Pharmaceutical Waste Management

Responsibly managing your waste pharmaceuticals is of critical importance. If not properly disposed of, their impact on the environment on a global level will be irreversible. While we cannot prevent individuals from throwing their waste medications in the trash, we as a healthcare community can work together to create an environment of accountability and sustainability within our industry.

Pharmaceutical waste regulations have been in place for many years now, and they are forever changing. However, at Approved, we understand that for many, this is a new subject and uncharted territory. With this in mind, we have made every effort to make our Pharmaceutical Waste Management Program as user-friendly as possible. Our experts will work with you to determine your specific needs and implement a cost-effective customized pharmaceutical waste management program. Services are provided on an “on-demand” or automatic basis, but we charge only upfront unit pricing, with no fixed monthly costs or hidden fees.

Pharmaceuticals can most easily be broken into 3 primary categories: RCRA Hazardous waste, State Regulated Non-Hazardous Waste, and DEA Controlled Substances.

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Non-Hazardous Pharmaceutical Waste

For most facilities, greater than 90% of your pharmaceutical waste will be non-hazardous pharmaceutical waste. Now non-hazardous doesn’t mean it’s just trash- in industry terms, it just means that it is state-regulated versus federally-regulated. However, this is good news for two reasons. First, it makes segregating your waste much easier. Second, average disposal costs are significantly decreased for non-hazardous pharmaceutical waste.

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Examples of Non-Hazardous Pharmaceuticals

  • OTC Medications
  • Non-DEA Controlled/Non-RCRA Hazardous Prescription Medications
  • Hormones
  • Allergy Medications
  • Ointment/Cream medications
  • Vitamins & Supplements
  • Most Vaccines
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RCRA Hazardous Pharmaceutical Waste

The next and most regulated category of waste is federally regulated RCRA Hazardous pharmaceutical waste and DOT Hazardous materials. RCRA stands for Research Conservation & Recovery Act. This is the set of federal laws that govern hazardous waste management at a national level and are enforced by the EPA.

DOT stands for the Department of Transportation. They too have a list of pharmaceuticals they consider hazardous materials but some do not appear on the RCRA list.

Fortunately, there are only a relative handful of medications on the federal RCRA list or the Department of Transportation’s (DOT) table of hazardous materials. To simplify it even further for most, many of the listed items are only used by specialized facilities like hospitals or pharmacies.

At Approved, regardless of size, we will implement a simple, easy to follow program that fits the needs of your facility.

Examples of U & D Listed RCRA Hazardous Waste Pharmaceuticals

  • Cyclophosphamide
  • Mitomycin
  • Insulin
  • Phenol
  • Selenium Sulfide
  • Mercury & Silver containing medications
  • Lindane

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Examples of P-LISTED RCRA Hazardous Waste Pharmaceuticals

  • Coumadin/Warfarin
  • Nicotine (Deregulated in several states, consult with one of our experts)
  • Epinephrine & Nitroglycerin (CT only)

Your specific circumstances and the amount of waste you generate will ultimately determine your generator status and the number of containers you will need on-site. Many facilities will be able to combine these two sub-categories.

Examples of RCRA Hazardous AEROSOL Waste Pharmaceuticals

All Aerosols and Inhalers fall under this category. Please note that an aerosol will always be in a pressurized metal canister. If it is a plastic inhalation device, it can be managed as non-hazardous pharmaceutical waste. Other examples include:

  • Albuterol rescue inhalers
  • Symbicort
  • Ethyl Chloride
  • Atrovent
  • Dermoplast

Upon implementation, ASWH will provide all required, properly labeled DOT approved waste collection containers. At the time of disposal, one of our technicians will ensure that your waste is properly packaged and provide a waste tracking manifest for your records. Replacement containers will be provided by ASWH as needed.

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New EPA Final Rule on Pharmaceutical Waste Management

CFR 49 Part 266 Sub-part P

On August 21, 2019, The Federal Environmental Protection Agency enacted a new final rule pertaining to pharmaceutical waste management and disposal. If your facility generates pharmaceutical waste, the new regulations, CFR 49 Part 266 Subpart P, will likely affect your operations if they have not done so already.

Under the new regulations, an immediate nationwide ban on sewering or flushing hazardous pharmaceuticals is now in effect. It is of the utmost importance to ensure that you are prepared to comply with all the new regulations.

Depending on your state’s individual government structure, a state has until July 2021 or July 2022 to adopt the entire set of new regulations. However, these regulations are not optional- states must adopt the new regulations because they are more stringent. A state can only choose to opt-out of less stringent regulations. Many states have immediately adopted the new regulations.

New Requirements for Healthcare Facilities Under Part 266 Subpart P

  1. Healthcare facilities will need to determine their hazardous waste generator status.
  2. Provide a one-time notification to the EPA regional administrator.
  3. Properly manage their hazardous pharmaceutical waste going forward.

Benefits of the New Regulations

Hazardous pharmaceuticals will no longer count toward generator status. As a result, many generators will be able to reduce their generator status or, at a minimum, remain a VSQG even if the waste volume increases.

  1. The limitations on shipping P-listed pharmaceuticals like Coumadin will be eliminated as they will no longer count toward generator status. The need for VSQG and SQG generators to segregate the select few P-listed medications is no longer required.
  2. Satellite storage limitations are reduced, made more user-friendly, and made more cost-effective.
  3. Hazardous pharmaceuticals can be stored up to 365 days at the site of the generator regardless of generator status.
  4. Training & Reporting requirements are greatly reduced or eliminated.
  5. OTC Nicotine replacement products are no longer considered hazardous waste and can be discarded as non-hazardous pharmaceutical waste when unused or as regular trash when used.
  6. Medications considered both hazardous and DEA controlled substances are now regulated ONLY as DEA controlled substances.

As a healthcare provider, it is your obligation to comply with all current regulations and any new ones that may arise. At Approved, we stay up to date with changing regulations so you can focus on what’s important- your business. Let us implement a simple and cost-effective pharmaceutical waste management program today so you don’t find yourself in an unfortunate situation with a regulator tomorrow.

Frequently Asked Questions
Do you have any minimum service requirements?

On-demand customers utilize our services as required without a minimum. Automatic clients can adjust their schedule at any time.  

However, under certain circumstances, if the quoted price was based on a specific volume of waste and that volume consistently falls short, then stop minimum may apply. (e.g. quoted price based on 25 boxes per month and client averages 5 boxes per month).

Do you have recurring monthly surcharges or additional fees?

No.

What can go in your medical waste box?

Locked sharps containers and any items contaminated with blood or other potentially infectious materials. Some common items are pads, tubing, gloves, dressings, disposable instruments, etc.

What size is your waste box?

4.5 Cu. Ft. (18x18x24”)
7.0 Cu. Ft.

Where does my waste go when it leaves my facility?

Waste is transported directly from your facility to one of our company-owned and operated licensed treatment facilities. With Approved, there is no subcontracting, so waste goes from your facility to ours for same-day processing.

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At Approved we are committed to our customers and the regions we serve, from creating local jobs in communities that will benefit from them the most to utilizing environmentally sustainable treatment technologies. Since the beginning, a cornerstone of our organization has always been to create a "pathway to success" for all of our employees through training and promoting from within. Rewarding hard work while providing the real world and practical experience necessary to make a profitable lifelong career with our company. For our clients our goal is to be a valued partner, a company you can count on for expert advice, personal attention, premium service and responsible environmental stewardship.
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