175 Neb. Admin. Code, ch. 8, § 006

Current through September 17, 2024

Section 175-8-006 - STANDARDS FOR THE OPERATION OF A PHARMACY

The licensee must comply with the Prescription Drug Safety Act, the Pharmacy Practice Act, the Controlled Substances Act, and the following:

006.01STAFFING. Each licensee must have a pharmacist in charge or practitioner with the qualifications, training, and skills necessary to meet the requirements according to this chapter.

006.01(A)LICENSED PHARMACIST. Each licensee must employ a sufficient number of licensed pharmacists to meet the needs of the individuals seeking services at the pharmacy.

006.02STORAGE REQUIREMENTS. All drugs, medical devices, and biologicals must be stored in a manner that meets the manufacturer's labeled requirements or those listed in this chapter.

006.02(A)TEMPERATURE AND LABEL REQUIREMENTS. The licensee must provide equipment for the storage of drugs, devices, and biologicals at the proper temperature:

(i) Drugs, devices, or biologicals requiring refrigeration must be stored between 36 and 46 degrees Fahrenheit;

(ii) Drugs, devices, or biologicals requiring a freezer must be stored between -13 and 14 degrees Fahrenheit;

(1) For drugs, devices, or biologicals requiring a storage temp under -4 degrees Fahrenheit the temperature of the storage location must be within plus or minus 10 degrees;

(iii) Drugs, devices, or biologicals requiring storage in a cool place must be stored between 46 and 59 degrees Fahrenheit, or under refrigeration, between 36 and 46 degrees Fahrenheit, unless otherwise specified;

(iv) Drugs, devices, or biologicals requiring storage at controlled room temperature must be stored between 68 and 77 degrees Fahrenheit; and

(v) Other labeled storage instruction for drugs, devices, or biologicals must be followed.

006.02(B)SEPARATE STORAGE. Drugs, devices, and biologicals, dietary supplements or substances used in compounding cannot be stored in the same refrigerator as food.

006.02(C)MISBRANDED OR ADULTERATED DRUG STORAGE. All drugs which are misbranded or adulterated shall not be stored with saleable inventory.

175 Neb. Admin. Code, ch. 8, § 006

Amended effective 11/3/2020