Section 1776.3 - Collection Receptacles in Pharmacies(a) A pharmacy may maintain a collection receptacle for the public to deposit their unwanted prescription drugs for destruction. The pharmacy is responsible for the management and maintenance of the receptacle. The receptacle shall be substantially constructed, with a permanent outer container and a removable inner liner. The collection receptacle shall be locked at all times to prevent access to the inner liner.(b) A pharmacy maintaining a collection receptacle must securely fasten the receptacle to a permanent structure so it cannot be removed. The receptacle shall be installed in an inside location. Except as provided in subsection (c), the receptacle is visible to pharmacy or DEA registrant employees, but not located in or near emergency areas, nor behind the pharmacy's counter.(c) In hospitals/clinics with a pharmacy on the premises, the collection receptacle must be located in an area that is regularly monitored by pharmacy or DEA registrant employees and not in the proximity of any emergency or urgent care areas. When no pharmacy or DEA registrant employees are present, the collection receptacle shall be locked so that drugs may not be deposited into the collection receptacle.(d) The receptacle shall include a small opening that allows deposit of drugs into the inside of the receptacle directly into the inner liner, but does not allow for an individual to reach into the receptacle's contents. During hours when the pharmacy is closed, the collection receptacle shall not be accessible to the public for deposit of drugs. The pharmacy shall lock the deposit opening on the collection receptacle.(e) A pharmacy shall direct consumers to directly deposit drugs into the collection receptacle. A pharmacy shall not accept, count, sort or otherwise handle prescription drugs from consumers.(f) A liner as used in this article shall be made of material that is certified by the manufacturer to meet the 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 or 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 established by the pharmacy or pre-entered onto the liner by the liner's manufacturer or distributor.(g) The liner shall be removable as specified in this section. The receptacle shall allow the public to deposit 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, counted, sorted or otherwise individually handled.(h) 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, without interruption, 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.(i) The liner may be removed from a locked collection receptacle only by or under the supervision of two employees of the pharmacy. Upon removal, the liner shall be immediately, without interruption, sealed and the pharmacy employees shall record, in a log, their participation in the removal of each liner from a collection receptacle. Liners and their rigid containers shall not be opened, x-rayed, analyzed or penetrated at any time by the pharmacy or pharmacy personnel.(j) Liners and their rigid containers that have been filled and removed from a collection receptacle must be stored in a secured, locked location in the pharmacy no longer than 14 days.(k) The pharmacy shall make and keep the records specified in 1776.6.(l) The pharmacy shall ensure the sealed inner liners and their contents are shipped to a reverse distributor's registered location by common or contract carrier (such as UPS, FEDEX or USPS) or by licensed reverse distributor pick-up at the licensed pharmacy's premises.(m) 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.Cal. Code Regs. Tit. 16, § 1776.3
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, 1317.60 and 1317.75, 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).