SOP for Storing Study Drugs and Supplies

Physical Storage Control
The storage area for experimental study drug meets 21 CFR 1301.75. Click here

21 CFR 1301.75 says:

1. Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
  
2. Controlled substances listed in Schedules II, III (our Patch), IV, and V shall be stored securely locked, substantially constructed cabinet. However, pharmacies and institutional practioneers may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
3. This section shall also apply to nonpractioners authorized to conduct research or chemical analysis under another registration.
 
4. Carfentanil etorphinne HCL and diprenorphine shall be stored in a safe or steel cabinet equivalent to a US Government Class V security container.
 

Our office is located on the campus of Jupiter Medical Center which is patrolled by Hospital security night and day. The building and the elevator are locked at night. Our office is alarmed. The study drug is located in an office room that itself has a lock on the door. This office is of limited access and closely guarded by us. We had custom built a very nice secure system to store the study drug. There is a locked cabinet bolted to the wall that is locked. Inside the cabinet there is another locked cabinet that is also bolted to the wall. This is how we meet the criteria double-locked, sequestered, limited access.