Pharmacy Permits

PURPOSE: This rule outlines the requirements for obtaining and maintaining a pharmacy permit. (1) All permits for the operation of a pharmacy shall expire on the date specified by the director of the Division of Professional Registration pursuant to 20 CSR 2231-2.010. (2) A pharmacy permit may be issued on the application of the owners. If the owner is a corporation, an officer of the corporation must sign the application as the applicant. If the owner is a partnership, a partner must sign the application as the applicant. If the owner is a limited liability partnership, a general partner must sign the application as the applicant. If the owner is a limited liability company, a member must sign the application as the applicant. In the case where a pharmacy is owned and operated by a person(s) who is a licensed pharmacist and in active charge of the pharmacy, the application for permit can be made by either party. Alternatively, a pharmacy permit application may be signed by an attorney or other person lawfully granted power of attorney to sign the application on the applicant’s behalf. In such case, a representative of the applicant shall review the application for truth and accuracy prior to submitting the application to the board. Proof of a power of attorney designation shall be submitted with the application. (A) An application for a pharmacy permit will become null and void if the applicant fails to complete the process for licensure within six (6) months of receipt of the application by the board. (3) When a pharmacy changes ownership, the original permit becomes void on the effective date of the change of ownership. Before any new business entity resulting from the change opens a pharmacy for business, it must obtain a new permit from the board. A temporary license shall be issued once a completed application and fee have been received by the board. The effective date of the temporary license may be the date the change of ownership is listed as effective on the application. Such license shall remain in effect until a permanent license is issued or denied by the board. (A) A change of ownership of a pharmacy owned by a sole proprietor is deemed to have occurred when— 1. The business is sold and the sale becomes final; 2. The proprietor enters into a partnership with another individual or business entity; or 3. The proprietor dies; provided, however, that the proprietor’s estate may continue to operate the pharmacy under the licensed pharmacist in good standing in this state, but in no case for a period of more than one (1) year and only so long as appropriate pharmacy permit fees are paid. (B) If a corporation owns a pharmacy, it is not necessary to obtain a new license if the owners of the stock change. If a limited liability partnership or a limited liability company owns a pharmacy, it is not necessary to obtain a new license if the partners or members of the company change, as long as the partnership or company is not dissolved by that change. It is necessary to file written notice with the State Board of Pharmacy within ten (10) days after a change occurs in partners in a limited liability partnership, or in members in a limited liability company. This notification must be in writing and certified. However, when a corporation, limited liability partnership, or limited liability company begins ownership of a pharmacy or transfers ownership of a pharmacy, a new license must be obtained regardless of the relationship between the previous and subsequent owners. (C) All individuals or business entities owning twenty-five percent (25%) or more of the ownership of any entity owning a pharmacy must notify the board within thirty (30) days of acquiring the percentage. (4) If an individual or business entity operating a pharmacy changes the location of the pharmacy to a new facility (structure), the pharmacy shall not open for business at the new location until the board or its duly authorized agent has inspected the premises of the new location and approved it and the pharmacy as being in compliance with section 338.240, RSMo and all other provisions of the law. Upon the approval and receipt of a change of location fee, the board shall issue a permit authorizing operation of a pharmacy at the new location, and the permit shall bear the same number as the previous pharmacy permit. However, the permit remains valid if the pharmacy address changes, but not the location, and an amended permit will be issued without charge under these circumstances. (A) Remodeling of a licensed pharmacy within an existing structure shall be deemed to have occurred when any change in the storage conditions of the Schedule II controlled substances is made or new connections to water/sewer resources are made or any changes in the overall physical security of drugs stored in the pharmacy as defined in 20 CSR 2220-2.010(1)(H) are made. Remodeling as defined within this section will not require the initiation of any change of location procedures. Satisfactory evidence of plans for any remodeling of a pharmacy must be provided to the board office thirty (30) days in advance of commencing such changes along with an affidavit showing any changes to the pharmacy physical plant and the projected completion date for any remodeling. (5) Permits, when issued, will bear an original number. Permits must be posted in a conspicuous place in the pharmacy to which it is issued. (6) No pharmacy permit will be issued unless the pharmacy area is under the direct supervision of a licensed pharmacist in good standing with the Missouri State Board of Pharmacy who is designated as the pharmacist-in-charge and meets the requirements of 20 CSR 2220-2.090. (7) If the owner/applicant is not the licensed pharmacistin-charge, then the pharmacist-in-charge must meet the requirements of 20 CSR 2220-2.090 and complete the pharmacistin-charge affidavit of the permit application. (8) The names of all pharmacists regularly working in a pharmacy shall be clearly displayed on the premises of every establishment having a pharmacy permit. (9) The following classes of pharmacy permits or licenses are hereby established for entities providing services as defined in section 338.010, RSMo: (A) Class A: Community/Ambulatory. A pharmacy that provides services as defined in section 338.010, RSMo to the general public; (B) Class B: Hospital Pharmacy. A pharmacy owned, managed, or operated by a hospital as defined by section 197.020, RSMo, or a clinic or facility under common control, management, or ownership of the same hospital or hospital system. This section shall not be construed to require a Class B hospital pharmacy permit or license for hospitals solely providing services within the practice of pharmacy under the jurisdiction of, and the licensure granted by, the Department of Health and Senior Services under and pursuant to Chapter 197, RSMo; (C) Class C: Long-Term Care. A pharmacy that provides services as defined in section 338.010, RSMo by the dispensing of drugs and devices to patients residing within long-term care facilities. A long-term care facility means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients; (D) Class D: Non-Sterile Compounding. A pharmacy that provides services as defined in section 338.010, RSMo and provides a non-sterile compounded product as defined in 20 CSR 2220-2.400(1) and meets the following criteria: 1. Any product made from any bulk active ingredient in a batch quantity as defined in 20 CSR 2220-2.400(3); (E) Class E: Radiopharmaceutical. A pharmacy that is not open to the general public and provides services as defined in section 338.010, RSMo that prepares and dispenses radioactive drugs as defined by the Food and Drug Administration (FDA) and drugs related to the use of radioactive drugs to health care providers for use in the treatment or diagnosis of disease and that maintains a qualified nuclear pharmacist as the pharmacist-in-charge; (F) Class F: Renal Dialysis. A pharmacy that is not open to the general public that provides services as defined in section 338.010, RSMo limited to the dispensing of renal dialysis solutions and other drugs and devices associated with dialysis care; (G) Class G: Medical Gas. A pharmacy that provides services as defined in section 338.010, RSMo through the provision of oxygen and other prescription gases for therapeutic uses; (H) Class H: Sterile Product Compounding. A pharmacy that provides services as defined in section 338.010, RSMo, and provides a sterile pharmaceutical as defined in 20 CSR 22202.200; (I) Class I: Consultant. A location where any activity defined in section 338.010, RSMo is conducted, but which does not include the procurement, storage, possession or ownership of any drugs from the location; (J) Class J: Shared Service. A pharmacy engaged in the processing of a request from another pharmacy to fill or refill a prescription drug order, or that performs or assists in the performance of functions associated with the dispensing process, drug utilization review (DUR), claims adjudication, refill authorizations, and therapeutic interventions; (K) Class K: Internet. A pharmacy that provides services as defined in section 338.010, RSMo, and is involved in the receipt, review, preparation, compounding, dispensing, or offering for sale any drugs, chemicals, medicines, or poisons for any new prescriptions originating from the Internet for greater than ninety percent (90%) of the total new prescription volume on any day; (L) Class L: Veterinary. A pharmacy engaged in the sale, dispensing, or filling of a legend drug for use in animals that must only be dispensed by prescription under state or federal law, provided that an additional Class L pharmacy permit shall not be required for pharmacies holding a Class A pharmacy permit that are also engaged in the sale, dispensing, or filling of a legend drug for animal use; (M) Class M: Specialty (bleeding disorder). A pharmacy that provides blood-clotting products and ancillary infusion equipment or supplies to patients with bleeding disorders, as defined by 20 CSR 2220-6.100; (N) Class N: Automated dispensing system (health care facility). An automated dispensing system as defined in 20 CSR 2220-2.900 that is located in a facility where medical services are provided to patients on the premises of or at the same physical location as such facility; (O) Class O: Automated dispensing system (ambulatory care). An automated dispensing system as defined in 20 CSR 22202.900 that is not located in a healthcare facility identified in subsection (9)(N) of this rule; and (P) Class P: Practitioner office/clinic. A pharmacy that is located in or on the premises of an office or clinic of a healthcare practitioner licensed in the United States who is authorized to prescribe medication by law and that provides pharmacy services as defined in section 338.010, RSMo, solely for patients of such practitioner or practitioners. (10) Pharmacy applications for initial licensure or renewals of a license shall accurately note each class of pharmacy that is practiced at the location noted on the application or renewal thereof. The permit (license) issued by the board shall list each class of licensure that the pharmacy is approved to engage in. A Pharmacy Change of Classification Application shall be filed with the board prior to adding or deleting any pharmacy classes with the applicable fee. (11) Prescriptions processed by any classification of licensed pharmacy must be provided by a practitioner licensed in the United States, authorized by law to prescribe drugs, and who has performed a medical evaluation of the patient as required by law. A pharmacist shall not dispense a prescription drug if the pharmacist has knowledge, or reasonably should know under the circumstances, that the prescription order for such drug was issued on the basis of an Internet-based questionnaire or without a valid pre-existing patient-practitioner relationship. AUTHORITY: section 338.140, RSMo Supp. 2013, and section 338.280, RSMo 2000.* This rule originally filed as 4 CSR 220-2.020. Original rule filed July 18, 1962, effective July 28, 1962. Amended: Filed Nov. 9, 1966, effective Nov. 19, 1966. Amended: Filed Oct. 27, 1970, effective Nov. 6, 1970. Amended: Filed Dec. 31, 1975, effective AND INSURANCE Jan. 10, 1976. Emergency amendment filed July 15, 1981, effective Sept. 28, 1981, expired Nov. 11, 1981. Amended: Filed Aug. 10, 1981, effective Nov. 12, 1981. Amended: Filed April 14, 1982, effective July 11, 1982. Amended: Filed March 14, 1983, effective June 11, 1983. Amended: Filed Feb. 11, 1985, effective May 11, 1985. Amended: Filed Dec. 16, 1985, effective May 11, 1986. Amended: Filed Aug. 1, 1986, effective Nov. 13, 1986. Amended: Filed Jan. 27, 1995, effective Sept. 30, 1995. Amended: Filed Jan. 6, 1998, effective Aug. 30, 1998. Amended: Filed June 29, 1999, effective Jan. 30, 2000. Amended: Filed March 15, 2000, effective Sept. 30, 2000. Amended: Filed Nov. 30, 2001, effective June 30, 2002. Amended: Filed Dec. 3, 2002, effective June 30, 2003. Amended: Filed May 13, 2005, effective Oct. 30, 2005. Moved to 20 CSR 2220-2.020, effective Aug. 28, 2006. Amended: Filed Aug. 21, 2006, effective April 30, 2007. Emergency amendment filed Jan. 19, 2016, effective Feb. 2, 2016, expired July 30, 2016. Amended: Filed Jan. 19, 2016, effective July 30, 2016. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011 and 338.280, RSMo 1951, amended 1971, 1981.