6800 PHARMACIES AND PHARMACISTS

6800.8004 DRUG DISTRIBUTION AND CONTROL. Subpart 1. General. This part governs the mechanism by which a practitioner's prescription drug order is executed, from the time the drug is ordered and received in the pharmacy to the time the prescribed drug is dispensed to the patient. …

6800.8005 CYTOTOXIC AGENTS. Licensed pharmacies that prepare cytotoxic drugs must comply with the requirements in items A to F in addition to the requirements in parts 6800.8000 to 6800.8004. A. Cytotoxic drugs shall be compounded in a vertical flow, Class II, biological safety c…

6800.8006 DRUG USE REVIEW. Systematic processes of drug use review must be designed, followed, and documented to assure that appropriate patient outcomes occur from drug therapy on an ongoing basis. Statutory Authority: MS s 151.06 History: 18 SR 1145 Published Electronically: Se…

6800.8007 PATIENT CARE GUIDELINES. Subpart 1. Primary provider. The pharmacist who assumes the responsibilities under this part must ensure that there is a designated practitioner primarily responsible for the patient's medical care and that there is a clear understanding between…

6800.8008 QUALITY ASSURANCE. Subpart 1. Quality control program. There must be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product must be examined on a sampling basis as determined by the pharmacist-in-cha…

6800.8100 DEFINITIONS. Subpart 1. Manufacturers of radiopharmaceuticals. Any person, firm, or hospital compounding, mixing, deriving, repackaging, or otherwise preparing a radioactive drug shall be licensed as a manufacturer, unless the drug is prepared for use by: A. the medical…

6800.8200 SCOPE. Parts 6800.8100 to 6800.8700 are applicable to pharmacies and manufacturers dealing with radiopharmaceuticals; provided, however, that parts 6800.0100 to 6800.5600 shall also be applicable to such pharmacies, unless specifically exempted by parts 6800.8100 to 680…

6800.8300 MINIMUM STANDARDS. Proof of adequate space and equipment for storage, manipulation, manufacture, compounding, dispensing, safe handling, and disposal of radioactive material must be submitted to and approved by the board before a pharmacy license is issued by the board.…

6800.8400 PHARMACISTS HANDLING RADIOPHARMACEUTICALS. A pharmacist handling radiopharmaceuticals must be competent in the preparation, handling, storage, receiving, dispensing, disposition, and pharmacology of radiopharmaceuticals. The pharmacist must have completed a nuclear phar…

6800.8500 PHARMACIST-IN-CHARGE. A pharmacy handling radiopharmaceuticals shall not function without having a pharmacist who is competent in the preparation, handling, storage, receiving, dispensing, disposition, and pharmacology of radiopharmaceuticals in charge of the licensed p…

6800.8550 LABELING OF RADIOPHARMACEUTICALS. Subpart 1. Immediate container of bulk radiopharmaceutical product. Each compounded container must bear a label containing the following information: A. standard radiation symbol with words "Caution - Radioactive Material"; B. radiophar…

6800.8600 ACQUISITION, STORAGE, AND DISTRIBUTION. Only radiopharmaceuticals which are approved by the U.S. Food and Drug Administration or which are investigational drugs having IND or NDA status may be dispensed by a nuclear pharmacy. Radioactive materials shall be kept locked a…

6800.8700 RECORD KEEPING. A pharmacist handling radiopharmaceuticals shall maintain records of acquisition and disposition of radiopharmaceuticals for at least two years. In the case of investigational radiopharmaceuticals, the pharmacy records shall include an investigators prot…

6800.9100 DEFINITIONS. Subpart 1. Board. "Board" means the Minnesota Board of Pharmacy. Subp. 2. Hearing. "Hearing" includes a joint hearing of the board and any other administrative agency. Subp. 3. License. "License" means any license, permit, certificate of registration, or ot…

6800.9200 INITIATING PROCEEDINGS. Proceedings to revoke or suspend licenses may be initiated in one of two ways, except insofar as any order of suspension or revocation may be issued pursuant to a statute not requiring hearing: A. on a verified complaint by an individual or an ag…

6800.9300 PROCEDURE UPON FILING COMPLAINT. All complaints received pursuant to the provisions of part 6800.9200 shall be dealt with in accordance with the requirements of Minnesota Statutes, section 214.10. Statutory Authority: MS s 151.06 Published Electronically: September 21, …

6800.9400 STYLE OF PLEADINGS. All pleadings, notices, orders, and other papers filed in such proceedings shall be captioned "BEFORE THE MINNESOTA BOARD OF PHARMACY," and shall be entitled "IN THE MATTER OF THE SUSPENSION OR REVOCATION OF THE ____________ OF ______________ RESPOND…

6800.9500 FORM OF CHARGES. If the alleged offense is a continuing one, its general nature and the approximate time covered shall be stated in the complaint or notice of hearing. If a specific incident is relied on, it shall be alleged with such particularity as to time, place, an…

6800.9600 ORDER FOR AND NOTICE OF HEARING. Notices of hearing shall be addressed to the respondent at the last known post office address. All hearings shall be conducted pursuant to Minnesota Statutes, chapter 14, and the rules for contested cases of the Office of Administrative …

6800.9700 SERVICE AND FILING OF PAPERS. Unless otherwise provided by law, all orders, notices, and other papers may be served by the director of the board by first class, certified, or registered mail addressed to the party at the last known post office address, or to the attorne…

6800.9900 VARIANCES. Subpart 1. Right to request variance. The pharmacist-in-charge of a pharmacy requesting a variance, or in the case of manufacturers, wholesalers, or gas distributors, a person responsible for the operation, may request that the board grant a variance from any…

6800.9920 DISPENSING AND DISTRIBUTION OF LEGEND MEDICAL GASES. Parts 6800.9920 to 6800.9924 apply to the retail sale and distribution of legend medical gases. Statutory Authority: MS s 151.06; 151.19 History: 14 SR 617 Published Electronically: September 21, 2011

6800.9921 REGISTRATION. Subpart 1. Annual registration required. Every person or establishment selling or distributing legend medical gases in Minnesota at retail that is not currently licensed as a pharmacy, pharmacist, medical gas manufacturer, medical gas wholesaler, or practi…

6800.9922 RESTRICTED SALES. No person or establishment shall sell or distribute legend medical gases at retail to anyone other than: A. a patient on the basis of a prescription from a practitioner; or B. a hospital, a practitioner as defined in Minnesota Statutes, section 151.01,…

6800.9923 LABELING. No person or distributor may sell or distribute any legend medical gas product at retail without the manufacturer's intact federally required labeling. Statutory Authority: MS s 151.06; 151.19 History: 14 SR 617; 18 SR 1145 Published Electronically: September …

6800.9924 RECORDS. A sale or distribution of legend medical gases by registered distributors of these items at retail must be limited to the prescription or order of a licensed practitioner. The orders or prescriptions must be maintained for at least two years, must be filed by p…

6800.9950 DISPENSING BY PRACTITIONERS. Parts 6800.9951 to 6800.9954 apply to medical, dental, veterinary, and other licensed practitioners engaged in dispensing drugs and controlled substances. Statutory Authority: MS s 151.06 History: 18 SR 1145 Published Electronically: Septemb…

6800.9951 DRUG STORAGE. Practitioners engaged in dispensing drugs shall have a separate locked drug storage area for the safe storage of drugs. Access to the drug supply shall be limited to persons who have legal authority to dispense and to those under their direct supervision. …

6800.9952 DISPENSING. Subpart 1. Who may dispense. A dispensing practitioner shall personally perform all dispensing functions described in part 6800.3100 that are required of a pharmacist when the dispensing is being done in a pharmacy. A practitioner may delegate functions that…

6800.9953 LABELING. Prescription containers, other than those dispensed in unit dose under part 6800.3750, shall be labeled in accordance with part 6800.3400. Statutory Authority: MS s 151.06 History: 18 SR 1145 Published Electronically: September 21, 2011

6800.9954 RECORDS. A practitioner engaged in dispensing drugs shall keep on file at each location from which dispensing is taking place a record of drugs received, administered, dispensed, sold, or distributed. The records shall be readily retrievable, shall be maintained for at …