Current through September 17, 2024
All wholesale drug distributors must meet the requirements in
21 CFR Part 205 and the following standards for engaging in wholesale drug
distribution.
005.01
PERSONNEL. A wholesale drug distributor must employ
staff to operate the wholesale drug distribution facility under this chapter
and must designate a representative to be in charge of wholesale drug
distribution and the storage and handling of all drugs. Such designated
representative must:
(A) Have knowledge of
federal and state statutes applicable to wholesale drug distribution;
(B) Have had no convictions under any
federal, state, or local laws relating to drug samples, wholesale or retail
drug distribution, or distribution of controlled substances;
(C) Have a minimum of 2 years of verifiable
full-time managerial or supervisory experience in a pharmacy or wholesale drug
distributor licensed in this state or another state, where the designated
representative's responsibilities included but were not limited to
recordkeeping, storage, and shipment of prescription drugs; and
(D) Be actively involved in and aware of the
actual daily operations of the wholesale drug distributor, including the
following:
(i) Employed full-time in a
managerial position by the wholesale drug distributor;
(ii) Physically present at the wholesale drug
distributor during normal business hours, except for time periods when absent
due to illness, family illness or death, scheduled vacation, or other
authorized absence; and
(iii) Aware
of, and knowledgeable about, all policies and procedures pertaining to the
operations of the wholesale drug distributor.
005.02
FACILITY. All
Wholesale Drug Distributor facilities at which prescription drugs are received,
stored, warehoused, handled, held, offered, marketed, displayed, or transported
from must meet the requirements of
21 CFR §
205.50 and the following:
(A) Be a commercial location and not a
personal dwelling or residence;
(B)
Provide for the secure and confidential storage of information with restricted
access and policies and procedures to protect the integrity and confidentiality
of the information;
(C) Provide and
maintain appropriate inventory controls in order to detect and document any
theft, counterfeiting, or diversion of prescription drugs; and
(D) Provide to another wholesale drug
distributor or pharmacy pedigrees for prescription drugs that leave the normal
distribution chain before wholesale drug distribution to such other wholesale
drug distributor or pharmacy in accordance with this chapter.
005.03
PEDIGREES. Each licensee must meet the requirements of
Neb. Rev. Stat. §
71-7456 and
21 CFR §
205.50.
005.04
RECORDS. Each
licensee must meet the requirements of Neb. Rev. Stat. §§
71-7455 to
71-7456,
21 CFR §
205.50, and the following:
(A) Wholesale drug distributors and
manufacturers must maintain an ongoing list of persons with whom they do
business to sell or purchase prescription drugs;
(B) All facilities must establish and
maintain procedures for reporting counterfeit and contraband, or suspected
counterfeit and contraband drugs or counterfeiting and contraband or suspected
counterfeiting and contraband activities to the Department and Food and Drug
Administration (FDA);
(C) Wholesale
drug distributors must maintain a system for the mandatory reporting of
significant shortages or losses of prescription drugs where it is known or
suspected that diversion is occurring to the Department and the Food and Drug
Administration (FDA), and, where applicable, to the Drug Enforcement
Administration (DEA);
(D) Records
must be maintained by the wholesale drug distributor to document all purchases,
sales, destruction, transfer, loss, and return of drugs; and
(E) Records may be kept manually or by
electronic or automated means. When an automated recordkeeping system is used,
there must be a complete back-up system every 7 days that is verifiable to
prevent loss of records.
