Medical research laboratories often use controlled substances and many different pharmaceuticals during the course of research. The Environmental Protection Agency (EPA) and the Drug Enforcement Administration (DEA) regulate safe and compliant medication waste. The DEA has issued Code of Federal Regulations DEA 21 CFR related to compliance of medication disposal and the EPA has issued EPA 40 CFR regarding the regulations for the protection of the environment. These federal regulations apply to pharmaceutical waste generated from any industry and include controlled substances from medical research facilities.
Controlled substances should be destroyed properly when they are no longer required for laboratory research projects or if they become unwanted or expired. Medication waste should also be disposed of when a research project is completed or terminated and the drugs are still in inventory. Controlled substance waste must also be destroyed when a controlled substance use authorization (CSUA) expires and is not renewed or when a DEA registrant terminates employment.
Medical Research FDA Procedures Regarding Sample Management
The Office of Regulatory Affairs, ORA Laboratory Manual, Volume II, ORA.LAB.5.8 Sample Management, includes the regulations for the chain of custody and sample handling as enforced by FDA federal procedures. The manual includes operating procedures and work instructions for sample receiving, storage, protection, handling, shipping, and disposal of pharmaceuticals used in laboratories including controlled substances used in medical research facilities.
A tracking system known as the Field Accomplishments Compliance Tracking System (FACTS) is an automated system useful in the compliant tracking and reporting of samples. This automated, centralized system gathers and compiles data into a nationwide system and requires that all controlled substance samples be entered into FACTS before arrival at the medical research facility. Medical research laboratory areas which are deemed as being controlled spaces that require measures to protect the safety and integrity include areas such as:
- Sample storage areas
- Drug storage areas and vaults
- Solvent storage areas
- Radioactive materials storage
- Storage of infectious materials
- Sterility testing area
- Storage of alcohol
- PCR areas
Drugs that are on the controlled substance list as Schedule I or II drugs require correct handling and disposal as required in 21 CFR 1308, which includes the current revisions for the correct controls, handling and disposal of pharmaceuticals in medical research.
Medical Research CS Waste Disposal Product Solutions
C2R Global Manufacturing offers controlled substance waste disposal solutions for medications used in various facilities and environments including medical research laboratories. Rx Destroyer™ is a safe and easy to use drug disposal product available in various sizes to meet the needs of any facility generating pharmaceutical waste. With a patented solution that begins to neutralize medications on contact, Rx Destroyer™ meets the requirements of DEA approved chemical digestion for the destruction of leftover, unused or expired medications.
C2R Global Manufacturing offers safe and compliant drug disposal products along with mail back options and waste hauler assistance. Our trusted partner, GTC Consulting, provides DEA compliance consultations to ensure compliance to DEA federal regulations regarding pharmaceutical waste disposal. Contact us to learn more about Rx Destroyer™ and solutions for medication waste in medical research laboratories.