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Title: Section 60-4.5 - Collection Receptacles

Effective Date

03/10/2021

Section 60-4.5. Collection Receptacles

(a) Every collection receptacle maintained at participating pharmacies and residential health care facilities shall comply with all applicable state and federal laws and regulations and:

(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;

(3) Feature an outer container which shall include a small opening that allows contents to be deposited into the inner liner, but which does not allow removal of the inner liner's contents; and

(4) Display signage describing items eligible and not eligible for deposit in the collection receptacle.

(b) Inner liners shall meet the following requirements:

(1) Be accessible only to employees of the pharmacy;

(2) Be waterproof, tamper-evident, and tear-resistant;

(3) Be removable and sealable immediately upon removal without emptying or touching the contents;

(4) The contents of the inner liner shall not be viewable from the outside when sealed;

(5) The size of the inner liner shall be clearly marked on the outside of the liner (e.g., 5-gallon, 10-gallon, etc.);

(6) The inner liner shall bear a permanent, unique identification number that enables the inner liner to be tracked;

(7) Immediately upon removal from the permanent outer container, be sealed by two pharmacy employees, except that in a residential health care facility it may be sealed by one pharmacy employee and one supervisory level New York State-licensed healthcare professional employed by the residential health care facility;

(8) Shall not be opened, x-rayed, analyzed, or otherwise penetrated, and;

(9) If at a pharmacy, be removed from a collection receptacle and retrieved by the reverse distributor or common or contract carrier on the same business day whenever possible.  If not possible, it must be safely secured and stored at the pharmacy until retrieved by the reverse distributor or common or contract carrier; and

(10) If at a residential healthcare facility, be removed from a collection receptacle and retrieved by the reverse distributor or common or contract carrier on the same business day whenever possible.  If not possible, it must be safely secured and stored.  Such storage shall not exceed three business days.

(c) Any pharmacy authorized by DEA to be a collector shall maintain a record that includes the date of sealing, the names of the two employees who performed the sealing, the date of removal, and the unique identification number of the liner.

(d) Pharmacy employees may not handle drugs for disposal, review contents of the collection receptacle, remove, count, weigh, consume, repurpose, restock, redispense, resell, or touch items placed in the collection receptacle.

(e) Installation, removal, transfer, and storage of inner liners must be performed in compliance with all applicable state and federal laws and regulations.

Statutory Authority

Public Health Law, Sections 291 and 3308

Volume

VOLUME A-1a (Title 10)

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