In any industry, there are required rules and regulations to ensure the safety and well-being of the people and places involved in managing that industry. Regulations for handling of pharmaceutical drugs and hazardous waste are no exception. Within the pharmaceutical industry, regulations are in place to ensure the proper manufacturing, distribution, dosage, management, and redistribution are in place to regulate and support the safety of today’s communities as well as generations into the future.
Working with An Approved Reverse Distributor
Working with a reverse distributor who routinely evaluates and refines their organization’s intake, security and management processes helps ensure returned products, including hazardous waste, are getting properly returned or destroyed according to EPA regulations.
The EPA defines a solid waste as a hazardous waste if it is specifically listed as a known hazardous waste or exhibits any one of the following characteristic properties: ignitability, corrosivity, reactivity or toxicity.
Since “all controlled substances are to be destroyed by a registrant or caused to be destroyed by a registrant pursuant to §1317.95(c),” materials need to be destroyed in compliance with applicable Federal, State, tribal, and local laws and regulations.
Record Keeping and Proper Forms Management
Record keeping and proper management of forms is also a tremendous part of safety and compliance in the redistribution process. When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form 222) or the electronic equivalent to the pharmacy.
Keeping accurate records not only ensures you are in compliance with state and federal regulations, it can also save you thousands of dollars in return credits for properly returned and processed products.
Knowing which forms are required by the US Department of Justice for returning and destruction of pharmaceuticals ensures a more secure, more efficient process for pharmacies, doctors’ offices and other approved pharmaceutical distributors.
At National Pharmaceutical Returns we can help answer any questions you have about the packaging, shipping and management of returnable products. Feel free to give us a call at 800-470-7725, or contact our partners at PharmWaste Technologies for Drug Waste Consulting services at 515-276-5302.