HRS §328-113
Rules for wholesale prescription drug distributors
This section lets the state health department make rules to carry out the law and follow federal guidelines for wholesale prescription drugs. The rules must be at least as strict as federal rules, and if there is a conflict, the stricter rule wins. The department can also adopt storage standards by referring to official drug compendiums.
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The statute, as written — Rules
(a) The department may adopt such rules as may be necessary to carry out the purposes and enforce the provisions of this part and to implement the requirements of 21 Code of Federal Regulations Part 205, including minimum requirements for the storage and handling of wholesale prescription drugs; the keeping of records regarding their receipt and distribution; written policies and procedures for wholesale prescription drug distributors; and the salvaging and reprocessing of prescription drugs. All rules adopted under this part shall meet or exceed the requirements of the wholesale prescription drug distributor guidelines contained in 21 Code of Federal Regulations Part 205, and in case of conflict between any rule adopted under this part and the provisions of 21 Code of Federal Regulations Part 205, the more stringent provision shall prevail. (b) The director may, without regard to chapter 91, adopt standards regarding conditions and temperatures for the storage of prescription drugs by reference to the provisions of an official compendium such as the United States Pharmacopeia/National Formulary (USP/NF), as updated from time to time.
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