Controlled substances must be properly disposed of when they become expired, unwanted or are no longer required for laboratory or research projects. Pharmaceutical waste must also be disposed of when a project is terminated or closed and controlled substances are still in stock. Other instances when CS waste must be disposed occurs when a DEA registrant terminates employment or when a controlled substance use authorization (CSUA) expires and is not renewed.
FDA Procedures for Sample Management in Medical Research
The Office of Regulatory Affairs, ORA Laboratory Manual, Volume II, ORA.LAB.5.8 Sample Management contains the FDA national procedures for sample management along with work instructions for documenting chain of custody. This manual also includes work instructions for operating procedures such as receiving samples, storing, protecting, opening, handling, shipping and disposition of pharmaceuticals used in laboratories including CS waste in medical research.
The Field Accomplishments Compliance Tracking System (FACTS) is recognized as an automated system by the FDA for sample tracking, timely reporting, tracking field assignments, firm or entity information and compliance actions. This is a centralized automated system which gathers data from the ORA into a nationwide system. The CS sample must be entered into FACTS prior to arriving at the medical research facility.
Areas within the research laboratory are designated as controlled areas and require additional protective measures to ensure safety and integrity. Controlled areas include:
- Drug storage area or vault
- Solvent storage area
- Sample storage area
- Alcohol storage area
- Infectious Materials Room
- Radioactive Material Area
- PCR Room
- Computer room
- Sterility Testing Room
- Document room
Drugs and controlled substances which are designated as a controlled substance under Schedule I or II according to the controlled substance act as amended with 21 Code of Federal Regulations (CFR) 1308.11-12, current revision require the proper controls, handling and disposal when used in medical research laboratories.
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