California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 9.1 - Prescription Drug Take-Back Services
Section 1776.4 - Drug Take-Back Services in Skilled Nursing Facilities
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
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:
(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.
(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.
(i) The collection receptacle shall contain signage that includes:
(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:
(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.
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