Current through September 17, 2024
Inspections must meet the requirements set out in Neb. Rev.
Stat. §§
71-7453 to
71-7456, and this chapter.
004.01
TRIENNIAL
INSPECTION. On a triennial basis after initial licensure, all
wholesale drug distributor facilities must be inspected. The licensee must
ensure that:
(1) The designated representative
is present at the facility at the time of inspection;
(2) All records which describe the wholesale
drug distribution activities for the triennium are accessible during the
inspection, including drug analysis; and
(3) Any required fees for conducting the
inspection are paid.
004.01(A)
INSPECTION BY OTHER ENTITY. If the inspection is
performed by a nationally recognized accreditation program approved by the
Board or by another state or federal regulatory agency approved by the Board,
the inspection must meet the requirements in this chapter, including standards
for:
(i) Personnel;
(ii) Facility;
(iii) Pedigrees;
(iv) Policies and procedures; and
(v) Records.
004.02
INSPECTION FOR
CAUSE. The Department may inspect a wholesale drug distributor to
determine violations when any 1 or more of the following conditions or
circumstances occur:
(A) An accident or
natural disaster resulting in damage to the facility or interruption of utility
services which could result in adverse effects to the potency, efficacy, safety
or security of the prescription drugs;
(B) A complaint alleging violation of the
Wholesale Drug Distributor Licensing Act or these regulations;
(C) A complaint that raises concern about the
maintenance, operation, or management of the facility;
(D) Change of scope or type of services
offered, management or location;
(E) Change in the designated representative;
and
(F) Any other event that raises
concerns about the maintenance, operation, or management of the
facility.
004.03
SUCCESSFUL COMPLETION OF INSPECTION. Each applicant
for a wholesale drug distributor license must successfully complete an
inspection to receive a wholesale drug distributor license and to retain such
license by demonstrating compliance with the standards found in Section 005 of
this chapter.
004.04
FAILED INITIAL INSPECTION. When an applicant of a
wholesale drug distributor license does not meet all of the inspection
standards and receives a rating of "Fail" on the initial inspection, the
applicant:
(A) Must not open the wholesale
drug distribution facility;
(B)
Must pay the re-inspection fee; and
(C) Must be subject to a re-inspection within
90 days after failing the initial inspection to determine if the applicant
meets the requirements.
004.05
FAILED TRIENNIAL
INSPECTION. When a licensee does not meet all of the inspection
standards and receives a rating of "Fail" on a triennial inspection, the
licensee:
(A) Will be granted up to 90 days
from the date of the triennial inspection to meet the requirements.
(B) Must pay the re-inspection fee;
and
(C) Must be subject to a
re-inspection within 90 days after failing the triennial inspection to
determine if the licensee meets the requirements.
