Application For Pharmacy Practice Site, Manufacturer, Outsourcing

FACILITY, OXYGEN SUPPLIER AND WHOLESALER/DISTRIBUTOR LICENSES. (1) Application for a license to operate as a pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor within the state of Tennessee shall be submitted to the office of the board at least thirty (30) days prior to the scheduled opening date. No pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor may open within the state of Tennessee until a license has been obtained; and such license will not be issued until an inspection by an authorized representative of the board has been made. (2) An application for an existing pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor physically located within the state of Tennessee must be filed when the pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor changes name, location or ownership. (a) Transactions constituting a change of ownership include, but are not limited to, the following: 1. A sole proprietor becomes a member of a partnership or corporation, which succeeds him as the new operator; 2. A partnership dissolves; INTRODUCTORY RULES CHAPTER 1140-01 3. One partnership is replaced by another through the removal, addition or substitution of a partner; 4. Two (2) or more corporations merge and the originally licensed corporation does not survive; and 5. Transfers between levels of government. (b) Transactions which do not constitute a change of ownership include, but are not limited to, the following: 1. Changes in the membership of a corporate board of directors or board of trustees; 2. Two (2) or more corporations merge and the originally licensed corporation survives; and 3. Corporate stock transfers or sales, even when a controlling interest. (3) No out-of-state pharmacy practice site, manufacturer outsourcing facility, oxygen supplier or wholesaler/distributor shall conduct business in the state of Tennessee until such pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor obtains the required license from the board. In order to obtain a license for a pharmacy practice site, manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor physically located out-of-state the following standards must be met. (a) Pharmacy practice site. 1. Submit an application for a license, which shall include the address of the pharmacy practice site, name of owner if a sole proprietorship, names of partners if a partnership or names and titles of all officers if a corporation and names of all pharmacists who practice at the site, together with the appropriate application fee. The director shall be notified in writing within thirty (30) days of any change in the information contained on the original application for a license, including names of pharmacists practicing at the site. 2. Comply with all statutorily authorized directions and requests for information from the board. 3. Maintain at all times a current permit, license or registration to conduct the pharmacy practice site in compliance with the laws of the state in which the site is physically located. 4. Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the pharmacy practice site is physically located. Thereafter, the pharmacy practice site shall submit to the director a copy of any subsequent inspection report conducted by the regulatory or licensing agency of the state in which the site is physically located. (i) An out-of-state pharmacy practice site engaged in compounding must provide an inspection performed within the previous twelve (12) months. (ii) An inspection completed by the United States Food and Drug Administration, or an inspection performed by the National Association of Boards of Pharmacy in lieu of an inspection by the regulatory or licensing INTRODUCTORY RULES CHAPTER 1140-01 agency of the state in which the pharmacy practice site is physically located is acceptable. 5. Maintain records of prescription orders dispensed to and/or of medication assessments provided to persons residing in Tennessee. 6. All records of prescription orders prepared and dispensed to persons residing in Tennessee shall be readily retrievable from other records. 7. During regular hours of operation, but not less than six (6) days per week nor for a minimum of forty (40) hours per week provide access to a pharmacist by a toll- free telephone service. A toll-free number shall be placed on the label affixed to the dispensing container for each prescription dispensed to a person residing in Tennessee. 8. Designate a pharmacist in charge who shall be responsible for compliance with the provisions in this section, and who shall hold a current Tennessee pharmacist license. 9. All out-of-state pharmacy practice sites shall comply with the requirements for patient counseling, patient profiling, drug regimen review and pharmaceutical care as set forth at 1140-03-.01. 10. The Board may require additional information before issuing or renewing a pharmacy license to ensure compliance with applicable laws of this state and rules of the Board. (b) Manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor. 1. Submit an application for a license, which shall include the address of the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor, name of owner if a sole proprietorship, names of partners if a partnership or names and titles of all officers if a corporation, together with the appropriate application fee. The director shall be notified in writing within thirty (30) days of any change in the information contained on the original application for a license. 2. Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor is physically located, or by the Food & Drug Administration. Thereafter, the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor shall submit to the director a copy of any subsequent inspection report conducted by the regulatory or licensing agency of the state in which the manufacturer, outsourcing facility, oxygen supplier or wholesaler/distributor is physically located, or by the FDA. 3. Comply with the requirements contained in Chapter 1140-09 of the rules of the Board of Pharmacy. (4) Representatives of a manufacturer, outsourcing facility or wholesaler/distributor conducting business in the state of Tennessee and who possesses and distributes controlled substances shall obtain a controlled substance registration from the Board of Pharmacy. (5) Any entity licensed as or applying for licensure as manufacturer or outsourcing facility conducting business in the state of Tennessee and who manufactures, prepares, propagates, repackages, or processes sterile drug products or biological products using aseptic INTRODUCTORY RULES CHAPTER 1140-01 processing must register and possess a modifier as a sterile manufacturer with the Board of Pharmacy in accordance with this chapter. This section shall not apply to wholesalers/distributors of sterile products. (6) It shall be unlawful for any person to procure or attempt to procure a license or certificate of registration for such person or for any other person by making any false representations. (7) In determining whether to grant a license under this rule, the board shall require from the applicant proof satisfactory to the board that the: (a) Applicant is of good moral character, or, if the applicant is a partnership or corporation, that the managing officers are of good moral character; and (b) That the applicant is equipped as to land, buildings and equipment necessary to conduct the business for which the application has been submitted. (8) Upon request, the Board may waive selected portions of these requirements so long as any waiver granted is consistent with the Board’s authority under Tenn. Code Ann. Title 63, Chapters 1 and 10, and Tenn. Code Ann. Title 4, Chapter 5.