|(a) Current license. All establishments, except those exempt from licensing by law, shall be currently licensed by the department and shall be in substantial compliance with the Acts and the Rules as they apply to each specific type of operation. (b) Current compliant inspection. All establishments shall have a current compliant inspection as follows: (1) distributors or wholesalers of foods, drugs, or medical devices, within 24 months of application; (2) manufacturers of foods, drugs, or medical devices, within 12 months of application; (3) manufacturers, distributors, or wholesalers of cosmetic products, within 24 months of application; (4) producers, processors, and distributors of milk or dairy products, within 3 months of application; and (5) producers or distributors of molluscan shellfish, within 3 months of application. (c) Private Labelers. Private Labelers can only apply for and receive a certificate of free sale and sanitation in the name of the private labeler. Private labelers are responsible for purity and labeling of products and for compliance with all applicable laws and regulations. For purposes of this regulation, regardless of license type issued, a private labeler can only be issued a certificate of free sale and sanitation. (d) Product requirements. Products shall be manufactured in Texas, and/or warehoused, distributed, and sold from Texas. Products shall be available for inspection at the licensed location. (e) Rule or Act violations. A certificate of free sale and sanitation and/or certificate of origin and sanitation shall not be issued if substantive violations of the applicable Acts or Rules exist as determined by the department. Applicants whose application for a certificate is denied may appeal the decision pursuant to the provisions of §229.307 of this title (relating to Appeal Procedures).