text:
(a) Filter beds and any filtering equipment shall be designed to protect ice from contamination and shall be subject to periodic treatment and cleaning.

(b) All equipment and utensils used in ice production areas shall be of easily cleanable construction, shall be kept clean and in good repair, and shall be handled and stored in a sanitary manner. Materials used as ice contact surfaces shall be smooth, nontoxic, and nonabsorbent. Ice cans shall be leakproof and the inner surfaces of the containers shall be free of corrosion.

(c) Freezing tank covers shall be designed and constructed to protect ice containers from splash, drip, and other contamination, shall be easily cleanable, and shall be kept clean and in good repair. The covers shall be equipped with rings or similar devices when hooks are used for pulling. Can or tank covers, and the ledges or sides of the tank upon which the cover rests, shall be cleaned as often as necessary to keep them in a sanitary condition.

(d) Conveyor surfaces shall be of impervious material and shall protect ice from contaminants that may result from shredding, flaking, peeling, or fragmentation of the conveyor surface.

(e) Equipment lubrication shall not contaminate the ice and only food grade lubricants shall be used.

(f) All product storage and holding areas to be refrigerated shall be cleaned as often as necessary to keep them free of contamination.

(g) Air used for water agitation shall be filtered or otherwise treated to remove dust, dirt, insects, and extraneous material. Filters shall be placed upstream from the compressor and shall be easily removable for cleaning or replacement.

(h) The compressor or blower used to supply air or water agitation shall be designed to deliver oil-free air.

(i) Air lines and core or vacuum devices shall be used as needed to produce ice free of rust or other foreign materials.

article: 10. Ice


kind: section

code: HSC

text: In addition to the requirements of this article, ice shall be considered a food subject to all the sanitation requirements applicable to food generally pursuant to Article 1 (commencing with Section 110425), except those provisions that specifically exclude ice.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

division: 104. ENVIRONMENTAL HEALTH

chapter: 5. Food

article: 10. Ice

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 10. Ice


text:
Any truck, vehicle, or other equipment used for delivery, distribution, or selling ice, shall comply with all of the following:

(a) It shall be constructed and maintained to provide adequate and reasonable protection to the ice transported therein. Care shall be taken to prevent its contact with any contaminants, or other substances that would take the ice out of compliance with the drinking water standards prescribed by this article.

(b) All cubed, crushed, or shaved ice shall be kept in clean receptacles or containers that shall be kept covered while the vehicle is in motion.

part: 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS

article: 10. Ice


text: “Health officer,” as used in this article, means the health officer appointed by a county board of supervisors pursuant to Section 101000, by the governing body of a city pursuant to Section 101460, by the governing body of a city and county, or by a local health district board pursuant to former Section 940, that is continued in effect as to any existing district by Section 3 of Chapter 380 of the Statutes of 1959.

article: 11. Local Enforcement

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 11. Local Enforcement


text: The department, upon the request of a health officer, may authorize the local health department of a city, county, city and county, or local health district to enforce this part, and the regulations adopted pursuant to this part that pertain to retail food establishments, as defined by regulation, if the department determines that the local health department has sufficient personnel with adequate training to do so. The enforcement shall be limited to the area under the jurisdiction of the local health department.

article: 11. Local Enforcement


text: The department may revoke any authorization made pursuant to this article, if it determines, after a hearing conducted pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code that the local health department authorized pursuant to this article is not enforcing this part or the regulations adopted pursuant to this part, or no longer has an adequate staff qualified to do so.

article: 11. Local Enforcement


text: A local health department that is authorized by the department to enforce this part may make inspections, take samples, make laboratory examinations, impose and remove embargoes, hold informal hearings, certify facts to the district attorney, and institute proceedings for the forfeiture, condemnation, and destruction of food found to be adulterated or misbranded. The action shall be instituted in the name of the city, county, city and county, or district of which the local health department is a part, and shall conform to the requirements of this part and the regulations adopted by the department pursuant to this part.

article: 11. Local Enforcement


text: For the purposes of this article, the health officer and his or her deputies shall have the same powers and authority as an inspector of the Bureau of Food and Drug of the department.

article: 11. Local Enforcement


text: When an examination or analysis made pursuant to this part shows that any provision of this chapter has been violated, written notice of that fact together with a copy of the findings shall be furnished to each party from whom the sample was obtained, or who issued the product guarantee.

article: 11. Local Enforcement


text: The health officer shall set a time for an informal hearing, at which the parties may be heard before him or her or his or her representatives. A notice in writing shall be served upon the interested parties at least 15 days prior to the hearing. The informal hearing shall be private and limited to questions of fact. Appearances may be made in person or by attorney. Testimony may be taken and evidence introduced as to the correctness of the findings made by the person making the examination or performing the analysis.

article: 11. Local Enforcement


text: If the examination or analysis is found to be correct, or if any party fails to appear after notice has been duly given, the health officer may certify the facts found to the district attorney of the county. No publication shall be made until after the hearing is concluded.

article: 11. Local Enforcement


text: This article shall not be construed as repealing, either directly or by implication, any of the existing sections of this chapter, but shall be construed as constituting an alternative method of enforcing this part.

article: 11. Local Enforcement


text: This article shall not affect any previous authorization by the department to a local health department of a county, city, or city and county to enforce this part.

article: 11. Local Enforcement


text: The department may adopt regulations relating to the operation of a local health department as it considers necessary to fully effect this article, including, but not limited to, requirements relating to reporting of activities and the numbers and qualification of personnel.

article: 11. Local Enforcement


text:
(a) Any city, county, or city and county may adopt an ordinance that provides for the regulation of the disposition of bullfrogs and turtles imported for sale in live animal markets for use as food. The ordinances may provide for all of the following:

(1) The designation of a local agency to carry out this article.

(2) Require a permit, issued by an agency designated by the city, county, or city and county to issue permits, for the sale of bullfrogs and turtles imported for sale in live animal markets for use as food.

(3) Establish a fee for the permit in an amount determined sufficient to offset the administrative cost of issuing the permit and enforcing the provisions of the ordinance.

(4) Require that animals sold pursuant to the permit be dispatched at the time of sale.

(5) Require that signs be posted at the permittee’s place of business, stating that animals must be properly dispatched and that release into the wild in a live state is unlawful.

(6) Authorize the local agency, after notice and opportunity for a hearing, to suspend or revoke a permit issued pursuant to paragraph (1) for violation of any provision of the ordinance adopted pursuant to this article.

(b) The State Department of Health Services and the Department of Fish and Game may consult with a city, county, or city and county for purposes related to this article.

history: (History: Added by Stats. 2000, Ch. 1062, Sec. 2. Effective January 1, 2001.)

article: 11.5. Local Enforcement: Live Food

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 11.5. Local Enforcement: Live Food


text: Nothing in this article is intended to limit or preempt the jurisdiction of any state agency or commission, or any other state entity, from adopting any regulation or taking any action it deems necessary and appropriate regardless of any local ordinance adopted pursuant to this article.

article: 11.5. Local Enforcement: Live Food


text:
(a) “Bottled water,” means any water that is placed in a sealed container at a water-bottling plant to be used for drinking, culinary, or other purposes involving a likelihood of the water being ingested by humans. Bottled water shall not include water packaged with the approval of the department for use in a public emergency.

(b) “Vended water” means any water that is dispensed by a water-vending machine, retail water facility, or water from a private water source, or other water as defined in Section 111170 that is not placed by a bottler in sealed containers, and that is dispensed by a water-vending machine, retail water facility, water hauler, or any other person or facility for drinking, culinary, or other purposes involving a likelihood of the water being ingested by humans. “Vended water,” does not include water from a public water system that has not undergone additional treatment. Water sold without further treatment is not “vended water” and shall be labeled in accordance with Section 111170.

(c) “Water-bottling plant” means any facility in which bottled water is produced.

(d) A “water-vending machine” means a water-connected vending machine designed to dispense drinking water, or purified or other water products. The machines shall be designed to reduce or remove turbidity, off-tastes, and odors and to provide disinfection treatment. Processes for dissolved solids reduction or removal shall also be used.

(e) “Water hauler,” means any person who hauls water in bulk by any means of transportation if the water is to be used for drinking, culinary, or other purposes involving a likelihood of the water being ingested by humans.

“In bulk,” as used in this subdivision, means containers having capacities of 250 gallons or greater.

(f) “Retail water facility” means any commercial establishment where vended water is sold, and placed in customer’s containers, or placed in containers sold or given to customers who come to the establishment to obtain water.

(g) “Private water source,” means a privately owned source of water, other than a public water system, that is used for bottled or vended water and meets the requirements of an approved source for bottled water as defined in Section 129.3 of Title 21 of the Code of Federal Regulations.

(h) “Bottled water distributor” means any person, other than an employee or representative of a bottled water plant, who delivers bottled water directly to customers.

history: (History: Amended by Stats. 2007, Ch. 575, Sec. 2. Effective January 1, 2008.)

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 12. Bottled, Vended, Hauled, and Processed Water


text:
(a) “Advanced purified demonstration water” means product water from an advanced water purification facility that satisfies both of the following requirements:

(1) The product water is treated by all of the following treatment processes:

(A) Microfiltration, ultrafiltration, or other filtration process that removes particulates before reverse osmosis.

(B) Reverse osmosis.

(C) Advanced oxidation.

(2) The product water meets or exceeds all federal and state drinking water standards and is produced in accordance with the advanced treatment criteria for purified water specified in Section 60320.201 of Title 22 of the California Code of Regulations.

(b) A bottler of advanced purified demonstration water shall do all of the following:

(1) Submit sample labels to the department for review at least 30 days before bottling advanced purified demonstration water.

(2) Submit the analyses of the advanced purified demonstration water required under subdivision (e) of Section 13570 of the Water Code to the department at least seven days before bottling advanced purified demonstration water.

(3) Conduct a full sanitation of the bottling and filling equipment immediately after bottling advanced purified demonstration water.

history: (History: Amended by Stats. 2017, Ch. 561, Sec. 132. (AB 1516) Effective January 1, 2018.)

article: 12. Bottled, Vended, Hauled, and Processed Water


text:
(a) As a condition of licensure, each bottled water plant, which has the same meaning as the definition in subdivision (c) of Section 111070, shall annually prepare a bottled water report and shall, upon request, make that report available to each customer.

(b) The report shall be prepared in English, Spanish, and in the appropriate languages for each non-English-speaking group other than Spanish that exceeds 10 percent of the state’s population.

(c) For purposes of complying with this section, when bottled water comes from a municipal source, the relevant information from the consumer confidence report or water quality report prepared for that year by the public water system pursuant to Section 116470 may be used.

(d) The bottled water report shall include, but not be limited to, all of the following:

(1) The source of the bottled water, consistent with applicable state and federal regulations.

(2) A brief and plainly worded definition of the terms “statement of quality,” “maximum contaminant level,” “primary drinking water standard,” and “public health goal.”

(3) A brief description of the treatment process.

(4) A reference to the United States Food and Drug Administration Internet Web site that provides product recall information.

(5) The bottled water company’s address and telephone number that enables customers to obtain further information concerning contaminants and potential health effects.

(6) Information on the levels of unregulated substances, if any, for which water bottlers are required to monitor pursuant to state or federal law or regulation.

(7) (A) The following statement: “Drinking water, including bottled water, may reasonably be expected to contain at least small amounts of some contaminants. The presence of contaminants does not necessarily indicate that water poses a health risk. More information about contaminants and potential health effects can be obtained by calling the United States Food and Drug Administration, Food and Cosmetic Hotline (1-888-723-3366).”

(B) If the telephone number for the United States Food and Drug Administration, Food and Cosmetic Hotline changes, the statement shall be updated to reflect the new telephone number.

(8) The following statement: “Some persons may be more vulnerable to contaminants in drinking water than the general population. Immuno-compromised persons, including, but not limited to, persons with cancer who are undergoing chemotherapy, persons who have undergone organ transplants, persons with HIV/AIDS or other immune system disorders, some elderly persons, and infants can be particularly at risk from infections. These persons should seek advice about drinking water from their health care providers. The United States Environmental Protection Agency and the federal Centers for Disease Control and Prevention guidelines on appropriate means to lessen the risk of infection by cryptosporidium and other microbial contaminants are available from the Safe Drinking Water Hotline (1-800-426-4791).”

(9) The following statement: “The sources of bottled water include rivers, lakes, streams, ponds, reservoirs, springs, and wells. As water naturally travels over the surface of the land or through the ground, it can pick up naturally occurring substances as well as substances that are present due to animal and human activity.Substances that may be present in the source water include any of the following:(1) Inorganic substances, including, but not limited to, salts and metals, that can be naturally occurring or result from farming, urban stormwater runoff, industrial or domestic wastewater discharges, or oil and gas production.(2) Pesticides and herbicides that may come from a variety of sources, including, but not limited to, agriculture, urban stormwater runoff, and residential uses.(3) Organic substances that are byproducts of industrial processes and petroleum production and can also come from gas stations, urban stormwater runoff, agricultural application, and septic systems.(4) Microbial organisms that may come from wildlife, agricultural livestock operations, sewage treatment plants, and septic systems.(5) Substances with radioactive properties that can be naturally occurring or be the result of oil and gas production and mining activities.”

(10) The following statement:

“In order to ensure that bottled water is safe to drink, the United States Food and Drug Administration and the State Department of Public Health prescribe regulations that limit the amount of certain contaminants in water provided by bottled water companies.”

(11) (A) The following statement, if nitrate (NO3) levels above 23 ppm but below 45 ppm (the maximum contaminant level for nitrate (NO3)) are detected: “Nitrate in drinking water at levels above 45 mg/L is a health risk for infants of less than six months of age. These nitrate levels in drinking water can interfere with the capacity of the infant’s blood to carry oxygen, resulting in a serious illness. Symptoms include shortness of breath and blueness of the skin. Nitrate levels above 45 mg/L may also affect the ability of the blood to carry oxygen in other individuals, including, but not limited to, pregnant women and those with certain specific enzyme deficiencies. If you are caring for an infant, or you are pregnant, you should ask advice from your health care provider.”

(B) If the nitrate disclosure requirements for municipal water suppliers are revised by the State Department of Public Health, this statement shall be updated to reflect the revision.

(12) (A) The following statement, if arsenic levels above 5 ppb, but below 10 ppb (the maximum contaminant level for arsenic), are detected: “Arsenic levels above 5 ppb and up to 10 ppb are present in your drinking water. While your drinking water meets the current EPA standard for arsenic, it does contain low levels of arsenic. The standard balances the current understanding of arsenic’s possible health effects against the costs of removing arsenic from drinking water. The State Department of Public Health continues to research the health effects of low levels of arsenic, which is a mineral known to cause cancer in humans at high concentrations and is linked to other health effects, including, but not limited to, skin damage and circulatory problems.”

(B) If the arsenic disclosure requirements for municipal water suppliers are revised by the State Department of Public Health, this statement shall be updated to reflect the revision.

(13) A full disclosure of any exemption or variance that has been granted to the bottler by the State Department of Public Health, including an explanation of reasons for each exemption or variance and the date of the exemption or variance.

history: (History: Amended by Stats. 2008, Ch. 179, Sec. 155. Effective January 1, 2009.)


text:
(a) Any person who processes, packages, distributes, transfers, or stores bottled water or vended water shall comply with the good manufacturing practices described in Part 129 of Title 21 of the Code of Federal Regulations.

(b) Prior to bottling or vending water, the water shall be subjected to filtration and effective germicidal treatment by ozone, ultraviolet, carbon dioxide, or an equivalent disinfection process approved by the department, except that the requirements for filtration and germicidal treatment shall not apply to mineral water as defined in and from a source that is subject to the council directive of the European Economic Community pertaining to natural mineral waters, dated July 15, 1980, or that is subject to any other natural mineral water standard in the country of origin that prohibits filtration and germicidal treatment, so long as both of the following conditions are met:

(1) The source and product are certified by the responsible authority in the country of origin as complying with microbiological standards at least equal to the standards of this article.

(2) The product complies with microbiological standards of this article.

(c) Bottled or vended water that originates from a surface water source that is not protected from surface contamination shall be subjected to ozonation, filtration, or another effective process that removes or destroys the cysts of the parasite Giardia lamblia. For the purposes of this section, a spring house, catchment basin, storage tank, or bore hole adjacent to a natural spring water source as defined in paragraphs (3) and (8) of subdivision (e) of Section 111170, is not a surface water source.

(d) Ollas or other water-holding dispensers, both refrigerated and nonrefrigerated, water-vending machines, and water dispensers in retail water facilities, shall be examined for cleanliness each time they are serviced by the distributor, bottler, retail water facility, or water-vending machine operator. When necessary, these dispensers shall be sanitized according to the methods described in Part 129 of Title 21 of the Code of Federal Regulations.

(e) Sanitary operations, equipment procedures, and process controls used in the treatment, storage, transport, or dispensing of water at a retail water facility shall comply with the good manufacturing practices described in the following provisions of Part 129 of Title 21 of the Code of Federal Regulations: subdivisions (a) to (c), inclusive, of Section 129.37; Section 129.40; and subdivisions (a), (c), (d), and (h) of Section 129.80.

(f) Sanitary operations, equipment, procedures, and process controls used in the treatment, storage, transfer, transport, or dispensing of water by water haulers, shall comply with the good manufacturing practices described in the following provisions of Part 129 of Title 21 of the Code of Federal Regulations: subdivisions (a) and (b) of Section 129.37; Section 129.40; and subdivisions (a), (c), (d), and (h) of Section 129.89.

(g) The design and construction of wells, bore holes, catchment basins, spring houses, storage tanks, or other water-contact equipment used by private water sources shall comply with the requirements of the local regulatory authority. Sanitary operations, equipment procedures, and transfer controls used in the treatment, storage, transfer, or dispensing of water by private water source operators shall comply with the good manufacturing practices described in the following provisions of Part 129 of Title 21 of the Code of Federal Regulations: subdivision (a) of Section 129.37; Section 129.40; and subdivisions (a), (c), (d), (g), and (h) of Section 129.80.

(h) Bottled water may be processed through lines used also for other food products under the following conditions:

(1) Process lines, including storage tanks and associated equipment, shall be used exclusively for the production of bottled water, except for filling equipment, that may be used also for filling other food products.

(2) Before being used for the bottling of water, filling equipment that is designed to be cleaned in-place and that is used for filling other food products shall be thoroughly cleansed and sanitized in-place in accordance with the manufacturer’s specifications and in compliance with Section 129.80 of Title 21 of the Code of Federal Regulations and the supplementary procedures that follow in paragraphs (3) to (7), inclusive, of this section.

(3) Immediately following completion of filling operations for any other food product other than water, the filler shall be thoroughly rinsed internally and externally with potable water.

(4) In accordance with filler manufacturer’s instructions, any parts that are not designed to be cleaned in-place shall be disassembled and removed. All of these parts shall be cleansed and sanitized prior to reassembly using appropriate cleansing and sanitizing procedures, as specified in subdivisions (c) and (d) of Section 129.80 of Title 21 of the Code of Federal Regulations.

(5) All surfaces of the filler that do not contact food products shall be cleaned manually so as to render all surfaces clean and free of any residues.

(6) The filler shall be prepared and all appropriate connections made in accordance with the filler manufacturer’s instructions to place the filler in the clean-in-place mode. The following procedures shall be followed:

(A) An alkaline cleaning solution of appropriate strength shall be recirculated through the filler to provide effective cleaning of all product contact surfaces, with a minimum recirculation time of 20 minutes at a temperature between 140 and 170 degrees Fahrenheit.

(B) The cleaning solution shall be drained and followed with a potable water rinse-to-drain for the removal of all residual cleaner alkalinity. This step may be supplemented by the application of an acidified rinse prior to the potable water rinse in order to neutralize any residual alkalinity on product contact surfaces.

(7) Following reassembly of all parts to place the filler into the product mode and just prior to bottling water, the filler shall be sanitized in-place in accordance with procedures specified in subdivision (d) of Section 129.80 of Title 21 of the Code of Federal Regulations.

(8) Any alternate cleaning, rinsing, or sanitizing operations or processes not described in this section shall be approved in writing by the department.

(i) Bottled water and bulk waters sold at retail shall not contact equipment, lines, tanks, or vehicles used for processing, packaging, holding, or hauling of any nonfood product.


text:
The quality and labeling standards requirements for bottled water and vended water, including mineral water, shall include all standards prescribed by Section 165.110 of Title 21 of the Code of Federal Regulations. In addition, bottled water and vended water, when bottled, shall comply with the following quality standards and any additional quality standards adopted by regulation that the department determines are reasonably necessary to protect the public health:

(a) Bottled water and vended water shall meet all maximum contaminant levels set for public drinking water that the department determines are necessary or appropriate so that bottled water may present no adverse effect on public health. New or revised allowable levels or monitoring provisions adopted for bottled water by the United States Food and Drug Administration under the federal Food, Drug and Cosmetic Act that are more stringent than the state requirements for bottled water are incorporated into this chapter and are effective on the date established by the federal provisions unless otherwise established by regulations of the department.

(b) Bottled and vended water shall not exceed 10 parts per billion of total trihalomethanes or five parts per billion of lead unless the department establishes a lower level by regulation.

(c) Bottled and vended water shall contain no chemicals in concentrations that the United States Food and Drug Administration or the state department has determined may have an adverse effect on public health.

history: (History: Amended by Stats. 2006, Ch. 538, Sec. 425. Effective January 1, 2007.)


text: Polycarbonate resins manufactured after January 1, 1988, and intended for use in fabricating containers for water products defined in this article shall not contain in excess of three parts per million residual methylene chloride or in excess of 200 parts per million residual monochlorobenzene unless the department establishes a lower level by regulation. For the purpose of monitoring compliance with this section, the concentration of methylene chloride and monochlorobenzene shall not exceed one part per billion in water. “Polycarbonate resins” means the substances defined by Section 177.1580 of Title 21 of the Code of Federal Regulations except as modified by this section.


text:
Any owner or operator of a water-vending machine or other device from which any operator or customer dispenses vended water shall comply with the following standards of design, construction and sanitation and any additional standards adopted by regulation that the department determines are reasonably necessary to protect the public health. The water-vending machines or devices shall do all of the following:

(a) Comply with the construction and performance standards established by the department or by an independent authority approved by the department.

(b) Be designed and constructed to permit easy cleaning and maintenance of all exterior and interior surfaces.

(c) Have all parts and surfaces that come into contact with the water constructed of approved, corrosive-resistant and nonabsorbent material capable of withstanding repeated cleaning and sanitizing treatment.

(d) Have a recessed or guarded corrosion-resistant dispensing spout.

(e) Be designed so that all treatment of the vended water by distillation, ion exchange, filtration, ultraviolet light, reverse osmosis, mineral addition, or any other acceptable process is done in an effective manner.

(f) Have an effective system of handling drip, spillage, and overflow of water.

(g) Have a backflow prevention device approved by the department for all connections with the water supply.

(h) Dispense water disinfected by ultraviolet light or other method approved by the department prior to delivery into the customer’s container.

(i) Be equipped with monitoring devices designed to shutdown operation of the machine when the disinfection unit fails to function, or shall be monitored daily at startup and manually shutdown whenever the unit fails to function.

(j) Be equipped with a self-closing, tight-fitting door on the vending compartment, or enclosing the vending spout to protect the vending spout when the water-vending machine is not in use. As an alternative, water-vending machines or other water-dispensing devices may be enclosed in a room with tight-fitting walls, ceilings, and one of the following: a self-closing door, an effective air screen device, or an alternative effective device approved by the department.

(k) Comply with the American Water Works Association (AWWA) specifications for granular activated carbon if used in the treatment of potable water (AWWA B604-74).

( l) Be maintained in a clean and sanitary condition, free from dirt and vermin.

(m) Use a state approved and regulated public water supply or private water source.

(n) Be located in an area that can be maintained in a clean condition and in a manner that avoids insect and rodent harborage.

(o) Be equipped with monitoring devices designed to shut down the labeled purified water delivery system if treatment of water by the machine does not result in a total dissolved solids content of less than 10 milligrams per liter in the purified water. Alternatively, machines shall be monitored daily at startup and manually shutdown whenever the total dissolved solids content exceeds 10 milligrams per liter in the purified water.


text: It shall be unlawful to operate a bottled plant water plant, water-vending machine, retail water facility, or private water source in violation of the minimum health standards of this article.


text: It is unlawful for any person to operate a water vending machine in this state that does not satisfy the minimum standards prescribed by this article for the design, construction, and sanitation of water-vending machines.


text: The department, upon the request of a local health officer, may authorize the local health officer to implement and enforce those provisions of this article that relate to water-vending machines, retail water facilities, and water haulers under the terms and conditions specified by the department.


text: No water-vending machine shall be used in this state that does not at least satisfy the minimum standards adopted by the department.


text:
(a) Each water-vending machine, retail water treatment plant, water hauler vehicle and facility, and private water source shall be maintained in a clean and sanitary condition at all times.

(b) (1) The department shall require that water-vending machines be cleaned, serviced, and sanitized in accordance with the manufacturer’s specifications, but at least once every 31 days.

(2) Inspection records shall be kept for every visit made by either the operator or the maintenance personnel pursuant to this subdivision. These records shall show the date and time of the visit, any tests performed, any maintenance performed, and the signature or electronic signature of the operator or maintenance personnel. The records shall be kept by the owner of the water-vending machine for a minimum of two years and shall be made available to the department upon request.

(c) A record of any consumer complaints shall be kept on file with the owner of the water-vending machine for a minimum of two years, and shall be made available to the department upon request.

(d) If the department determines that there is a violation of this article, the department may do either or both of the following:

(1) Embargo the machine pursuant to Section 111860.

(2) Impose a fine, as determined appropriate by the department.

(e) (1) The department shall, annually, conduct inspections of not less than 20 percent of the licensed water-vending machines in the state and shall include both rural and urban counties. The selection of these machines shall be dependent on the state of the machine and the quality of the water source, and any other factors as determined by the department.

(2) The department may perform, within 12 months of the initial violation, one or more reinspections of each water-vending machine or water retailer that is found to be in violation of this section as necessary to prevent repeated or continuing violations. The department shall charge a fee to the owner to cover the costs of performing the reinspections. The fee shall not exceed the full cost of performing the reinspections up to a maximum of one hundred dollars ($100) per hour.

(f) Subdivisions (b) to (e), inclusive, shall become operative January 1, 2009.

history: (History: Amended by Stats. 2007, Ch. 575, Sec. 4. Effective January 1, 2008. Subds. (b) to (e) are operative January 1, 2009, by subd. (f).)


text:
(a) No person shall operate a water-bottling plant, a private water source, or be a bottled water distributor in this state except pursuant to a license issued by the department. If a person has a valid water-bottling plant license issued by the department, additional license fees for a private water source operator, a retail water facility, a water hauler, or a bottled water distributor based and operating at the same address, shall not be required.

(b) No person shall own or operate a water-vending machine or a retail water facility or be a water hauler, except pursuant to a license issued by the department or to a permit issued by a local health department.

(c) It shall be unlawful for any person to bottle, collect, treat, hold, distribute, haul, vend, or sell bottled water, vended water, operate a retail water facility, or operate a private water source without the license as required by this article. Any bottled water or vended water dispensed by a retail water facility or a private water source that is not licensed in compliance with this article is misbranded and may be embargoed pursuant to subdivision (e) of Section 111120.

(d) It shall be unlawful for a water bottler, distributor, vendor, retail water facility operator, or private water source operator to sell or otherwise distribute water that is adulterated, as defined in Section 110445, 110545, 110560, or 110565, or that is misbranded as defined in Article 6 (commencing with Section 110660) of Chapter 5.

(e) For the purposes of enforcing this section, water may be embargoed pursuant to Section 111860 in its immediate container, well, spring, spring vault, holding tank, water hauling vehicle, retail water treatment system, spigot, or pipe if there is reasonable cause to believe that it is adulterated.

(f) Any retail water facility, water vendor, or water hauler that violates this article may be subjected to the same penalty and enforcement procedure provided for violation of this article by a water bottling facility.


text: No bottled water produced in an out-of-state bottling plant shall be sold or distributed within this state unless either the out-of-state bottler or the distributor shall have first obtained a bottler’s or distributor’s license.


text:
(a) The department shall charge and collect a fee for each license application submitted in accordance with the fee schedule in Table 1, that shall be an amount reasonably necessary to produce sufficient revenue to enforce this article. The fees collected shall be adjusted annually as required by Section 100425. New applicants for a water bottling plant license shall pay Category 2 fees for the first license year.

(b) The water-bottling plant and bottled water distributor categories shall be determined by dividing by 52 the number of gallons produced or shipped into California during the previous year. If the result is an average of 5,000 gallons or less per week, the firm is Category 1. If the average exceeds 5,000 gallons per week, the firm is Category 2.Table 1 License FeesLicense ClassAnnual FeeWater-Bottling Plant Category 1 $310Category 2 875Water-Vending Machine 40Water Hauler 310Retail Water Facility 310Private Water Source Operator 310Bottled Water Distributor 310(c) The owners or operators of each water-bottling plant, retail water facility, private water source, each water hauler in California and bottlers or distributors of water bottled out-of-state shall make application for a license on forms provided by the department. Applications and license fees shall be submitted annually. Applicants shall provide to the department, in electronic format, the serial number of each machine, and the street address, city, ZIP Code, and county where the machine is located.

(d) Each water-vending machine owner or operator shall make application annually for a license for all machines on forms provided by the department. A decal or seal provided by the department indicating a license fee has been paid shall be affixed in a prominent place to each water-vending machine in service. The duty to display the decal or seal shall apply only on and after the decal has been received by the operator.

history: (History: Amended by Stats. 2007, Ch. 575, Sec. 5. Effective January 1, 2008.)


text:
The department may deny any license application or revoke or suspend any license issued for cause. The department shall inform the person of any denial, revocation, or suspension in writing, stating with particularity reasons for the denial, revocation, or suspension.

“Cause,” as used in this section, means a violation of any provision of this chapter or any regulation adopted pursuant thereto.


text: The department shall charge and collect a fee for each department evaluation required to issue a new license for a water-vending machine model or a retail water facility to determine compliance with standards established by this article. The fee shall be three hundred dollars ($300) and shall be adjusted annually as required by Section 100425.


text:
(a) The department shall require each bottler, distributor, or vendor of bottled water, each owner or operator of any water-vending machine, each water hauler, each retail water facility operator, each private water source operator, and each applicant for a license, to test for all substances necessary to establish conformance to standards adopted pursuant to Section 111080 at the times and frequencies the department may reasonably establish.

(b) Each product dispensed by a water-vending machine or a retail water facility shall be sampled and analyzed for coliform bacteria at least once every six months. The analysis shall be submitted to the department indicating whether the water is pure and wholesome. Analysis of vended water or water from retail water facilities shall be submitted to the local health officers if the local health officers are authorized by the department pursuant to subdivision (b) of Section 111105.

(c) Purified waters from retail water facilities shall be analyzed by the operator for dissolved solids by conductivity measurement not less frequently than once every seven days.

(d) Purified water from vending machines shall be analyzed by the operator for the dissolved solids by conductivity measurement each time the vending machine is serviced.


text:
(a) All sources of bottled water, vended water, and water dispensed by a retail water facility shall be monitored annually for the presence of volatile organic compounds of potential public health concern, as specified by the United States Environmental Protection Agency in Tables 2 and 14 contained in Volume 50 of the Federal Register on pages 46904, 46923, and 46924 on November 13, 1985, or as reasonably specified by the department as a condition of licensure.

(b) In lieu of source water monitoring required by this section, a water bottler, water vendor, or a retail water facility may document that the source monitoring required by this section is conducted by another entity approved by the department, or may comply with the treatment requirements of subdivision (c).

(c) Detection in the source water of a volatile organic compound, except trihalomethanes, for which source monitoring is required pursuant to this section shall be followed immediately by a program of periodic monitoring by the water bottler, water vendor, or retail water facility to confirm the presence or absence in the source water of the volatile organic compound. If the volatile organic compound is confirmed to be present in the source water it shall be treated using granular activated carbon treatment or an equivalent treatment operated in accordance with good manufacturing practices as provided in Section 129.80 of Title 21 of the Code of Federal Regulations until the time that the concentration of the volatile organic compound does not exceed either one part per billion, or any United States Environmental Protection Agency or United States Food and Drug Administration level for drinking water, or a maximum contaminant level established by the department for bottled water.

(d) The department may exempt any water bottler, water vendor, or retail water facility from the monitoring requirements of this section for any source based on a showing satisfactory to the department that the source (1) does not contain the volatile organic compound for which monitoring is required and (2) is not vulnerable to contamination by the volatile organic compound because for surface water sources the compounds are not applied, manufactured, stored, disposed or shipped upstream, and for groundwater sources, the compounds are not applied, manufactured, stored, disposed, or shipped in the groundwater recharge basin.


text: Notwithstanding any other provisions of this article, the department may require any bottler, distributor, or vendor of bottled water, any owner or operator of a water-vending machine, any water hauler, any retail water facility operator, any private water source operator, or any applicant for a license to test and submit results to the department for any substance, including organic chemical contaminants, at any time that the department believes the substance may be present in the water source and threaten the public health.


text:
(a) Upon a determination by the department that a particular water source is subject to potential contamination, the department shall notify the bottler, distributor, or vendor of bottled water, the owner and operator of any water-vending machine, any water hauler, any retail water facility operator, or any private water source operator of the specific contaminants or class of contaminants that pose a potential health risk.

(b) Within 90 days after notification by the department, the bottler, distributor, vendor of bottled water, the owner and operator of any water-vending machine, any water hauler, any retail water facility operator, or any private water source operator shall conduct an analysis of the water source and submit the results of the analysis to the department.

(c) If evidence of contamination is found, the department may, by order, require the bottler, distributor, vendor of bottled water, or the owner and operator of any water-vending machine, any water hauler, any retail water facility operator, or any private water source operator to conduct a source and product water analysis for the contaminants of concern in accordance with conditions specified by the department. The water analysis shall be conducted and reported on an annual basis, unless the department finds that reasonable action requires either more frequent or less frequent analysis.

(d) The department may, by order, require the bottler, distributor, vendor of bottled water, the owner and operator of any water-vending machine, any water hauler, any retail water facility operator, or any private water source operator to reduce or eliminate the concentration of any chemical that the department determines may have an adverse effect on public health. Until an enforceable standard has been established for a chemical that may have an adverse effect on human health, the department may require treatment techniques to reduce the concentration of the contaminants that require treatment, in the department’s judgment, to prevent known or anticipated adverse effects on the health of persons. The treatment system shall be designed to meet criteria designated by the department or by an independent authority approved by the department.

(e) The department may grant variances from the requirements of subdivision (d), if the bottler, distributor, vendor of bottled water, the owner and operator of any water-vending machine, any water hauler, any retail water facility operator, or any private water source operator demonstrates either of the following:

(1) That the prescribed treatment technique is not necessary to protect the health of consumers because its water source is not subject to, nor is it likely to be subject to, significant chemical contamination.

(2) An alternative treatment technique is at least as efficient in lowering the level of contaminants to be controlled.


text: All testing of bottled water, bottled water sources, water distributed by water haulers, water from retail water facility, and water from vending machines shall be done by laboratories approved by the department, laboratories certified by the United States Environmental Protection Agency, laboratories certified by the primary enforcement authority in states that have been granted primacy by the United States Environmental Protection Agency, or laboratories certified (accredited) by a third-party organization acceptable to a primacy state.


text:
(a) Labeling and advertising of bottled water and vended water shall conform with this section, Chapter 4 (commencing with Section 110290), and applicable portions of Part 101 of Title 21 of the Code of Federal Regulations.

(b) Each container of bottled water sold in this state, each water-vending machine, and each container provided by retail water facilities located in this state shall be clearly labeled in an easily readable format. Retail water facilities that do not provide labeled containers shall post, in a location readily visible to consumers, a sign conveying required label information.

(c) Water-vending machines, retail water facilities, and private water sources that sell water at retail shall display in a position clearly visible to customers the following information:

(1) The name and address of the operator.

(2) The fact that the water is obtained from an approved public water supply or licensed private water source.

(3) A statement describing the treatment process used.

(4) If no treatment process is utilized, a statement to that effect.

(5) A toll-free telephone number or a local telephone number within the area code in which the machine is located that may be called for further information, service, or complaints, and the toll-free telephone number of the department’s food and drug branch that may be called for complaints or questions.

(6) A sign or label indicating the date on which the water-vending machine was last sanitized and serviced by the operator or maintenance personnel as required pursuant to paragraph (1) of subdivision (b) of Section 111115.

(7) A notice to consumers listing the industry’s recommendations for the type and condition of container suitable for use with the water-vending machine.

(8) A valid decal or seal received from the department indicating that a license fee has been paid and a license issued for the water-vending machine as set forth in subdivision (d) of Section 111130.

(d) The information required pursuant to subdivision (c) shall be displayed in both English and Spanish.

(e) Bottled water may be labeled “drinking water,” notwithstanding the source or characteristics of the water, only if it is processed pursuant to the Food and Drug Administration Good Manufacturing Practices contained in Section 165.110 and Parts 110 and 129 of Title 21 of the Code of Federal Regulations, Sections 12235 to 12285, inclusive, of Title 17 of the California Code of Regulations, and any other requirements established by the department pursuant to Sections 111145, 111150, and 111155. Any vended water and any water from a retail water facility may be labeled “drinking water,” notwithstanding the source or characteristics of the water, only if it is processed pursuant to Article 10 (commencing with Section 114200) of Chapter 4 of Part 7 and any other requirements established by the department pursuant to Sections 111145, 111150, and 111155.

(f) Each container of bottled water sold at retail or wholesale in this state in a beverage container shall include on its label, or on an additional label affixed to the bottle, or on a package insert or attachment, all the following:

(1) The name and contact information for the bottler or brand owner.

(2) The source of the bottled water, in compliance with applicable state and federal regulations.

(3) A clear and conspicuous statement that informs consumers about how to access water quality information contained in the bottled water report required by Section 111071.

(A) The statement shall contain all of the following:

(i) It shall include the term “water quality and information” appropriately, while informing customers about methods of gaining access to the full bottled water report.

(ii) It shall provide a telephone number, where information can be requested from the bottled water company and one other means of contact for the bottled water company, including, but not limited to, a mailing address, e-mail address, or the bottled water company’s Web site.

(B) The following statement may be used to fulfill the requirements of this paragraph: “For more information and to obtain additional consumer information relating to water quality, including a bottled water report, contact [name of bottled water company] at [telephone number or toll-free telephone number] and [at least one of the following: mailing address, e-mail address, or the bottled water company’s Web site].”

(g) Bottlers that distribute bottled or vended water directly to consumers shall provide a statement on each billing statement that includes both of the following:

(1) A telephone number and mailing address of the bottler or brand owner.

(2) The means by which a consumer may obtain consumer information relating to water quality, including a bottled water report, as described in Section 111071.

(h) Amendments made to this section by SB 220 of the 2007–08 Regular Session shall only apply to bottled water that was bottled on or after January 1, 2009.

history: (History: Amended by Stats. 2007, Ch. 575, Sec. 6. Effective January 1, 2008. Operative January 1, 2009, by Sec. 8 of Ch. 575.)


text:
(a) The labeling on bottled water sold in nonreturnable (one-way) packages in this state shall include one of the following:

(1) A telephone number of the bottler or brand owner.

(2) The bottler’s or brand owner’s mailing address.

(b) Bottlers or brand owners may also include other forms of contact, including, but not limited to, the bottler’s or brand owner’s E-mail address or website.

(c) This section shall become operative on January 1, 2002.

history: (History: Added by Stats. 2000, Ch. 533, Sec. 3. Effective January 1, 2001. Section operative January 1, 2002, by its own provisions.)


text:
In addition to the requirements of Section 111170, if a bottler, distributor, water hauler, retail water facility operator, or vending machine operator provides information in the labeling or advertising stating or implying that this water is of a specific water type (for example, “spring water”) or treated in a specific manner (for example, “purified”), the type or treatment shall be clearly labeled in an easily readable format. In order to be so labeled, the source or treatment shall conform to the definitions established in Section 165.110 of Title 21 of the Code of Federal Regulations, or, if not defined in that section, with the following criteria:

(1) “Mineralized water” means bottled or vended water that meets the requirements of “mineral water” except that the water contains added minerals.

(2) “Natural water” means bottled or vended spring, artesian well, or well water that is unmodified by mineral addition or deletion, except “natural water” may be filtered and shall be sanitized with ozone or an equivalent disinfection process and treated to reduce the concentration of any substance that exceeds safety standards established by the department.

(3) “Naturally sparkling water” means bottled water or vended water with a carbon dioxide content from the same source as the water. “Sparkling,” “carbonated,” or “carbonation added” means bottled water or vended water that contains carbon dioxide.

(4) Notwithstanding any other provision of this section, water from a public water system that is unprocessed by the bottler or vendor shall be in compliance with Section 165.110(a)(3)(ii) of Title 21 of the Code of Federal Regulations.

history: (History: Amended by Stats. 2018, Ch. 92, Sec. 150. (SB 1289) Effective January 1, 2019.)


text: Except as provided in Section 111080, any bottled water or vended water, the quality of which is below the quality required by this article, shall be labeled with a statement of substandard quality, as prescribed by subsection (b) of Section 165.110 of Subpart B of Part 165 of Title 21 of the Code of Federal Regulations.

history: (History: Amended by Stats. 2000, Ch. 533, Sec. 5. Effective January 1, 2001.)


text: Any bottler, distributor, vendor of bottled water, or owner or operator of any water-vending machine or retail water facility, whose corporate name or trademark contains the words “spring” or “springs,” or any derivative of either of these words, or “well,” “artesian well,” or “natural” shall label each bottle or vending machine with the source of the water in typeface at least equal to the size of the typeface of the corporate name or trademark, if the source of the bottled or vended water is different from the source stated in the corporate name or trademark. Retail water facilities that do not provide labeled containers shall post, in a location readily visible to consumers, a sign conveying required label information.


text:
(a) A bottled water, as defined in Section 111070, with natural or added carbonation, may be prepared with added flavors, extracts, essences, or fruit juice concentrates derived from a spice or fruit and comprising less than 1 percent by weight of the final product. The final product shall not contain sweeteners, or additives other than the flavors, extracts, essences, or fruit juice concentrates and carbon dioxide and shall be designated on labels and in advertising as follows:

(1) The common or usual name of the characterizing flavor shall accompany the designation of the bottled water product type as defined in subdivision (b) of Section 111170.

(2) The product may be designated as “natural” only if it meets the requirements for the designation as defined in paragraphs (2) and (3) of subdivision (a) of Section 111175, and naturally derived flavors, extracts, or essences are used.

(b) Products labeled pursuant to this section shall comply with all other provisions of this article. Products with one type or one source of bottled water that are labeled pursuant to this section shall not be blended with water that is not bottled water or that is of another bottled water type.

history: (History: Amended by Stats. 2018, Ch. 92, Sec. 151. (SB 1289) Effective January 1, 2019.)


text:
(a) Bottlers and water haulers that distribute directly to consumers shall provide a sentence on each billing statement that includes one of the following:

(1) A telephone number of the bottler or brand owner.

(2) The bottler’s or brand owner’s mailing address.

(b) Bottlers or brand owners may also include other forms of contact, including, but not limited to, the bottler’s or brand owner’s E-mail address or website.

(c) Bottlers and water haulers that distribute directly to consumers shall, in the billing statement, provide to new customers, and to existing customers once per year thereafter, the following statement:

“As a food product, bottled water is subject to rules and regulations promulgated by the federal Food and Drug Administration (FDA). For further information, please contact (insert the name of the bottler or brand owner) at (insert the bottler’s or brand owner’s telephone number or mailing address).”

(d) Water vending machines shall display the same information on the machines that is required under subdivisions (a) and (c).

(e) Retail water facilities shall provide new customers the same information that is required under subdivisions (a) and (c). These facilities shall also display this information in a take-home format.

(f) This section shall become operative on January 1, 2002.

history: (History: Added by Stats. 2000, Ch. 533, Sec. 6. Effective January 1, 2001. Section operative January 1, 2002, by its own provisions.)


text:
(a) The department may by written permission allow a person to package water for use in public emergencies without obtaining a water bottling license, where the emergency has resulted in the interruption of, or has compromised the quality of, the public drinking water supply. This permission may authorize the suspension of any provision of this chapter and related regulations.

(b) (1) The department may at any time change or impose on the permittee any requirements such as testing, equipment, and documentation that the department deems necessary to protect public health but in doing so shall consider the effect of those requirements in light of the urgency of the situation. The department may grant or withdraw this permission at any time.

(2) Packing, distribution, and use of water under this permit shall only be allowed during the emergency period and shall end upon the restoration of adequate public drinking supplies as determined by the department. Distribution shall be limited to the area affected. Water so packaged shall be prominently labeled “drinking water”, “for emergency use only”, and “not for sale”, or similar wording approved by the department.

(c) This section shall not be construed to restrict licensed water bottling plants from providing water processed in accordance with this chapter in emergency situations.

history: (History: Added by Stats. 2000, Ch. 533, Sec. 7. Effective January 1, 2001.)


text: The department, prior to issuing a license, shall review all labels prepared pursuant to this article, and may require any changes in order to comply with this article.


text:
The department shall post annually on its Internet Web site, in connection to the entities it regulates under this article, all of the following information:

(a) The total number of licenses, by type and county, issued in the prior calendar year.

(b) The number of inspections performed by the department in the previous calendar year, broken down by county and license type.

(c) The number and type of major violations, and the actions taken to correct those violations.

(d) The number and dollar value of fines levied under subdivision (c).

history: (History: Amended by Stats. 2012, Ch. 728, Sec. 103. (SB 71) Effective January 1, 2013.)


text:
As used in this article, the following definitions shall apply:

(a) “Hamburger” means chopped fresh or frozen beef, or a combination of both fresh or frozen beef, with or without the addition of beef fat as such, and with or without the addition of seasoning. Hamburger shall not contain more than 30-percent fat, and shall not contain added water, binders, or extenders. Beef cheek meat (trimmed beef cheeks) may be used in the preparation of hamburger to the extent of 25 percent, and if in excess of natural proportions, its presence shall be declared on the label in the ingredient statement, if any, and otherwise contiguous to the name of the product.

(b) “Imitation hamburger” means chopped fresh or frozen beef, or a combination of both fresh or frozen beef, with or without the addition of beef fat as such, and with or without the addition of seasoning. Imitation hamburger may contain binders and extenders, with or without the addition of partially defatted beef tissue, without added water or with added water only in amounts that the products’ characteristics are essentially that of a meat pattie.

(c) “Restaurant” means restaurants, itinerant restaurants, vehicles, vending machines, or institutions including hospitals, schools, asylums, eleemosynaries, and all other places where food is served to the public for consumption on the premises of sale that are not included within the definitions of the terms restaurants, itinerant restaurants, vehicles, and vending machines.

article: 13. Hamburger and Imitation Hamburger

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 13. Hamburger and Imitation Hamburger


text:
(a) If imitation hamburger is sold or served in restaurant a list of ingredients thereof shall appear on the menu, or, if there is no menu, the information shall be posted as state department shall by regulations require. No list of ingredients, however, shall be required for imitation hamburger that contains not more than 10 percent added protein and water, and that does not contain other binders or extenders.

(b) No restaurant shall use the terms “hamburger,” “burger,” or any other cognate thereof in any advertisement, or menu to refer to any imitation hamburger. A restaurant selling or serving imitation hamburger may refer to the product as imitation hamburger or by any other term that accurately informs the customer of the nature of the food product that he or she is sold or served.

article: 13. Hamburger and Imitation Hamburger


text: It is unlawful and constitutes misbranding for any person to advertise, offer for sale, sell, or serve as hamburger or imitation hamburger in any restaurant any product that does not come within the definitions of those terms contained in Section 111200. It is unlawful and constitutes misbranding for any person to violate any provision of this article or any regulation adopted pursuant thereto.

article: 13. Hamburger and Imitation Hamburger


text: It is the public policy of this state to require restaurants selling hamburger and imitation hamburger to accurately inform the consumer public of the contents of foods.

article: 13. Hamburger and Imitation Hamburger


text: This article shall be enforced by the same persons and in the same manner as provided in Article 7 (commencing with Section 28690) of Chapter 11 of Division 22.

article: 13. Hamburger and Imitation Hamburger


text:
For purposes of this article the following definitions shall apply:

(a) “Asian rice-based noodle” is defined as a rice-based pasta that contains rice powder, water, wheat starch, vegetable cooking oil, and optional ingredients to modify the pH or water activity, or to provide a preservative effect. The ingredients shall not include any animal fats or any other products derived from animals. An Asian rice-based noodle is prepared by using a traditional method that includes cooking by steaming at not less than 130 degrees Fahrenheit, for not less than four minutes.

(b) “Korean rice cake” is defined as a confection that contains rice powder, salt, sugar, various edible seeds, oil, dried beans, nuts, dried fruits, and dried pumpkin. The ingredients may not include any animal fats or any other products derived from animals. A Korean rice cake is prepared by using a traditional Korean method that includes cooking by steaming at not less than 275 degrees Fahrenheit, for not less than five minutes, nor more than 15 minutes.

(c) “Vietnamese rice cake,” also known as Bánh Tét or Bánh Chưng, is defined as a confection that contains a combination of rice, beans, and meat or fruit wrapped tightly in banana leaves for cooking. Bánh Tét is a rice cake in a cylindrical shape, and Bánh Chưng is a rice cake in a square shape. A Vietnamese rice cake is prepared using a traditional Vietnamese method that includes cooking by boiling in water for not less than 10 hours. Vietnamese rice cakes are required to be handled, prepared, and stored under sanitary conditions both when they are kept at no more than 70 degrees Fahrenheit upon completion of cooking and after the rice cakes have been cooled to below 70 degrees Fahrenheit. Any Vietnamese rice cakes that are unwrapped from the banana leaves after cooking shall be refrigerated.

history: (History: Amended by Stats. 2016, Ch. 193, Sec. 2. (SB 969) Effective January 1, 2017.)

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 14. Asian Rice Noodles, Korean Rice Cakes, and Vietnamese Rice Cakes


text:
(a) (1) All manufacturers of Asian rice-based noodles shall place a label on the packaging of Asian rice-based noodles that indicates the date and time that the product first came out of hot holding at temperatures above 135 degrees Fahrenheit and includes a statement that the Asian rice-based noodles are perishable.

(2) The product packaging shall only be labeled once.

(3) Notwithstanding paragraphs (1) and (2), this section shall not apply to Asian rice-based noodles that have a pH of 4.6 or below, have a water activity of 0.85 or below, or have been determined by the department to be nonpotentially hazardous foods based on formulation and supporting laboratory documentation submitted to the department by the manufacturer.

(b) All manufacturers of Korean rice cakes shall place a label issued by the Korean Rice Cake Association Corporation on the Korean rice cake that indicates the date of manufacture. The Korean rice cakes label shall include a statement that the rice cake must be consumed within one day of manufacture.

(c) (1) All manufacturers of Vietnamese rice cakes shall place a label, designed by the Vietnamese Rice Cake Association, Inc., on the Vietnamese rice cake that indicates the date and time the cooking process was completed. The Vietnamese rice cakes label shall include a statement that the rice cake must be consumed within 24 hours of the date and time printed on the label.

(2) Notwithstanding paragraph (1), this section does not apply to Vietnamese rice cakes that have been determined by the department to be nonpotentially hazardous foods based on formulation and supporting laboratory documentation submitted to the department by the manufacturer.

history: (History: Amended by Stats. 2016, Ch. 193, Sec. 3. (SB 969) Effective January 1, 2017.)

article: 14. Asian Rice Noodles, Korean Rice Cakes, and Vietnamese Rice Cakes


text:
For purposes of this article, the following terms have the following meanings:

(a) “Eviscerate” or “evisceration” means the processor’s action of removing and discarding the entire intestinal tract, hepatopancreas, and all associated abdominal organs in accordance with this article.

(b) “Eviscerated crab” means Dungeness crab or rock crab in which the viscera have been removed in accordance with regulations adopted pursuant to this section.

(c) “Hazard Analysis Critical Control Point plan” means a hazard analysis critical control point plan as described in Section 123.6 of Title 21 of the Code of Federal Regulations or a successor federal definition.

(d) “Processor” means any person engaged in commercial, custom, or institutional processing of fish or fishery products in California, in another state, or in a foreign country. A processor includes any person engaged in the production of foods that are to be used in market or consumer tests.

history: (History: Added by Stats. 2021, Ch. 757, Sec. 10. (SB 80) Effective October 9, 2021.)

article: 15. Eviscerated Crab

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 15. Eviscerated Crab


text:
The department shall issue an order authorizing the evisceration of Dungeness crab or rock crab pursuant to this article if the domoic acid for Dungeness crab or rock crab exceeds the allowable levels for viscera in a specified area, when all of the following criteria exist:

(a) The Director of Fish and Wildlife has closed waters or otherwise restricted the take of Dungeness crab or rock crab for commercial purposes pursuant to Section 5523 of the Fish and Game Code due to the viscera of the Dungeness crab or rock crab exceeding the allowable levels of domoic acid.

(b) The department has determined the viscera of the Dungeness crab or rock crab exceed the allowable levels of domoic acid.

(c) The department has determined the corresponding meat of the Dungeness crab or rock crab does not exceed the allowable levels of domoic acid.

article: 15. Eviscerated Crab


text:
(a) (1) The department shall only authorize the evisceration of Dungeness crab or rock crab pursuant to this article by a processor that is licensed pursuant to Article 2 (commencing with Section 110460) and that has a Hazard Analysis Critical Control Point plan approved by the department for handling and preparing eviscerated crab.

(2) The department shall collect from a processor a fee of three hundred fifty dollars ($350) for the cost of reviewing the processor’s Hazard Analysis Critical Control Point plan for handling and preparing eviscerated crab. This fee shall not exceed the cost of reviewing the Hazard Analysis Critical Control Point plan and shall be adjusted pursuant to Section 100425. All moneys collected by the department from this fee shall be deposited in the Food Safety Fund established pursuant to Section 110050 for expenditure by the department, upon appropriation by the Legislature, for the costs of reviewing Hazard Analysis Critical Control Point plans for handling and preparing eviscerated crab.

(3) The department shall establish requirements for labeling eviscerated crab to identify harvest location, harvest date, or lot code, or any combination of these things.

(4) The department shall require the processor to maintain written recall procedures.

(b) (1) The department shall consult with the Dungeness crab task force established pursuant to Section 8276.4 of the Fish and Game Code or a successor task force or committee to establish the criteria for the manufacture, sale, delivery, holding, or offering for sale of Dungeness crab or rock crab that is subject to Section 111224.5.

(2) The Dungeness crab or rock crab criteria established under this subdivision shall become effective by operation of law as a regulation adopted under this article 90 days after the department publishes the notice required by paragraph (3).

(3) The department shall publish a notice in the California Regulatory Notice Register of the department’s proposed Dungeness crab or rock crab criteria. The notice shall include the proposed text and justification for the addition, change, or deletion of the Dungeness crab or rock crab criteria to allow public comment. The department shall consider the public comments.

(c) This section shall not be subject to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.

article: 15. Eviscerated Crab


text:
As used in this chapter, with respect to a drug or drug ingredient, “established name” means either of the following:

(a) The name designated pursuant to Section 508 of the federal act (21 U.S.C. Sec. 358).

(b) If there is no such name and the drug or ingredient is an article recognized in an official compendium, then the official title in the compendium is the established name.

If neither subdivision (a) or (b) of this section applies, the common or usual name, if any, of the drug or of the ingredient is the established name. When an article is recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia shall apply unless it is labeled and offered for sale as a homeopathic drug. If it is labeled and offered for sale as a homeopathic drug, the official title used in the Homeopathic Pharmacopoeia shall apply.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

chapter: 6. Drugs and Devices

article: 1. General Provisions

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 1. General Provisions


text: Any drug represented in its labeling or advertisement as an antiseptic shall be considered to be represented as a germicide, except in the case of a drug that is purported to be or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use involving prolonged contact with the body.

article: 1. General Provisions


text: Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug. If it is labeled and offered for sale as a homeopathic drug, it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

article: 1. General Provisions


text: Any added poisonous or deleterious substance, or color additive, shall be considered unsafe for use with respect to any drug or device unless there is in effect a regulation adopted pursuant to Section 110090 that prescribes its use in or on drugs or devices.

article: 1. General Provisions


text: The department may establish performance standards for devices, that shall be designed to provide reasonable assurance of safe and effective performance and, where appropriate, requiring the use and prescribing the form and content of labeling for the proper installation, maintenance, operation, or use of the device. However, if a performance standard is established for a device pursuant to Section 514 of the federal act (21 U.S.C. Sec. 360d) or Section 521 of the federal act (21 U.S.C. Sec. 360k), it shall be the performance standard of this state for device.

article: 1. General Provisions


text: Commencing January 1, 2002, any product used for the treatment of lice or scabies in human beings that contains the pesticide Lindane shall not be used or sold in the state.

history: (History: Added by Stats. 2000, Ch. 326, Sec. 2. Effective January 1, 2001.)

article: 1. General Provisions


text: Any drug or device is adulterated if it consists, in whole or in part, of any filthy, putrid, or decomposed substance.

article: 2. Adulterated Drugs or Devices

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if it has been produced, prepared, packed, or held under conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it purports or is represented to possess.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if it is packaged and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if it bears or contains for the purpose of coloring only a color additive that is unsafe within the meaning of Section 111240.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if it is a color additive, the intended use of which in or on drugs or devices is for the purpose of coloring only, and it is unsafe within the meaning of Section 111240.

article: 2. Adulterated Drugs or Devices


text: Any drug is adulterated if it purports to be, or is represented as, a drug that is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in the compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of the tests or methods of assay, those prescribed under authority of this part. No drug defined in an official compendium shall be deemed to be adulterated under this section because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on the label.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if its strength differs from, or its purity or quality is below, that which it is represented to possess.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is adulterated if any substance has been mixed or packed with it so as to reduce its quality or strength or if any substance has been substituted, wholly or in part, for the drug or device.

article: 2. Adulterated Drugs or Devices


text: It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is adulterated.

article: 2. Adulterated Drugs or Devices


text: It is unlawful for any person to adulterate any drug or device.

article: 2. Adulterated Drugs or Devices


text: It is unlawful for any person to receive in commerce any drug or device that is adulterated or to deliver or proffer for delivery any drug or device.

article: 2. Adulterated Drugs or Devices


text: While any regulation described in Section 110090 relating to any color additive is in effect, any drug or device that bears or contains the color additive in accordance with the regulation shall not be considered adulterated.

article: 2. Adulterated Drugs or Devices


text:
Any drug or device intended for export shall not be deemed to be adulterated under this part if it satisfies all of the following requirements:

(a) It accords to the specifications of the foreign purchaser.

(b) It is not in conflict with the laws of the importing country.

(c) It is labeled on the outside of the shipping package to show that it is intended for export.

If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part.

article: 2. Adulterated Drugs or Devices


text: Any device is adulterated that fails to meet the applicable performance standard, if any, as provided in Section 111245.

article: 2. Adulterated Drugs or Devices


text: A drug or device is deemed adulterated under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, relating to tamper-resistant packaging, but is not in compliance therewith.

article: 2. Adulterated Drugs or Devices


text: Any drug or device is misbranded if its labeling is false or misleading in any particular.

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 7. Effective January 1, 2001.)

article: 3. Misbranded Drugs or Devices

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 6. Drugs and Devices > 3. Misbranded Drugs or Devices


text: Any drug or device is misbranded if its labeling or packaging does not conform to the requirements of Chapter 4 (commencing with Section 110290).

article: 3. Misbranded Drugs or Devices


text:
Any drug or device is misbranded unless it bears a label containing all of the following information:

(a) The name and place of business of the manufacturer, packer, or distributor.

(b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

Reasonable variations from the requirements of subdivision (b) shall be permitted. Requirements for placement and prominence of the information and exemptions as to small packages shall be established in accordance with regulations adopted pursuant to Section 110380.

article: 3. Misbranded Drugs or Devices


text: Any drug or device is misbranded if any word, statement, or other information required by or under this part to appear on the label or labeling is not prominently placed on the label or labeling with conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

article: 3. Misbranded Drugs or Devices


text:
(a) Any drug is misbranded unless its label bears, to the exclusion of any other nonproprietary name except the applicable, systematic chemical name or the chemical formula, all of the following information:

(1) The established name of the drug, if any.

(2) If it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein.

(3) For nonprescription drugs, the quantity or proportion of each active ingredient and the established name of each inactive ingredient in accordance with Sections 502(e)(1)(A)(ii) and (iii) of the federal act (21 U.S.C. 352(e)(1)(A)(ii) and (iii)).

(b) The requirement for stating the quantity of the active ingredients of any drug, including the quantity or proportion of any alcohol, and also including, whether active or not, the quantity or proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein, shall apply to all drugs, including prescription drugs and nonprescription drugs. However, the requirement for declaration of quantity shall not apply to nonprescription drugs that are also cosmetics, as defined in Section 201(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 321(i)) and that are labeled in compliance with federal labeling requirements concerning declaration of ingredients including active ingredients and also the quantity and proportion of any alcohol, except that the quantity or proportion of the following ingredients, whether active or not, shall be declared: bromides, ether, chloroform, acetanilide, acetophenetidin, antipyrine, atropine, hyoscine, hyoscyamine, codeine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, barbituric acid, or any derivative or preparation of any substances contained therein. The department may exempt any nonprescription drug from the requirement of stating the quantity of the active ingredients, other than those specifically named in this subdivision, upon a showing by the applicant through evidence satisfactory to the department that the granting of the exemption will not endanger the public health. For any prescription drug the established name of the drug or ingredient, as the case may be, on the label and on any labeling on which a name for the drug or ingredient is used shall be printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for the drug or ingredient.

The changes made in this section by Chapter 943 of the Statutes of 1978 shall not apply to any drug shipped by a manufacturer or packer to a retailer or wholesaler before January 1, 1980. Any such drugs so shipped shall comply with this section on and after January 1, 1981.

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 9. Effective January 1, 2001.)

article: 3. Misbranded Drugs or Devices


text:
Any drug subject to Section 111470 is misbranded unless the manufacturer, packer, or distributor of the drug includes, in all advertisements and other descriptive matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug, a true statement of all of the following:

(a) The established name, printed prominently and in a type at least half as large as that used for any proprietary name of the drug.

(b) The formula showing quantitatively each ingredient of the drug to the extent required for labels under Section 111355.

(c) The name and place of business of the manufacturer that produced the finished dosage form of the drug, as prescribed by regulations issued by the department. This subdivision applies only to advertisements or descriptive matter issued for drugs manufactured in finished dosage form on or after April 1, 1973.

(d) Such other information, in brief summary relating to side effects, contraindications, and effectiveness as shall be required by regulations promulgated by the department.

Regulations relating to side effects, contraindications, and effectiveness issued pursuant to Section 502(n) of the federal act (21 U.S.C. Sec. 352(n)) are the regulations establishing information requirements relating to side effects, contraindications and effectiveness in this state. The department may, by regulation, make other requirements relating to side effects, contraindications, and effectiveness whether or not in accordance with the regulations adopted under the federal act.

article: 3. Misbranded Drugs or Devices


text:
Any drug subject to Section 111470 is misbranded unless the established name of the prescription drug or prescription drug ingredient is printed on the label prominently and in type at least half as large as that used for the proprietary name or designation on the label, labeling, or advertising.

The department may, by regulation, establish exemptions from the requirements of this section when compliance with this section is not considered necessary for the protection of health and safety.

article: 3. Misbranded Drugs or Devices


text:
Any drug or device is misbranded unless its labeling bears all of the following information:

(a) Adequate directions for use.

(b) Such adequate warnings against use in pathological conditions or by children where its use may be dangerous to health.

(c) Adequate warning against unsafe dosage or methods or duration of administration or application.

Warnings shall be in a manner and form as are necessary for the protection of users.

If the department determines that any requirement of subdivision (a), as applied to any drug or device, is not necessary for the protection of the public health, the department may adopt regulations exempting the drug or device from these requirements.

Any drug or device exempted under Section 502(f) of the federal act (21 U.S.C. Sec. 352(f)) is exempt from the requirement of this section. The department, however, may adopt any regulation including a drug or device within, or excluding a drug or device from the requirements of this section, whether or not the inclusion or exclusion of the drug or device is in accord with the federal act.

article: 3. Misbranded Drugs or Devices


text:
(a) The department may adopt regulations relating to brand name or generic mifepristone or any drug used for medication abortion by including brand name or generic mifepristone or any drug used for medication abortion within, or excluding brand name or generic mifepristone or any drug used for medication abortion from, the requirements of this article, whether or not the inclusion or exclusion of the drug is in accordance with federal law.

(b) Notwithstanding any other state law, and consistent with Sections 1 and 1.1 of Article I of the California Constitution, this article shall not apply to brand name or generic mifepristone in the event of a labeling change or in the absence of its United States Food and Drug Administration approval if it is recommended for use by the World Health Organization and its labeling was true and accurate at the time of manufacture, except if the state deems it necessary to address an imminent health or safety concern regarding brand name or generic mifepristone.

history: (History: Added by Stats. 2025, Ch. 136, Sec. 17. (AB 260) Effective September 26, 2025.)

article: 3. Misbranded Drugs or Devices


text: Any drug is misbranded if it purports to be a drug that is recognized in an official compendium and it is not packaged and labeled as prescribed in the official compendium. The method of packaging, however, may be modified with the consent of the department.

article: 3. Misbranded Drugs or Devices


text: Any drug or device is misbranded if the department determines that the drug or device is liable to deterioration, unless it is packaged in that form and manner and its label bears a statement of the precautions, as the department, by regulation, may require as necessary for the protection of public health. Such regulations shall not be established for any drug or device recognized in an official compendium, unless the department has informed the appropriate body, charged with the revision of the official compendium, of the need for that packaging or labeling requirements and that body has not prescribed the requirements in a reasonable length of time.

article: 3. Misbranded Drugs or Devices


text: Any drug or device is misbranded if its container is so made, formed, or filled as to be misleading.

article: 3. Misbranded Drugs or Devices


text:
Any drug is misbranded in any of the following cases:

(a) It is an imitation of another drug.

(b) It is offered for sale under the name of another drug.

(c) The contents of the original package have been, wholly or partly, removed and replaced with other material in the package.

article: 3. Misbranded Drugs or Devices


text:
(a) Any foreign dangerous drug that is not approved by the United States Food and Drug Administration or that is obtained outside of the licensed supply chain regulated by the United States Food and Drug Administration, California State Board of Pharmacy, or State Department of Public Health is misbranded.

(b) Any foreign dangerous drug that is imported lawfully under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or pursuant to an announcement by the United States Food and Drug Administration of the exercise of enforcement discretion for instances including, but not limited to, clinical research purposes, drug shortages, development of countermeasures against chemical, biological, radiological, and nuclear terrorism agents, or pandemic influenza preparedness and response is not misbranded.

history: (History: Added by Stats. 2014, Ch. 492, Sec. 13. (SB 600) Effective January 1, 2015.)

article: 3. Misbranded Drugs or Devices


text: Any drug or device is misbranded if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling.

article: 3. Misbranded Drugs or Devices


text: Any drug is misbranded if it is a color additive, intended for use in or on drugs for the purpose of coloring only and its packaging and labeling fail to conform to the packaging and labeling requirements adopted pursuant to Section 110090.

article: 3. Misbranded Drugs or Devices


text: A drug or device is misbranded if a trademark, trade name, or other identifying mark, imprint, or device of another person, or any likeness of the trademark, trade name, or other identifying mark, imprint, or device of another person, has been placed on the drug or device, or upon its container.

article: 3. Misbranded Drugs or Devices


text: A drug or device is misbranded if it was manufactured in this state in an establishment not duly licensed as provided in this part.

article: 3. Misbranded Drugs or Devices


text: A drug or device is misbranded if it was manufactured in an establishment not duly registered with the Secretary of Health, Education, and Welfare of the United States.

article: 3. Misbranded Drugs or Devices


text: Any drug is misbranded if its packaging or labeling is in violation of an applicable regulation issued pursuant to Section 108685 or 108700.

article: 3. Misbranded Drugs or Devices


text: It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any drug or device that is misbranded.

article: 3. Misbranded Drugs or Devices


text: It is unlawful for any person to misbrand any drug or device.

article: 3. Misbranded Drugs or Devices


text: It is unlawful for any person to receive in commerce any drug or device that is misbranded or to deliver or proffer for delivery any drug or device.

article: 3. Misbranded Drugs or Devices


text: It is unlawful for any person to alter, mutilate, destroy, obliterate, or remove the label or any part of the labeling of any drug or device if the act results in the drug or device being misbranded.

article: 3. Misbranded Drugs or Devices


text:
Any drug or device intended for export shall not be deemed to be misbranded under this part if it satisfies all of the following requirements:

(a) It accords to the specifications of the foreign purchaser.

(b) It is not in conflict with the laws of the importing country.

(c) It is labeled on the outside of the shipping package to show that it is intended for export.

If the article is sold or offered for sale in domestic commerce, this section shall not exempt it from any of the provisions of this part.

article: 3. Misbranded Drugs or Devices


text: A drug or device is deemed misbranded under the laws of this state if it is subject to regulations issued by the United States Food and Drug Administration relating to tamper-resistant packaging, as set forth in Parts 200, 211, 314, and 800 of Volume 21 of the Code of Federal Regulations, as amended, but is not in compliance therewith.

article: 3. Misbranded Drugs or Devices


text:
The following drugs or devices, that are intended for use by man, shall be sold only upon a written prescription of a practitioner licensed by law to prescribe the drug or device, or upon an oral prescription of the licensee that is reduced promptly to writing and filed by the pharmacist, or by refilling the written or oral prescription if the refilling is authorized by the prescriber either in the original prescription or by oral order that is reduced promptly to writing and filed by the pharmacist:

(a) A habit forming drug to which Section 111350 applies.

(b) A drug or device that, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer the drug or device.

(c) A drug or device for which adequate directions cannot be written for persons, who are not practitioners licensed by law to prescribe the drug or device, for safe and effective self-medication or treatment by those persons, who are not practitioners licensed by law to prescribe the drug or device.

(d) A drug or device that is limited by an effective application under Section 505 of the federal act (21 U.S.C. Sec. 355) or Section 111550 to use under the professional supervision of a practitioner licensed by law to administer the drug or device.

If any prescription for the drug does not indicate the number of times it may be refilled, if any, the prescription may not be refilled unless the pharmacist obtains a new order from the practitioner.

article: 3. Misbranded Drugs or Devices


text: The act of selling a drug or device contrary to Section 111470 shall be deemed to be an act that results in the drug or device being misbranded while held for sale.

article: 3. Misbranded Drugs or Devices