172 Neb. Admin. Code, ch. 131, § 004

Current through June 17, 2024

Section 172-131-004 - INSPECTIONS

Inspections must meet the requirements set out in Neb. Rev. Stat. §§ 71-7453 to 71-7456, and this chapter.

004.01TRIENNIAL 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.

004.02INSPECTION 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.

004.03SUCCESSFUL 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.

004.04FAILED 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.

004.05FAILED 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.

172 Neb. Admin. Code, ch. 131, § 004

Amended effective 9/20/2023