Pharmaceutical Waste Regulation Compliance
BioServ understands that managing pharmaceutical waste can be especially challenging due to the complexity of the regulations that govern activity and the multiple regulatory agencies that oversee it. Most people are not aware that there is in fact a minimum of 7 different agencies overseeing the proper management of pharmaceuticals:
- Environmental Protection Agency (EPA)
- Department of Transportation (DOT)
- Drug Enforcement Agency (DEA)
- Occupational Safety and Health Administration (OSHA)
- State Environmental Agencies
- State Pharmacy Boards
- Local Publicly Owned Treatment Works (POTW)
BioServ will work with you to ensure you are in compliance with all agency standards. It is important to keep in mind that the RCRA regulations (the laws that govern chemical waste) were written with the industrial waste generation in mind, not for finished pharmaceutical forms such as tablets, capsules, and injectables. In addition, the pharmaceutical industry develops new drugs faster than the federal EPA can categorize them. BioServ makes it a priority to stay up-to-date with ever-changing federal and state regulations. We take special care to ensure your pharmaceutical waste management practices stay in compliance so you can focus on what’s important—your business.
The first step to achieving a high level of compliance is instituting some simple but very necessary work practices and procedures. Reviewing the applicable state and federal regulations is the best place to start.
A Summary of the “Must-Do” Practices:
- Designate a waste storage area. Choose a dry, well-lit area with as little pass-by traffic as possible. Proper signage must be posted designating it a waste storage area. Proper labeling must be attached to all waste containers. (BioServ will provide you with the necessary materials.)
- Only use UN/DOT approved waste receptacles. The correct containers can be provided by BioServ and will come with proper labels.
- Wear proper Personal Protective Equipment (PPE) at all times when handling pharmaceutical waste. Gloves should be worn when handling all chemicals. Protective eyewear should be worn when handling liquid medications as well as a long-sleeved shirt or coat to prevent contact with the skin.
- Detach sharps and place them in their proper sharps container when disposing of expired or unused IV bags.
- Maintain Safety Data Sheets (SDS) for all pharmaceuticals which are regularly handled/dispensed by your clinical staff, as required by the OSHA hazardous communication standard. These records are to be kept for thirty (30) years, even after the use of the pharmaceuticals has been discontinued.
- Save all waste manifests for a minimum of three (3) years.
- NEVER discard pharmaceuticals in any receptacle other than the one assigned to it. Never place pharmaceuticals in your regulated medical waste receptacle, regular garbage bin, down the sink or down the toilet. Dispose of the pharmaceuticals in the proper receptacle that has been previously assigned by BioServ. This will ensure proper DOT segregation.