Medical Waste Regulations

1. Introduction.

1.1 What Is Medical Waste?

Medical waste can include any of the following waste types:

Biohazardous waste:

• waste derived from the medical treatment of a human or from an animal that is suspected by the vet of being infected with a pathogen that is infectious to humans, or from biomedical research.
• waste from a laboratory, such as human specimen cultures or animal specimen cultures that are infected with pathogens that are infectious to humans; cultures and stocks of infectious agents from research; wastes from the production of bacteria, viruses, spores, discarded live and attenuated vaccines used in human health care or research, discarded animal vaccines.
• waste that contains recognizable fluid human blood or blood from animals suspected by the vet of being contaminated with infectious agents known to be contagious to humans.
• waste contaminated with excretion, exudate, or secretions from humans or animals that are required to be isolated by the infection control staff, the attending physician or vet, to protect others from highly communicable diseases.

Sharps waste:

• any medical waste that has rigid edges, or protuberances capable of cutting or piercing. i.e hypodermic needles, syringes, blades, needles with attached tubing, acupuncture needles, root canal files, broken glass items used in healthcare, tattoo needles contaminated with biohazardous waste, and any item capable of cutting or piercing from trauma scene waste. Sharps waste must be contained in sharps containers.

Pharmaceutical waste:

• unused, expired or outdated prescription or over-the-counter human or veterinary drugs, that are not regulated by the RCRA Act.

Pathology waste:

• human body parts, with the exception of teeth, removed at surgery, and surgery specimens or tissues removed at surgery or autopsy that are suspected of being contaminated with infectious agents known to be contagious to humans or having been fixed in formaldehyde or other fixatives.
• animal parts, tissues, fluids, or carcasses suspected by the attending vet of being contaminated with infectious agents known to be contagious to humans.

Trace-Chemo waste:

• any waste that is contaminated through contact with, or having previously contained a chemotherapeutic agent i.e. gloves, disposable gowns, towels, and intravenous solution bags and attached tubing that are empty.

Trauma scene waste:

• waste that has been removed, is to be removed, or is in the process of being removed, from a trauma scene by a trauma scene waste management practitioner.

Incineration waste:

• incineration waste is a term used to describe waste that is typically disposed of through incineration. Therefore, “incineration waste” could include pharmaceutical waste, pathology waste and Trace-Chemo waste.

See Medical Waste Management Act, section 117690 and 117747

1.2 Proper Treatment & Disposal

In accordance with medical waste regulations, medical waste should only be transported to a treatment facility, by an authorized transporter. When medical waste is being transported to a permitted medical waste treatment facility, medical waste shall not be unloaded, reloaded, or transferred to another vehicle at any location, except at a permitted medical waste transfer station or in the case of a vehicle breakdown or other emergency.

Biohazardous waste, should be treated by approved steam sterilization at a permitted medical waste treatment facility or by approved incineration at a permitted medical waste treatment facility, or by alternative treatments approved to treat this type of waste.

Medical waste regulations dictate that fluid blood or fluid blood products may be discharged to a public sewage system without treatment if its discharge is consistent with waste discharge requirements placed on the public sewage system by the California regional water quality control board with jurisdiction.

Sharps waste shall be rendered noninfectious prior to disposal by incineration, steam sterilization or by disinfection using an alternative treatment method approved by the department. Sharps waste rendered noninfectious may be disposed of as solid waste if the waste is not otherwise hazardous.

Pharmaceutical waste should be treated by approved incineration, at a permitted medical waste treatment facility, or by alternative treatments approved to treat this type of waste.

Anatomical Parts of a human nature that is Pathology waste shall be disposed of by interment, incineration, or by alternative treatments that meet medical waste regulations to treat this type of waste.

Trace-Chemo waste should be treated by approved incineration at a permitted medical waste treatment facility, or by alternative treatments approved to treat this type of waste.

See Medical Waste Management Act, Section 118000, 118035, 118215, 118220, 118222 and 118225

2. Requirements.

2.1 Handling And Containerization

When handling medical waste and adhering to medical waste regulations, use puncture proof personal protective equipment (PPE). Extreme caution should be taken when handling medical waste, especially sharps waste. All personnel handling medical waste should be trained annually in OSHA’s Blood-Borne Pathogen Standards. Medical waste shall be contained separately from other wastes at its point of origin.

The use of biohazard bags is of the utmost importance in medical waste regulations. Biohazardous waste, shall be placed in biohazard bags which should be tied to prevent leakage or expulsion of contents during all future storage and handling. The bags should be placed for storage and transport in a rigid container that may be disposable, reusable, or recyclable. Containers shall be leak resistant, have tight-fitting covers, and be kept clean and in good repair. Containers may be of any color and shall be labeled with the words “Biohazardous Waste” or with the international biohazard symbol. The word “BIOHAZARD” should be imprinted on the lid and sides so as to be visible from any lateral direction. Containers shall comply with DOT medical waste regulations when prepared for transport offsite from the facility. Biohazardous waste shall not be removed from the biohazard bag until treatment is completed, except to eliminate a safety hazard, or by the enforcement officer in performance of an investigation. A biohazard bag is a disposable film bag used to contain medical waste. Biohazard bags that are used to line containers that transport medical waste from the generator’s facility to a disposal facility shall be:

• marked by the manufacturer as having passed the tests prescribed in the American Society for Testing Materials for the “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” (ASTM D1922), and the “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method” (ASTM D1709).
• red in color, except when yellow bags are used to further segregate trace chemotherapy waste and white bags are used to further segregate pathology waste.
• marked with the international biohazard symbol.

Medical waste regulations dictate that sharps waste shall only be contained in sharps containers. A sharps container is a rigid puncture-resistant container used in patient care or research, meeting the standards of, and receiving approval from the FDA, as a medical device used for the collection of discarded medical needles or other sharps. Sharps containers shall not be lined with a plastic bag or inner liner. To containerize sharps waste, a person shall do all of the following:

• place all sharps waste into a sharps container.
• tape closed, or tightly lid, any full sharps containers ready for disposal to preclude loss of contents.
• store sharps containers ready for disposal for not more than thirty days, without the written approval of the enforcement agency.
• label sharps containers with the words “Sharps Waste” or with the international biohazard symbol and the word “BIOHAZARD.”

Sharps containers may be placed in biohazard bags or in containers with biohazard bags.

To comply with medical waste regulations, pharmaceutical waste shall be placed in containers that are labeled with the words “HIGH HEAT” or “INCINERATION ONLY”, on the sides and on its lid, so as to be visible from any lateral direction. Pharmaceutical wastes classified by the DEA as “controlled substances” shall be disposed of in accordance with DEA requirements. Pharmaceutical waste and sharps waste can be consolidated in the same sharps container, provided that the consolidated wastes are treated by incineration, which is an approved treatment method for both wastes and the container must be labeled with the biohazardous waste symbol as well as the words “HIGH HEAT” or “INCINERATION ONLY”. Pharmaceutical waste should be maintained in a manner to secure the pharmaceutical waste contents from access by unauthorized individuals. Any suspected or confirmed tampering of, unauthorized access to, or loss of the pharmaceutical waste shall be reported to the appropriate state licensing authority.

Pathology waste should be segregated for storage and its container and its lid, should be labeled with the words “Pathology Waste”, so as to be visible from any lateral direction.

Trace-Chemo waste should be segregated for storage, and its container and its lid should be labeled with the words “Chemotherapy Waste”, so as to be visible from any lateral direction. Sharps waste that is contaminated through contact with or having previously contained, chemotherapeutic agents, should be placed in sharps containers labeled with the words “Chemotherapy Waste”. A person shall thoroughly wash and decontaminate reusable rigid containers for medical waste by a method approved by the enforcement agency’s regulations each time they are emptied, unless the surfaces of the containers have been completely protected from contamination by disposable liners, bags, or other devices removed with the waste. These containers shall be maintained in a clean and sanitary manner. Medical waste regulation approved methods of decontamination include, but are not limited to, agitation to remove visible soil combined with one of the following procedures:

• exposure to hot water of at least 82° Centigrade (180° Fahrenheit) for a minimum of 15 seconds.
• exposure to chemical sanitizer by rinsing with, or immersion in, one of the following for a minimum of three minutes: (1) Hypochlorite solution (500 ppm available chlorine). (2) Phenolic solution (500 ppm active agent). (3) Iodoform solution (100 ppm available iodine). (4) Quaternary ammonium solution (400 ppm active agent).

Any leak or spill of medical waste by a medical waste generator, hazardous waste hauler, or treatment facility shall be decontaminated by procedures adopted by the department’s regulations. A person shall not use reusable pails, drums, dumpsters, or bins used for medical waste for the containment of solid waste, or for other purposes, except after being decontaminated by the approved procedures mentioned above in the section, and removal of all medical waste labels.

See Medical Waste Management Act, section 117630, 117750, 118033, 118275, 118280, 118285, 118295, 118300 and 118305.

2.2 Storage

Any medical waste that is transported off site for treatment and disposal, should be stored in rigid DOT approved containers, and the lid and sides of the container must be labeled according to the waste contained inside. When medical waste is containerized, there is no requirement to label the containers with the date that the waste started to accumulate.
Medical waste should be stored in containers to await transport for treatment, in a designated accumulation area. The accumulation area should be secured so as to deny access to unauthorized persons, and to protect from animals and natural elements. The area shall not provide a breeding place, or a food source for insects or rodents. The storage area may be secured by use of locks on entry doors, gates, or receptacle lids. The designated medical waste accumulation area shall be marked with warning signs on, or adjacent to, the exterior of entry doors, gates, or lids. The wording that is both in English and in Spanish should be:

“CAUTION—BIOHAZARDOUS WASTE STORAGE AREA—UNAUTHORIZED PERSONS KEEP OUT”

“CUIDADO— ZONA DE RESIDUOS—BIOLOGICOS PELIGROSOS—PROHIBIDA LA ENTRADA PERSONAS NO AUTORIZADAS”

It may be needed to be written in another language, in addition to English, determined to be appropriate by infection control staff or the enforcement agency. Warning signs shall be readily legible during daylight from a distance of at least 25 feet. Medical waste that is stored in an intermediate storage area, prior to transfer to the designated medical waste accumulation area, shall be stored in an area that is either locked or under direct supervision or surveillance. Intermediate storage areas shall be marked with the international biohazard symbol or the signage described above in this section. These warning signs shall be readily legible from a distance of five feet. This does not apply to the rooms in which medical waste is generated. A person shall not use a trash chute to transfer medical waste.

See Medical Waste Management Act, section 118307, 118310 and 118315.

2.3 Service Frequency

In California, the medical waste regulations are as follows: If you generate more than 20 pounds of biohazardous waste per month, you may store your medical waste onsite for up to seven days. If you generate less than 20 pounds of biohazardous waste per month, you may store your medical waste onsite for up to 30 days.

If you are storing your biohazardous waste at or below 32° fahrenheit i.e. in a freezer, you may store your medical waste on-site for up to 90 days. If it is pharmaceutical waste that you are storing, you may store the waste on site for up to 90 days, from when the container is ready for disposal. According to medical waste regulations, the container shall be emptied at least once per year.
Odor and storage considerations may require that you remove your waste more frequently.

See Medical Waste Management Act, section 118280.

2.4 Tracking Documents

A medical waste tracking document is a document (electronic or paper) that tracks medical waste from the point of its origin, until the point that the waste is properly treated. This is also sometimes referred to as “cradle to grave” tracking. At the time that the medical waste is received by a medical waste transporter, the transporter shall provide the medical waste generator with a copy of the tracking document. The transporter transporting medical waste shall maintain its copy of the tracking document for three years.

The tracking document shall include, but not be limited to, all of the following information:
(1) The name, address, telephone number, and registration number of the transporter.
(2) The type of medical waste transported and the quantity or aggregate weight of the medical waste transported.
(3) The name, address, and telephone number of the generator.
(4) The name, address, telephone number, permit number, and the signature of an authorized representative of the permitted facility receiving the medical waste.
(5) The date that the medical waste is collected or removed from the generator’s facility, the date that the medical waste is received by the transfer station, the registered large quantity generator, or point of consolidation, if applicable, and the date that the medical waste is received by the treatment facility.

A medical waste transporter transporting medical waste in a vehicle shall have the tracking document in his or her possession while transporting the medical waste. The tracking document shall be shown upon demand to any enforcement agency personnel or officer of the Department of the California Highway Patrol. A medical waste transporter transporting medical waste shall provide the facility receiving the medical waste with the original tracking document.

To see a sample tracking document, click here.

See Medical Waste Management Act, Section 118040.

3. Medical Waste Generators.

3.1 General

A medical waste generator is any person whose act or process produces medical waste. All of the following are examples of businesses that generate medical waste:

• Medical and dental offices, clinics, hospitals, surgery centers, laboratories and dialysis clinics.
• Skilled nursing facilities, assisted living facilities and board and cares.
• Research and education facilities.
• Veterinary offices, clinics and veterinary hospitals.
• Pet shops and zoos.
• Tattoo shops.

See Medical Waste Management Act, section 117705.

3.2 Small Quantity Generators

A small quantity generator is a medical waste generator that generates less than 200 pounds per month of medical waste. A small quantity medical waste generator must follow all applicable rules put forth in the Medical Waste Management Act regarding the handling, storage and treatment of medical waste, and should maintain on file in its office, all of the following:

• an information document stating how the generator contains, stores, treats, and disposes of any medical waste generated through any act or process of the generator.
• the tracking documents for all untreated medical waste shipped off site for treatment, kept for three years. Documentation shall be made available to the enforcement agency onsite.

See Medical Waste Management Act, section 117760 and 117945.

3.3 Large Quantity Generators

A large quantity generator is a medical waste generator that generates 200 or more pounds of medical waste in any month, of a 12-month period. Large quantity generators must:

• register with the enforcement agency prior to commencement of the generation of medical waste. Each medical waste registration issued by the enforcement agency for large quantity generators shall be valid for one year. An application for renewal of the registration shall be filed with the enforcement agency not less than 90 days prior to the expiration date
• be subject to at least annual inspection by the enforcement agency.
• maintain tracking documents for any untreated medical waste transported off site for treatment.


• file a medical waste management plan with the enforcement agency. Generators shall update their medical waste management plan when any of the information in the plan changes and shall have the plan on file for review during an inspection or upon request. The updated plan shall be submitted within 30 days of the change. A “medical waste management plan” is a document that is completed by medical waste generators that describes how the medical waste generated at their facility shall be segregated, handled, stored, packaged, treated, or shipped for treatment. The medical waste management plan should contain all of the following: (a) The name of the person. (b) The business address of the person. (c) The type of business. (d) The types, and the estimated average monthly quantity, of medical waste generated. (e) The type of treatment used on site, if applicable. For generators with onsite medical waste treatment facilities, the treatment capacity of the onsite treatment facility. (f) The name and business address of the registered hazardous waste hauler used by the generator to have untreated medical waste removed for treatment. (g) The name and business address of the off site medical waste treatment facility to which the medical waste is being hauled. (h) An emergency action plan complying with regulations adopted by the department. (i) If applicable, the steps taken to categorize the pharmaceutical wastes generated at the facility to ensure that the wastes are properly disposed of as follows: Pharmaceutical wastes classified by the federal Drug Enforcement Agency (DEA) as “controlled substances” are disposed of in compliance with DEA requirements. The name and business address of the hazardous waste hauler used by the generator to have wastes that are not regulated by RCRA waste, safely removed for treatment. (j) A statement certifying that the information provided is complete and accurate

See Medical Waste Management Act, section 117680, 117710, 117950, 117960, 117965 and 117970.

3.4 Home Generators

Home-generated sharps waste means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications derived from a household, including a multifamily residence or household. Medical waste regulations state that a person shall not knowingly place home-generated sharps waste in any container used for the commercial or residential collection of solid waste, recyclable materials, or green waste. Home-generated sharps waste shall be transported in a sharps container and can be managed at any of the following:

• A “home-generated sharps consolidation point”. For a list of all the local “home generated sharps consolidation points” in California, click here.
• A medical waste generator’s facility that accepts home generated sharps waste. A registered medical waste generator, may accept home-generated sharps waste, to be consolidated with the facility’s medical waste stream, subject to all of the following conditions: (a) The generator of the sharps waste, a member of the generator’s family, or a person authorized by the enforcement agency transports the sharps waste to the medical waste generator’s facility. (b) The sharps waste is accepted at a central location at the medical waste generator’s facility. (c) A reference to, and a description of, the actions taken pursuant to this section are included in the facility’s medical waste management plan.
• A facility through the use of a medical waste mail-back container approved by the United States Postal Service.

See Medical Waste Management Act, Section 117671, 117904, 118147 and 118286.

4. Compliance.

4.1 Helpful Links

Below are some helpful medical waste links. Please feel free to contact us with any questions that you may have!

• California Department Of Transportation (DOT)
• California Department of Public Health (CDPH)
• CDPH’s Medical Waste Generator Page
• The Medical Waste Management Act
• California Department of Toxic Substances Control (DTSC)
• California State Board Of Pharmacy
• Drug Enforcement Administration (DEA)
• Federal Department of Agriculture (FDA)