Cal. Code Regs. Tit. 16, § 1776.4 - Drug Take-Back Services in Skilled Nursing Facilities

A pharmacy may offer drug take-back services in skilled nursing facilities licensed under Health and Safety Code section 1250(c) as authorized by this article.

(a) Skilled nursing facility employees or person lawfully entitled to dispose of the resident decedent's property may dispose of unwanted or unused prescription drugs by using mail back envelopes or packages. The pharmacy shall require skilled nursing facility employees to keep records noting the specific quantity of each prescription drug mailed back, the unique identification number of the mail back package and the preaddressed location to which the mail back envelope is sent.

(b) Only pharmacies and hospitals/clinics with onsite pharmacies may establish collection receptacles in skilled nursing facilities for the collection and ultimate disposal of unwanted prescription drugs. A pharmacy and hospital/clinic with an onsite pharmacy maintaining a collection receptacle in a skilled nursing facility shall:

(1) Be registered and maintain registration with the DEA as a collector.

(2) Notify the board in writing within 30 days of establishing a collection receptacle.

(3) Notify the board in writing within 30 days when they cease to maintain the collection receptacle.

(4) Notify the board in writing within 14 days of any tampering of the collection receptacle or theft of deposited drugs.

(5) Notify the board in writing within 14 days of any tampering, damage or theft of a removed liner.

(6) List all collection receptacles it maintains annually at the time of renewal of the pharmacy license.

(d) Within three business days after the permanent discontinuation of use of a medication by a prescriber, as a result of the resident's transfer to another facility or as a result of death, the skilled nursing facility may place the patient's unneeded prescription drugs into a collection receptacle. Records of such deposit shall be made in the patient's records, with the name and signature of the employee discarding the drugs.

(e) A collection receptacle must be located in a secured area regularly monitored by skilled nursing facility employees.

(f) The collection receptacle shall be securely fastened to a permanent structure so that it cannot be removed. The collection receptacle shall have a small opening that allows deposit of drugs into the inside of the collection receptacle and directly into the inner liner, but does not allow for an individual to reach into the receptacle's contents.

(g) The receptacle shall be securely locked and substantially constructed, with a permanent outer container and a removable inner liner.

(1) The liner shall comply with provisions in this article. The receptacle shall allow deposit of prescription drugs into the receptacle for containment into the inner liner, without permitting access to or removal of prescription drugs already deposited into the collection receptacle and liner. Once a prescription drug or any other item is placed in the collection receptacle, the prescription drug or item cannot be removed, sorted, counted, or otherwise individually handled.

(2) If the liner is not already itself rigid or already inside of a rigid container when it is removed from the collection receptacle, the liner must be immediately placed in a rigid container for storage, handling and transport. A rigid container may be disposable, reusable, or recyclable. Rigid containers shall be leak resistant, have sealable tight-fitting covers, and be kept clean and in good repair.

(h) A liner as used in this article shall be made of material that is certified by the manufacturer to meet American Society for Testing Materials (ASTM) D1709 standard test for impact resistance of 165 grams (drop dart test), and the ASTM D1922 standards for tear resistance of 480 grams in both parallel and perpendicular planes.

(1) The liner shall be waterproof, tamper evident and tear resistant.

(2) The liner shall be opaque to prevent viewing and discourage removal of any contents once the liner has been removed from a collection receptacle. The liner shall be clearly marked to display the maximum contents (for example, in gallons). The liner shall bear a permanent, unique identification number.

(i) The collection receptacle shall contain signage that includes:

(1) The name and phone number of the responsible pharmacy;

(2) Medical sharps and needles (e.g., insulin syringes) shall not be deposited; and

(3) Consumers may deposit prescription drugs including Schedule II-V controlled substances.

(j) Once deposited, the prescription drugs shall not be counted, sorted or otherwise individually handled.

(k) The installation, removal, transfer and storage of inner liners shall be performed only by:

(1) One employee of the authorized collector pharmacy and one supervisory level employee of the long-term care facility (e.g., a charge nurse or supervisor) designated by the authorized collector, or

(2) By or under the supervision of two employees of the authorized collector pharmacy.

(l) Sealed inner liners that are placed in a container may be stored at the skilled nursing facility for up to three business days in a securely locked, substantially constructed cabinet or a securely locked room with controlled access until transfer to a reverse distributor for destruction.

(m) Liners still housed in a rigid container may be delivered to a reverse distributor for destruction by common or contract carrier or by reverse distributor pickup at the skilled nursing facility.

(n) A pharmacy maintaining a collection receptacle in a skilled nursing facility shall make and keep the records as specified in 1776.6.

Notes

Cal. Code Regs. Tit. 16, § 1776.4

1. New section filed 6-6-2017; operative 6-6-2017 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 23).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Section 4005, Business and Professions Code; and Sections 1304.22, 1317.05, 1317.40, 1317.60, 1317.75, 1317.80 and 1317.95, Title 21, Code of Federal Regulations

1. New section filed 6-6-2017; operative 6/6/2017 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 23).