172 Neb. Admin. Code, ch. 134, § 006

Current through June 17, 2024

Section 172-134-006 - STANDARDS FOR DISPENSING LEGEND DRUGS AND DEVICES

The requirements for dispensing drugs are set out in the Pharmacy Practice Act, and this chapter.

006.01DELEGATING PHARMACIST. The delegating pharmacist must meet the requirements of Neb. Rev. Stat. § 38-2882 and must report any significant discrepancies in the inventory of the delegated dispensing site to the Board and the administrator of the delegated dispensing site.

006.02PRESCRIPTION REFILL. Refills under Neb. Rev. Stat § 38-2884(3) for contraceptives cannot be authorized for greater than 1 year from the date of issuance of the original prescription.

006.03DISPENSING. Drugs must be dispensed in accordance with Neb. Rev. Stat. § 38-2884.

006.04PACKAGING. All drugs or devices dispensed under a delegated dispensing permit are to be prepackaged by the manufacturer or a pharmacist on-site into the quantity to be prescribed and dispensed at the delegated dispensing site.

006.05CONTAINERS. All new and refilled prescriptions must be packaged in new sanitary containers before they are dispensed; original unopened containers as received from the manufacturer, distributor or packer may be utilized provided the pharmacist ensures all labeling requirements of this chapter are met.

006.06PRESCRIPTION AND PRESCRIBED MEDICAL ARTICLES RETURNS. A delegated dispensing permit holder is prohibited from accepting for any purpose any dispensed prescriptions.

006.07INVENTORY. A pharmacist must ensure that the inventory of all drugs and devices in the delegated dispensing site have affixed to them the original label of the manufacturer, distributor or packer. Information contained on all labels and packages must be complete and accurate. A pharmacist must ensure that the inventory of all drugs in the drug dispensing area have affixed to them a label with the information set out in Neb. Rev. Stat. § 38-2884. Drugs stored in the drug dispensing area or dispensed to patients are deemed misbranded if they are not labeled as specified in Neb. Rev. Stat. § 38-2884 or as set out in Neb. Rev. Stat. § 71-2470.

006.08STORAGE AND ENVIRONMENT. The site, furnishings, and equipment must be maintained in a clean, orderly, and sanitary manner at all times. All drugs and devices must be stored in a manner that meets the recommended storage requirements of the manufacturer or those listed in 175 NAC 8-006.02.

006.09RECORDKEEPING. The delegating pharmacist is responsible for recordkeeping as set out in Neb. Rev. Stat. § 38-2882 and the following:

(A) A delegated dispensing permit holder must maintain a single file of the prescription information;

(B) The delegated dispensing permit holder must maintain records of all drugs and devices dispensed for 5 years;

(C) When an electronic recordkeeping system is used and it becomes inoperable, dispensing transactions occurring during this period of inoperability must be entered into the system when the system becomes operable;

(D) Dispensing records must be readily retrievable;

(E) Appropriate reference material for the practice of pharmacy must be kept; and

(F) A manual of current policies and procedures must be kept and includes the following:

(i) Labeling requirements;

(ii) Storage and security of drugs and devices;

(iii) Proper patient instruction;

(iv) Formulary;

(v) Library resources;

(vi) Record keeping, to include the medical chart;

(vii) Drug recall procedures;

(viii) Policies for licensed or certified health care staff; and

(ix) Policies for public health clinic workers.

006.10REQUIRED SIGNAGE. Each site must display a Poison Control Center phone number in a conspicuous location. Each permit holder must display the permit in a conspicuous manner in the drug dispensing area.

172 Neb. Admin. Code, ch. 134, § 006

Amended effective 9/20/2023