to learn how to obtain a kiosk at your location.

Will you permit an ultimate user to transfer such substance (a controlled substance in Schedule II, III, IV, or V) to any person for any reason?

Although it would be difficult to know if the person that is depositing drugs is the actual owner of their possessions DEA law states:

(c) Collectors shall only allow ultimate users and other authorized
non-registrant persons in lawful possession of a controlled substance in
Schedule II, III, IV, or V to deposit such substances in a collection receptacle at a registered location. Collectors shall not permit an ultimate user to transfer such substance to any person for any reason. Once a substance has been deposited into a collection receptacle, the substance shall not be counted, sorted,inventoried, or otherwise individually handled.

Once a substance has been deposited into a collection receptacle, can the substance be counted, sorted, inventoried, or otherwise individually handled?

No.

Collectors shall not permit an ultimate user to transfer such substance to any person for any reason. Once a substance has been deposited into a collection receptacle, the substance shall not be counted, sorted, inventoried, or otherwise individually handled.

What are the rules for placement and maintenance of a collection receptacle(s) ?

(d) Collection receptacles shall be securely placed and maintained:
(1) Inside a collector’s registered location, inside law enforcement’s
physical location, or at an authorized long-term care facility;
(2) At a registered location, located in the immediate proximity of a
designated area where controlled substances are stored and at which an
employee is present (e.g., can be seen from the pharmacy counter). Except as follows:
(i) At a hospital/clinic: A collection receptacle shall be located in an area
regularly monitored by employees, and shall not be located in the proximity of any area where emergency or urgent care is provided;
(ii) At a narcotic treatment program: A collection receptacle shall be located in a room: That does not contain any other controlled substances and is securely locked with controlled access;
(iii) At a long-term care facility: A collection receptacle shall be located in a secured area regularly monitored by long-term care facility employees.

What are the rules for collection receptacles at a narcotic treatment program:?

DEA states: (A collection receptacle shall be located in a room) that does not contain any other controlled substances and is securely locked with controlled access.

What are the design specifications for a collection receptacle?

(1) Be securely fastened to a permanent structure so that it cannot be
removed;
(2) Be a securely locked, substantially constructed container with a permanent outer container and a removable inner liner as specified in § 1317.60 of this chapter;
(3) The outer container shall include a small opening that allows contents to be added to the inner liner, but does not allow removal of the inner liner’s contents;
(4) The outer container shall prominently display a sign indicating
that only Schedule II–V controlled and non-controlled substances, if a collector chooses to comingle substances, are acceptable substances (Schedule I controlled substances, controlled substances that are not lawfully possessed by the ultimate user, and other illicit or dangerous substances are not permitted).

Will your facility be collecting Controlled and non-controlled substances?

(c) Collectors shall only allow ultimate users and other authorized non-registrant persons in lawful possession of a controlled substance in Schedule II, III, IV, or V to deposit such substances in a collection receptacle at a registered location. Collectors shall not permit an ultimate user to transfer such substance to any person for any reason. Once a substance has been deposited into a collection receptacle, the substance shall not be counted, sorted, inventoried, or otherwise individually handled.

Is there a list of Registrants authorized to collect and perform authorized collection activities?

(a) Manufacturers, distributors, reverse distributors, narcotic treatment
programs, hospitals/clinics with an onsite pharmacy, and retail pharmacies that desire to be collectors shall modify their registration to obtain authorization to be a collector in accordance with § 1301.51 of this chapter. Authorization to be a collector is subject to renewal. If a registrant that is authorized to collect ceases activities as a collector,
such registrant shall notify the Administration in accordance with
§ 1301.52(f) of this chapter.

Will your facility be commingling controlled and non-controlled substances?

(b) Only those controlled substances listed in Schedule II, III, IV, or V that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected. Controlled and non-controlled substances may be collected together and be comingled, although comingling is not required.

How many employees must be present to install the Kiosk?

There is no regulation regarding the number of employees that must  be present to install the kiosk.

What are the rules for collection receptacles at a long-term care facility?

A collection receptacle shall be located in a secured area regularly monitored by long-term care facility employees.

Will your facility be collecting Controlled and non-controlled substances?

Yes. (c) Collectors shall only allow ultimate users and other authorized non-registrant persons in lawful possession of a controlled substance in Schedule II, III, IV, or V to deposit such substances in a collection receptacle at a registered location. Collectors shall not permit an ultimate user to transfer such substance to any person for any reason.

How many employees must be present to perform the maintenance of the inner Liner?

(g) The installation and removal of the inner liner of the collection receptacle shall be performed by or under the supervision of at least two employees of the authorized collector.

What are the rules for collection receptacles at a pharmacy?

A collection receptacle be located in the immediate proximity of a designated area where controlled substances are stored and at which an
employee is present (e.g., can be seen from the pharmacy counter).

What are the rules for collection receptacles at a hospital/ clinic?

A collection receptacle shall be located in an area regularly monitored by employees, and shall not be located in the proximity of any area where emergency or urgent care is provided.

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