SB 423, as amended, Bates. Retail nonprescription surplus products: determinations for reuse.
Existing law, the Medical Waste Management Act, administered by the State Department of Public Health, regulates the management, handling, and disposal of medical waste, as defined, including pharmaceutical waste. Existing law also provides for the disposition of hazardous
begin delete waste.end delete A violation of these provisions is a crime.
This bill, until January 1, 2022, would establish criteria to be followed for the handling and management of retail nonprescription pharmaceutical surplus products, as defined, if a reasonable determination for reuse has been made or when a reasonable determination for reuse cannot be made but the product has been recalled as required by law. The bill would authorize the State Department of Public Health to adopt regulations as deemed necessary to establish standards for the proper and safe handling of retail nonprescription pharmaceutical surplus products.
Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
This bill would declare that it is to take effect immediately as an urgency statute.
Vote: 2⁄3. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
Article 11.2 (commencing with Section 25230)
2is added to Chapter 6.5 of Division 20 of the Health and Safety
3Code, to read:
(a) The Legislature finds and declares that this section
8is intended to address the unique circumstances associated with
9the management of retail nonprescription pharmaceutical surplus
10products that potentially can be safely diverted from the waste
11stream for reuse, if appropriate. The Legislature further declares
12that this section shall not be construed to set a precedent applicable
13to the management, including disposal, of other hazardous or
15(b) For purposes of this section, the following definitions shall
17(1) “Retail nonprescription pharmaceutical surplus product”
18means a pharmaceutical, as that term is defined in Section 117747,
19that may be sold without a prescription and that is labeled for use
20by the consumer in accordance with the requirements of the laws
21and rules of this state and the federal government, defined as a
22nonprescription drug in Article 2 (commencing with Section 4015)
23of Chapter 9 of Division 2 of the Business and Professions Code,
24in which a waste generator has made a reasonable determination
P3 1for reuse. A retail nonprescription pharmaceutical surplus product
2does not include waste that is subject to regulation as a hazardous
3waste under the federal Resource Conservation and Recovery Act
4of 1976, as amended (42 U.S.C. Sec. 6901 et seq.).
5(2) “Reasonable determination for reuse” means, upon removal
6of a retail nonprescription pharmaceutical surplus product from
7sale, a generator who has evaluated the product and makes a finding
8that the product meets all of the following criteria:
9(A) The product is in unadulterated packaging.
10(B) The product and packaging are in a condition that is suitable
12(C) The product is not designated for disposal by the
13manufacturer or the manufacturer’s agent.
14(D) The product is otherwise eligible for liquidation or donation.
15(3) “Reverse distributor” or “reverse distribution center” has
16the same meaning as set forth in Section 4040.5 of the Business
17and Professions Code that satisfies all of the following:
18(A) Is licensed as a wholesaler of dangerous drugs by the
19California State Board of Pharmacy pursuant to Section 4160 of
20the Business and Professions Code.
21(B) Is permitted by the
begin delete departmentend delete as a transfer station, if the reverse distributor is located
23within the State of California.
24(C) Is registered with the Department of Toxic Substances
25Control and any other appropriate state and local agencies as a
26hazardous waste generator, transfer facility, or storage facility.
27(D) Complies with handling, storage,
28response, and recordkeeping requirements, and any other applicable
30(c) Notwithstanding Sections 25189.5, 25201, and 117747, if
31a reasonable determination for reuse has been made, a retail
32nonprescription pharmaceutical surplus product may be handled
33in accordance with all of the following:
34(1) The retail nonprescription pharmaceutical surplus product
35shall be transported to a reverse distributor or reverse distribution
36center for any of the following purposes:
37(A) Evaluating the manufacturer’s or supplier’s credit or other
P4 1(D) Transferring back to a manufacturer, distributor, or supplier,
2or its respective agent.
3(2) The retail nonprescription pharmaceutical surplus product
4shall be transported with a tracking document that identifies all of
5the following information:
6(A) The product, the UPC label, and the lot number.
7(B) Name, address, and telephone number of the generator of
9(C) Name, address, and telephone number of the reverse
10distributor or reverse distribution center receiving the shipment.
11(D) The purpose for
which the retail nonprescription
12pharmaceutical surplus product is being shipped to the reverse
13distributor or reverse distribution center.
14(3) Shipments of retail nonprescription pharmaceutical surplus
15products to a reverse distributor or a reverse distribution center
16shall be made via a transporter registered with the United States
17Department of Transportation Federal Motor Carrier Safety
18Administration. Transporters shall use due diligence to ensure safe
19handling, which includes, but is not limited to, ensuring that the
20packaging does not become damaged or adulterated during
21shipment and that the shipment is handled in appropriate moisture
22and temperature conditions.
23(4) The reverse distributor or reverse distribution center shall
24do all of the following:
25(A) Maintain the specified tracking documents for a period of
26three years following receipt date of a shipment and shall make
27those documents available for inspection by any applicable
29(B) Submit a hazardous materials business plan to the
30appropriate state and local agencies, as required by Article 1
31(commencing with Section 25500) of Chapter 6.95 and any
32regulations promulgated by either the
begin delete departmentend delete or any certified unified program agency.
34(d) A retail nonprescription pharmaceutical
surplus product that
35has been transported to a reverse distributor or reverse distribution
36center for any of the purposes listed in paragraph (1) of subdivision
37(c) shall not be stored or held at the reverse distributor or reverse
38distribution center for more than 364 calendar days. A retail
39nonprescription pharmaceutical surplus product held or stored for
40365 or more days shall immediately be considered waste and, if
P5 1hazardous, managed in accordance with applicable federal and
2state hazardous waste management laws and regulations.
3(e) Notwithstanding Sections 25189.5, 25201, and 117747, the
4provisions of subdivision (c) may be used for a retail
5nonprescription pharmaceutical surplus product for which a
6reasonable determination for reuse cannot be made if the product
7has been recalled as required by law, including safety recalls for
begin delete departmentend delete may
10adopt regulations as deemed necessary to establish standards for
11the proper and safe handling of retail nonprescription
12pharmaceutical surplus products.
19 This article shall remain in effect only until January 1, 2022,
20and as of that date is repealed, unless a later enacted statute, that
21is enacted before January 1, 2022, deletes or extends that date.
No reimbursement is required by this act pursuant to
23Section 6 of Article XIII B of the California Constitution because
24the only costs that may be incurred by a local agency or school
25district will be incurred because this act creates a new crime or
26infraction, eliminates a crime or infraction, or changes the penalty
27for a crime or infraction, within the meaning of Section 17556 of
28the Government Code, or changes the definition of a crime within
29the meaning of Section 6 of Article XIII B of the California
This act is an urgency statute necessary for the
32immediate preservation of the public peace, health, or safety within
33the meaning of Article IV of the Constitution and shall go into
34immediate effect. The facts constituting the necessity are:
35In order to make statutory changes needed to address the unique
36circumstances associated with the management, handling, and
37reasonable determination of reuse or retail nonprescription
P6 1pharmaceutical surplus products as soon as possible, it is necessary
2that this act take effect immediately.