Permits: Drug Manufacturing

Permit to Operate

All persons intending to operate a Drug Manufacturing facility in Nevada, must obtain a permit from the Division of Public and Behavioral Health, Environmental Health Section. A drug is any component ingredient used in the manufacture of drugs, in dosage form, whether or not the ingredient appears in the finished product. The term includes amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers.

    Supplemental Application

    All persons intending to operate a Drug Manufacturing facility must submit a Supplemental Application. This application collects information specific to the facility type.

      Permit Requirements

      • Permit to Operate
      • Supplemental Applicaiton
      • The applicant must provide the Commissioner with complete information regarding ownership and must report promptly all significant changes in ownership. If the applicant is a publicly held corporation, only the information regarding the person holding a majority interest need be so provided.
      • A corporate applicant must provide the Commissioner with the name and address of each of its officers, directors and managers. An applicant who is not a corporation must provide the Commissioner with the name and address of each of his or her managerial employees. An applicant shall notify the Commissioner of any change in this information.
      • An applicant must state the proposed hours of operation of the plant. The applicant shall notify the Commissioner of any change in the hours of operation.

      Plan Review Requirements

      The plans must include, but is not limited to:

      • The layout and arrangement of the plant;
      • The materials to be used in construction; and
      • The location, size and type of any fixed equipment and facilities; and
      • The formula for the drug, including all its components; and
      • The procedures to be used in processing the drug.

      The Commissioner’s approval of a plan does not constitute his or her final approval of the facility. An actual inspection of the completed facility must be made before a final approval will be given to the applicant. Until such inspection is made and final approval of the facility is granted, the Commissioner will not issue a license.

        Fees

        • $2000 Initial licensing fee and renewal fees
        • $30,000 Initial licensing fee and renewal fees of drugs with amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers

        Payment of Fees

        The permit fee(s) must be paid using the on-line system (CLICS). The on-line system requires an e-check or credit card. If unable to use the on-line system, the accepted payment types include, check or money order. Please make payable to the Division of Public and Behavioral Health EHS. Fees paid will not be refunded for failure to obtain final approval or voluntary withdrawal.