Pharmaceuticals are used for a wide variety of purposes—to help patients recover from illness, treat a disease, manage a chronic condition, etc. Yet even after being prescribed, many drugs go unused. So, understanding how to properly dispose of pharmaceutical waste is vital to any community. It’s also governed by strict, complex, and sometimes confusing regulations.
When mistakes are made and pharmaceutical waste isn’t disposed of properly, there’s a risk of harmful chemicals being released into the environment, which could contaminate water sources (including groundwater) as well as endanger plant, animal, and human life. It can also lead to large fines and negatively impact the good name of an organization.
It’s often tempting to simply wash unused drugs down in a sink or toilet or toss it into the trash, but this can lead to health and environmental concerns in the community. This practice (known as “sewering”) is also federally prohibited, and most states also have stringent regulations banning this practice.
Definition of Pharmaceutical Waste
Any leftover, unused, or expired medication and vaccines that can no longer be used is pharmaceutical waste. As such, it needs to be disposed of properly. Pharmaceutical waste consists of both hazardous and non-hazardous products, depending on the chemical compounds and what risks those may play for humans or the environment.
Pharmaceutical waste also includes contaminated products, such as items needed for the proper handling of pharmaceuticals, including bottles, vials, boxes, tubbing, and PPE like gloves and masks.
Who Regulates Pharmaceutical Waste Disposal?
Pharmaceutical waste can be categorized as either non-hazardous or hazardous waste. If it’s hazardous, it must be disposed of properly through a Hazardous Waste company.
Through the Resource Conservation and Recovery Act (or RCRA, pronounced “rick-rah”), the Environmental Protection Agency (EPA) has been tasked with regulating the disposal of hazardous waste pharmaceuticals. This federal law informs how to classify and properly dispose of various pharmaceuticals. However, states often have additional protections, so it’s important to know state, federal, and local regulations for medical waste disposal.
In addition, the U.S. Department of Transportation (DOT) has other regulations on how to transport pharmaceutical waste. And the U.S. Drug Enforcement Administration is in charge of managing controlled substance waste management. Other government agencies involved in the regulation of the proper disposal of pharmaceutical waste can include the Fish and Wildlife Services (FWS), OSHA, and the Joint Commission.
Depending on the size of the healthcare facility and the volume of pharmaceutical waste it creates as well as the amount of non-acute vs. acute hazardous waste, the regulations also vary.
Categories of Hazardous Pharmaceutical Waste
Three categories of pharmaceutical waste have been defined by the RCRA:
P-list waste is considered acutely hazardous. Pharmaceuticals in this category include a wide range of drugs from warfarin to epinephrine to nicotine and phentermine. This also consists of the containers that have carried P-list medications.
U-list waste is from discarded commercial chemical products and includes sulfuric acid, dimethyl ester, streptozotocin, cyclophosphamide, and many chemotherapy drugs.
A complete list of P-listed and U-listed chemicals can be found here.
Characteristic hazardous waste has one or more of four characteristics that indicate hazardous waste, such as:
- Ignitability, with the flashpoint of below 60˚ C indicating how ignitable the compound is. This can include, for example, some cough syrups and flammable propellants found in aerosols.
- Corrosivity, including acid and bases with a pH less than or equal to 2 or greater than or equal to 12.5, which can corrode steel.
- Reactivity for chemicals that may react with water or heat that then give off toxic gases or detonate.
- Toxicity,for chemicals that are toxic when ingested or absorbed.
The best way to determine how pharmaceutical waste should be treated is to follow the regulations under RCRA. Yet it’s also important to follow state and local regulations and those of specific facilities as well, which may have even more stringent guidelines.
Another way pharmaceutical waste is classified is by regulated medical waste, solid waste, or hazardous waste. This, however, typically depends on the state or locality.
Regardless of how pharmaceutical waste is classified, it needs to be disposed of properly. Even medications that haven’t been classified as hazardous, such as antidepressants, statins, antibiotics, or hormone replacement therapy can be damaging to the health and environment in the community.
How to Manage Pharmaceutical Waste
Disposing of pharmaceutical waste is a priority for any healthcare company, including pharmacies, clinics, hospitals, and more. While the guidelines from federal, state, and local governments can be confusing and strict, there are simple steps to help streamline the process:
- Separate pharmaceutical waste from biohazard waste, placing the biohazard waste in specified red biohazard waste containers.
- Segregate any controlled substances, such as opiates and benzodiazepines, as these must be handled in accordance with DEA regulations.
- Remove chemotherapy waste, even if there are only trace amounts, including empty vials and bottles, IV tubing, and even gloves, and place them in FDA compliant yellow containers. Bulk waste, such as unused medications, are to be treated as hazardous chemical waste.
- Separate hazardous waste, which poses a greater risk to the public, and place them in black containers specified for this purpose.
- Gather what’s left in white containers with blue lids to ensure any remaining pharmaceutical waste is also disposed of according to regulations.
- Finally, contact your preferred licensed pharmaceutical waste disposal service. Ensure your partner is licensed and up to date on all the regulations for your specific area.
123 Compliant Logistics makes your compliance with pharmaceutical waste as easy as 1-2-3. We help healthcare companies consolidate materials from numerous sources, manage the complexities, and ensure compliant handling and destruction. Services include:
- Hazardous pharmaceutical waste
- Large volumes of materials
- Simple rate box programs for those with smaller quantities
- Route services for qualified Arizona customers.
- Direct ship
Simply stated, we take our customers out of the waste management business.
May 1 Annual Inventory
All New Mexico Controlled Substance Registrants are required to conduct an annual inventory of all controlled substances on May 1. This includes doctors, veterinarians and dentists. Now is the time to prepare so your May 1 inventory is a breeze!
Organize your Controlled Substances and Records
- Keep controlled substances separate from other drugs
- Group controlled substances by their NDC (National Drug Code)
- Organize controlled substance logs, purchase invoices, and destruction records
Reduce Inventory Stockpiling
- Remove expired and short-dated controlled substances
- Remove controlled substances you know you will not use
- Don’t order in bulk if you know you won’t use it all before expiration
Send Expired and Unused Controlled Substances for Destruction
- Only send controlled substances to a DEA registered Reverse Distributor
- Ensure you receive a DEA Form 222 for all CIIs BEFORE you ship
- Ensure the destruction company receives the shipment prior to the inventory date **Controlled Substances remain on your inventory while in transit**
123 Compliant Logistics has a budget-friendly, simple rate box destruction.
No contracts required!
Contact us by chat, email or phone. We are here to help!
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Established to honor the men and women who have lost their lives in service of our country,
Memorial Day is a time to reflect and say thank you for the sacrifices that have enabled the freedoms and opportunities this great nation provides. This year, the reflections of those sacrifices, and the freedoms and opportunities, have never been more important.
The team at 123 Compliance Logistics wishes everyone in this great land of the free and home of the brave a safe, happy and healthy Memorial Day Weekend.
DEA Exception for CI-II Order Forms
The Drug Enforcement Administration (DEA) has granted an exception to 21 CFR 1305.13 which requires the original paper DEA Form 222 to be sent your supplier. As you know, the DEA regulations require the supplier of schedule I-II controlled substances receive the physical DEA Form 222 before they are able to ship your order. Due to the public health emergency declared by the Secretary of Health and Human Services (Secretary of HHS), the DEA granted an exception of this requirement to ensure adequate supply of schedule I-II controlled substances during this public health emergency.
The exception allows all DEA Registrants who order schedule I-II controlled substances with paper order forms to fax or scan/email a DEA Form 222 to their supplier. When the supplier receives the faxed or emailed DEA Form 222, they shall treat it as the original and complete their respective fields as they would on the original. This exception will remain in place through the duration of the public health emergency.
Once the Secretary of HHS has ended the state of emergency, the original DEA Form 222 must be sent to the supplier. The supplier is required to attach the original with the faxed or emailed copy and maintain with their usual CI-II records. 123 Compliant Logistics also recommends keeping a copy of the DEA Exception Letter with your faxed or emailed DEA Form 222. A copy of the official DEA Exception Letter can be found here.
Because of the overwhelming fast pace essential workers have had to maintain, it’s important to regularly remove expired or damaged pharmaceuticals from stock shelves to prevent unnecessary errors.
Accelerating the Process
This DEA exception allows 123 Compliant Logistics to quickly issue a DEA Form 222 and authorize shipment of CII, CIII-V and non-controlled pharmaceuticals – all in one email or fax. We have easy-to-use, no contract destruction options for large and small quantities.
Contact us by chat, email or phone. We are here to help!
AZ Emergency Statutes
Every year on May 1st, Arizona pharmacies are required to complete an inventory of all controlled substances on hand. The Arizona State Board of Pharmacy (ASBP) has offered an alternate annual inventory day of September 1st to help alleviate the additional strain of conducting an inventory. Arizona pharmacies may also submit a request to their ASBP Compliance Officer for an alternate day of their choosing. ASBP has published this and other emergency statutes and rules here and will continue to update this document regularly.
Why Annual Inventory is Important
With the insurmountable stress the COVID-19 pandemic has put on the healthcare industry, ensuring continued operation of pharmacies is more important than ever. An annual inventory is essential during this demanding time. It’s mandate has been put in place to prevent diversion and ensure adequate, uninterrupted supply of pharmaceuticals to the communities we serve.
We Can Help
Destruction of your expired, short-dated, and damaged pharmaceuticals before your annual inventory will keep your work load to a minimum. 123 Compliant Logistics is Arizona’s only DEA registered Reverse Distributor. We have programs for large and small quantities. We also offer pick-up service for qualified customers.
Contact us by Phone, Email or Chat. We are here to help!
It’s that time again to conduct State Board of Pharmacy Required Annual Inventory here in Arizona. We’re ready to take all your excess material so you don’t have it on May 1st. As Arizona’s only DEA Reverse Distributor, we offer pickup service
and are eager to help you get your inventory in great shape! If you need to change your annual inventory date to September contact your ASBP Compliance Officer.
Reach out today (602) 612.4140 or chat with us online
Q: Should medical waste or general waste from healthcare facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?
A: Medical waste (trash) coming from healthcare facilities treating COVID-2019 patients is no different than waste coming from facilities without COVID-19 patients. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures. There is no evidence to suggest that facility waste needs any additional disinfection.
More guidance about environmental infection control is available in section 7 of CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed COVID-19 or Persons Under Investigation for COVID-19 in Healthcare Settings.
As we learn more about COVID-19 and its impact continues to evolve and develop, we remain focused on the health and safety of our team members, clients, and our communities.
We understand that some of our clients may experience additional burdens and even hardships as a result of COVID-19. We are committed to supporting you, working hard to ensure our team can continue to provide uninterrupted and dependable pharmaceutical destruction services.
As always we appreciate and thank you for the opportunity to be of service to you. We will continue to monitor the situation and stay focused on keeping our employees healthy while providing you the support you need. We will post updates on our blog so, please subscribe to ensure you stay in the loop.