by PL

From The Backyard Pharmacy®: During the Nichopoulos trial, Tish Henley testified, “that she had been in charge of the drugs at Graceland since 1975 and kept them in an overnight bag under lock and key in her trailer.” [“The Death of Elvis,” pg. 303]

Here are several pertinent sections from the DEA Controlled Substance Secure Storage requirements (“Security Requirements”) effective in 1977 for the proper storage of Schedule II and Schedule III drugs. Nowhere in these guidelines will you find mention of “an overnight bag under lock and key.” The full overview is here.

  • General storage rule
    • All controlled substances must be stored behind at least two differently keyed locks at all times.
    • For keyed lockboxes
      • Do not store the keys near the lockbox; and
      • Do not store the keys together.
    • For combination lock lockboxes
      • Only the registrant and as few responsible individuals as possible should know the combination.
      • Whenever anyone who knows the combination is terminated from employment, the combination(s) must be changed.
  • Schedule I and II substances
    • Must be stored in a safe or steel cabinet of substantial construction. 
      • If the safe or cabinet is less than 750 lbs., it must be mounted or secured to something of substantial construction (e.g., bolted to a wall or the floor, or the base imbedded in concrete).
      • The safe/cabinet should have an inner and outer door with the locks for each door keyed differently.
  • Schedule III, IV, and V controlled substances
    • Should be stored using one of the following methods:
      • Preferred method: a wall mountable controlled substance lockbox with two doors and two locks (each lock is keyed differently). 
      • A single-lock lockbox that is stored in a drawer or cabinet that is secured at all times with a hasp [seen below] and padlock.  The drawer and cabinet should be substantially constructed such as in a drawer that is part of either a bench or cabinet that is mounted to the wall or floor.
      • If a lab is not accessible to the public, then an option is to use a single-lock lockbox, stored in a drawer or cabinet in a room that is kept locked at all times.
      • Schedule III, IV and V substances can also be stored with Schedule I and II substances.

Additionally, for Schedule II and Schedule III drugs, from Title 21 CFR, §1301.72 (a) (3):

(iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve, and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;

(v) The door of which vault is equipped with contact switches; and

(vi) Which vault has one of the following: Complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Administration.

And finally, from Title 21 CFR, §1301.72 (d):

(d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

Were any of these security requirements in place at the The Backyard Pharmacy®?

Note: If the drugs were stored according to the legal requirements, the “overnight bag” would not have even been mentioned.