Why PAC-RX™

TRUTH IN ADVERTISING – Medicine Disposal Devices

PAC-RX™ believes in a code of ethics that promotes truth in advertising. Simply put, you will not see any unsupported claims in order to sell more product. There are several choices available in today’s market for proper pharmaceutical waste disposal. We would like to showcase the PAC-RX™ device while also clearing up some of the misconceptions surrounding medicine disposal device marketing claims and the regulatory agencies stance on them, in particular DEA and EPA.

JUST THE FACTS – Medicine Disposal Devices

Here is a closer look at the facts surrounding standalone medicine disposal devices that many healthcare institutions and organizations are currently using. Although features, mechanisms of function and cost may vary between devices, they essentially are designed to make DEA controlled substances less accessible to the public or workers.

• DEA has a written non-retrievable standard which if met, prevents a controlled substance to be retrieved and reused. 21 CFR Part 1300
• DEA has the ability and authority to approve technologies to meet their non-retrievable standard. They however, will not endorse a particular product or brand.
• Contrary to some vendor claims, DEA does not concur with any medicine disposal standalone device marketing claims to meet DEA’s non-retrievable standard.
• To date, DEA has not approved any third party standalone disposal device technology to meet DEA’s non-retrievable standard.
• To date, DEA has approved thermal destruction (incineration) as a technology that meets DEA’s non-retrievable standard.
• Activated carbon is the active ingredient most widely used in standalone medicine disposal devices, including PAC-RX™.
• Contrary to some vendor claims, studies have shown that medicine adsorbed by activated carbon can later be extracted and therefore does not meet DEA’s non-retrievable standard.
• Contrary to some vendor claims, usage of a standalone medicine disposal device does not render a RCRA hazardous waste drug, non-hazardous. In fact, it may have quite the opposite effect and create more hazardous waste.
• EPA concurs with DEA’s position that 3rd party medicine disposal devices do not meet DEA’s non-retrievable standard, until such time DEA changes their stance and puts it in writing.

We encourage you to contact your DEA division to verify these statements. DEA divisions We encourage you to contact your regional EPA to verify these statement; EPA regions The above statements are monitored and will be modified if the DEA’s and EPA’s regulatory stance changes.

So where do we go from here?

Standalone medicine disposal devices, although they may not meet DEA’s non-retrievable standard still do serve a valuable and meaningful purpose, in particularly if coupled with thermal destruction (incineration).

Role of Medicine Disposal Devices – DEA Sequestration Devices

• Excellent security measure for DEA Pharmaceutical Wastage.
• Recommended procedure:
  1. Place DEA Pharmaceutical Wastage in device per instructions.
  2. When full, incinerate device in appropriate incinerator.
  3. DO NOT place MDD’s in the regular trash as they will likely contain RCRA hazardous waste.

State Issues

When it comes to disposal of pharmaceutical waste, states may have additional regulations that apply. It is imperative that you are familiar with those state and local regulations for compliance.