Section 25.13. Personnel

(a) A person may not operate as a manufacturer of drugs unless the drugs are manufactured under the supervision of a registered pharmacist, chemist or other person possessing at least 5 years’ experience in the manufacture of drugs or another person approved by the secretary as qualified by scientific or technical training or experience to perform the duties of supervision as may be necessary to protect the public health and safety.

(b) A person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drugs shall be excluded from direct contact with drug products until the condition is corrected. Employes shall be instructed to report to supervisory personnel conditions that may have an adverse effect on drug products.