Section 172-131-005 - STANDARDS FOR ENGAGING IN WHOLESALE DRUG DISTRIBUTIONAll wholesale drug distributors must meet the requirements in 21 CFR Part 205 and the following standards for engaging in wholesale drug distribution.
005.01PERSONNEL. 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.005.02FACILITY. 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.005.03PEDIGREES. Each licensee must meet the requirements of Neb. Rev. Stat. § 71-7456 and 21 CFR § 205.50.005.04RECORDS. 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.172 Neb. Admin. Code, ch. 131, § 005
Amended effective 9/20/2023