Licensing of persons manufacturing, compounding, processing or packaging drugs, devices or cosmetics: Regulations
1.The Commissioner shall adopt regulations for the licensing of every person who manufactures, compounds, processes or packages drugs, devices or cosmetics in a factory, warehouse, laboratory or other location in this State. The regulations must set forth the requirements for issuance and renewal of a license. Only a person who complies with the requirements of this chapter is entitled to a license. A license is not transferable from person to person or from place to place. The regulations must prescribe the length of term for which a license is issued and must set forth grounds and procedures for the revocation, suspension or nonrenewal of a license.
2.A valid license is required for the manufacturing, compounding, processing or packaging of drugs, devices or cosmetics in any factory, warehouse, laboratory or other location in this State. Licensed pharmacies compounding or packaging prescriptions are exempt from this provision.
3.The Commissioner shall establish and collect fees for the purpose of paying the costs of inspecting, testing and other functions required under the provisions of this chapter with respect to any drug, device or cosmetic. Failure to pay any fee imposed pursuant to this subsection is a ground for revocation, suspension or nonrenewal of a license. All such fees collected by the Commissioner must be deposited with the State Treasurer for credit to the State General Fund.
4.As a condition for entertaining the application of any applicant for any license authorized under this chapter, and as a further condition for the issuance of any such license, the Commissioner or the Commissioner’s authorized agent is entitled to free access at all reasonable hours to any factory, warehouse or other location in which drugs, devices or cosmetics are manufactured, compounded, processed or packaged or held for introduction into commerce, and may enter any vehicle being used to transport or hold such drugs, devices or cosmetics in commerce, for the purposes of:
(a)Inspecting the factory, warehouse, other location or vehicle to determine whether any of the provisions of this chapter is being violated; and
(b)Securing samples or specimens of any drug, device or cosmetic after paying or offering to pay therefor.
5.The Commissioner shall make, or cause to be made, examinations of samples and specimens secured under the provisions of this section to determine whether any of the provisions of this chapter is being violated.
Section 585.245 — Licensing of persons manufacturing, compounding, processing or packaging drugs, devices or cosmetics: Regulations; fees; inspection.,