059-3 Wyo. Code R. § 3-27

Current through April 27, 2019
Section 3-27 - Other Security Controls for Nonpractitioners

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Drug Enforcement Administration or with the Wyoming State Board of Pharmacy, to determine that the person is registered to possess the controlled substance.

(b) The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Board and the Drug Enforcement Administration of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

(c) The registrant shall notify the Drug Enforcement Administration and the Board of any theft or significant loss of any controlled substances upon discovery of such theft or loss. The registrant shall also complete an inventory regarding such theft or loss and submit a copy of such inventory to the Board. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) Distribution of Controlled Substance Samples.

  • (i) The registrant shall not distribute any controlled substance listed in Schedule II or III as a complimentary sample to any potential or current customer or patient except in the following manner:
    • (A) Manufacturers/distributors of samples of controlled substance pharmaceutical products must be registered with the Board of Pharmacy and Drug Enforcement Administration before shipping controlled substances into the State of Wyoming.
    • (B) Manufacturers/distributors shall send to the Wyoming Board of Pharmacy a record of all such transactions involving the shipment of samples to a Wyoming registrant. The Board shall be notified of any unreasonable order requests or records shall be sent upon request. Records kept and provided by the manufacturer/distributor shall include:
      • (I) Manufacturer/Distributor name and DEA registration number.
      • (II) Address of Manufacturer/Distributor.
      • (III) Name, address and registration (DEA#) number of registrant receiving samples.
      • (IV) Drug name, strength, quantity/package, quantity/number of packages - total quantity sent to registrant.
      • (V) Date of shipment or delivery to the registrant.
  • (ii) Registrants (practitioners) requesting controlled substance samples shall do so in the following manner:
    • (A) Registrant (or agent) must sign for samples upon receipt.
    • (B) Retain the invoice of controlled substances samples received.
    • (C) Records must be kept of all samples dispensed or administered. The registrant's office record shall include: date of dispensing or administering; patient name; drug sample name; strength; quantity given (total number of tablets or volume of liquid); initial of practitioner or agent.
    • (D) Registrant shall personally sign or initial records of samples dispensed or administered at the bottom of each page on a regular basis.
    • (E) Make such records available to the Wyoming State Board of Pharmacy inspector or Drug Enforcement Administration agent upon request.
  • (iii) Samples of controlled substances listed in Schedule IV and V are exempted from requirements further than those imposed by the Drug Enforcement Administration for distribution in the State of Wyoming.

059-3 Wyo. Code R. § 3-27