§ 6808 — Registering and operating establishments

§ 6808. Registering and operating establishments. 1. No person, firm,\ncorporation or association shall possess drugs, prescriptions or poisons\nfor the purpose of compounding, dispensing, retailing, wholesaling, or\nmanufacturing, or shall offer drugs, prescriptions or poisons for sale\nat retail or wholesale unless registered by the department as a\npharmacy, wholesaler, manufacturer or outsourcing facility.\n 2. Pharmacies.\n a. Obtaining a registration. A pharmacy shall be registered as\nfollows:\n (1) The application shall be made on a form prescribed by the\ndepartment.\n (2) The application shall be accompanied by a fee of three hundred\nforty-five dollars.\n (3) To secure and retain a registration, a pharmacy must be equipped\nwith facilities, apparatus, utensils and stocks of drugs and medicines\nsufficient to permit the prompt and efficient compounding and dispensing\nof prescriptions, as prescribed by regulation.\n b. Renewal of registration. All pharmacy registrations shall be\nrenewed on dates set by the department. The triennial registration fee\nshall be two hundred sixty dollars or a pro rated portion thereof as\ndetermined by the department. At the time of renewal, the owner of every\npharmacy shall report under oath to the department any facts required by\nthe board of pharmacy.\n c. Display of registration. The registration shall be conspicuously\ndisplayed at all times in the pharmacy. The names of the owner or owners\nof a pharmacy shall be conspicuously displayed upon the exterior of such\nestablishment. The names so displayed shall be presumptive evidence of\nownership of such pharmacy by such person or persons. In the event that\nthe owner of a licensed pharmacy is not a licensed pharmacist, the\npharmacy registration issued shall also bear the name of the licensed\npharmacist having personal supervision of the pharmacy. In the event\nthat such licensed pharmacist shall no longer have personal supervision\nof the pharmacy, the owner shall notify the department of such fact and\nof the name of the licensed pharmacist replacing the pharmacist named on\nthe license and shall apply for an amended registration showing the\nchange. The amended registration must be attached to the original\nregistration and displayed in the same manner. Both the owner and the\nsupervising pharmacist shall be responsible for carrying out the\nprovisions of this article.\n d. Change of location. In the event that the location of a pharmacy\nshall be changed, the owner shall apply to the department for inspection\nof the new location and endorsement of the registration for the new\nlocation. The fee for inspection and endorsement shall be fifty dollars,\nunless it appears to the satisfaction of the department that the change\nin location is of temporary nature due to fire, flood or other disaster.\n e. Conduct of a pharmacy. Every owner of a pharmacy is responsible for\nthe strength, quality, purity and the labeling thereof of all drugs,\ntoxic substances, devices and cosmetics, dispensed or sold, subject to\nthe guaranty provisions of this article and the public health law. Every\nowner of a pharmacy or every pharmacist in charge of a pharmacy shall be\nresponsible for the proper conduct of this pharmacy. Every pharmacy\nshall be under the immediate supervision and management of a licensed\npharmacist at all hours when open. No pharmacist shall have personal\nsupervision of more than one pharmacy at the same time.\n f. A pharmacy as a department. When a pharmacy is operated as a\ndepartment of a larger commercial establishment, the area comprising the\npharmacy shall be physically separated from the rest of the\nestablishment, so that access to the pharmacy and drugs is not available\nwhen a pharmacist is not on duty. Identification of the area within the\npharmacy by use of the words "drugs", "medicines", "drug store", or\n"pharmacy" or similar terms shall be restricted to the area licensed by\nthe department as a pharmacy.\n g. Limited pharmacy registration. (1) When, in the opinion of the\ndepartment, a high standard of patient safety, consistent with good\npatient care, can be provided by the registering of a pharmacy within a\nhospital, nursing home or extended care facility which does not meet all\nof the requirements for registration as a pharmacy, the department may\nwaive any requirements pertaining to full-time operation by a licensed\npharmacist, minimum equipment, minimum space and waiting area, provided\nthat when the waiver of any of the above requirements is granted by the\nboard, the pharmaceutical services to be rendered by the pharmacy shall\nbe limited to furnishing drugs to patients registered for treatment by\nthe hospital, and to in-patients for treatment by the nursing home or\nextended care facility.\n (2) When in the opinion of the department, a high standard of patient\nsafety, consistent with good patient care, can be provided by the\nregistering of a pharmacy within a facility distributing dialysis\nsolutions for patients suffering from end stage renal disease and where\nthe pharmaceutical services to be rendered by the pharmacy shall be\nlimited to furnishing dialysis solutions to patients for whom such has\nbeen prescribed by a duly authorized prescriber, the department may\nwaive certain requirements, including, but not limited to, full-time\noperation by a licensed pharmacist, minimum equipment, and minimum space\nand waiting area. Such solutions shall only be dispensed by employees\nwho have completed an approved training program and who have\ndemonstrated proficiency to perform the task or tasks of assemblying,\nlabeling or delivering a patient order and who work under the general\nsupervision of a licensed pharmacist who shall be responsible for the\ndistribution, record keeping, labeling and delivery of all dialysis\nsolutions dispensed by the distributor as required by the department.\n (3) The department shall promulgate such rules or regulations\nconsistent with this paragraph as are necessary to ensure the safe\ndistribution of such dialysis solution, including establishment\nregistration and proper record keeping, storage, and labeling.\n (4) The initial registration fee and renewal fee for a limited\npharmacy shall be three hundred forty-five dollars for each triennial\nregistration period.\n h. Applicant registration. An applicant for registration as a pharmacy\nshall be of good moral character, as determined by the department. In\nthe case of a corporate applicant, the requirement shall extend to all\nofficers and directors and to stockholders having a ten percent or\ngreater interest in the corporation.\n 4. Wholesaler's or manufacturer's registration.\n a. Obtaining a registration. A wholesaler or manufacturer shall be\nregistered as follows:\n (1) The application shall be made on a form prescribed by the\ndepartment.\n (2) The application shall be accompanied by a fee of eight hundred\ntwenty-five dollars.\n b. Renewal of registration. All wholesalers' and manufacturers'\nregistrations shall be renewed on dates set by the department. The\ntriennial registration fee shall be five hundred twenty dollars or a pro\nrated portion thereof as determined by the department.\n c. Display of registration. The registration shall be displayed\nconspicuously at all times in the place of business.\n d. Change of location. In the event that the location of such place of\nbusiness shall be changed, the owner shall apply to the department for\ninspection of the new location and endorsement of the registration for\nthe new location. The fee for inspection and endorsement shall be one\nhundred seventy dollars, unless it appears to the satisfaction of the\ndepartment that the change in location is of a temporary nature due to\nfire, flood or other disaster.\n 5. Outsourcing facility's registration.\n a. Obtaining a registration. An outsourcing facility shall be\nregistered as follows:\n (1) An application for initial registration or renewal of registration\nshall be made on a form prescribed by the department.\n (2) An application for initial registration shall be accompanied by a\nfee of eight hundred twenty-five dollars.\n b. Renewal of registration. All outsourcing facilities' registrations\nshall be renewed on a date set by the department. The triennial\nregistration fee shall be five hundred twenty dollars or a pro rated\nportion thereof as determined by the department.\n c. Display of registration. The registration shall be displayed\nconspicuously in the place of business.\n d. Change of location. In the event that the location of such place of\nbusiness shall be changed, the owner shall apply to the department for\ninspection of the new location and endorsement of the registration for\nthe new location. The fee for inspection and endorsement shall be one\nhundred seventy-five dollars, unless it appears to the satisfaction of\nthe department that the change in location is of a temporary nature due\nto fire, flood or other disaster.\n e. Report. Upon initially registering as an outsourcing facility and\nevery six months thereafter, each outsourcing facility shall submit to\nthe executive secretary of the state board of pharmacy a report:\n (1) identifying the drugs compounded by such outsourcing facility\nduring the previous 6-month period; and\n (2) with respect to each drug identified under subparagraph one of\nthis paragraph, providing the active ingredient; the source of such\nactive ingredient; the National Drug Code number of the source drug or\nbulk active ingredient, if available; the strength of the active\ningredient per unit; the dosage form and route of administration; the\npackage description; the number of individual units produced; and the\nNational Drug Code number of the final product, if assigned.\n f. Conduct of outsourcing facility. Every owner of an outsourcing\nfacility is responsible for the strength, quality, purity and labeling\nthereof of all compounded drugs, subject to the guaranty provisions of\nthis article and the public health law. Every outsourcing facility shall\nbe under the immediate supervision and management of a pharmacist\nlicensed to practice in New York state.\n g. Applicant for registration. An applicant for registration of an\noutsourcing facility shall be of good moral character, as determined by\nthe department. In the case of a corporate applicant, the requirement\nshall extend to all officers and directors and stakeholders having a ten\npercent or greater interest in the corporation.\n 6. Inspection. The state board of pharmacy and the department of\neducation, and their employees designated by the commissioner, shall\nhave the right to enter any pharmacy, wholesaler, manufacturer,\noutsourcing facility or vehicle and to inspect, at reasonable times,\nsuch factory, warehouse, establishment or vehicle and all records\nrequired by this article, pertinent equipment, finished and unfinished\nmaterials, containers, and labels.\n 7. Penalties. A pharmacy, wholesaler, manufacturer or outsourcing\nfacility registered under this section shall be under the supervision of\nthe board of regents and shall be subject to disciplinary proceedings\nand penalties in accordance with article one hundred thirty of this\nchapter in the same manner and to the same extent as individuals and\nprofessional service corporations with respect to their licenses and\nregistrations, provided that failure to comply with the requirements of\nthis section shall constitute professional misconduct.\n 8. Sale of drugs at auction. No controlled substance or substances and\nno poisonous or deleterious drugs or drugs in bulk or in opened\ncontainers shall be sold at auction unless the place where such drugs\nare sold at auction shall have been registered by the board, and unless\nsuch sale shall be under the personal supervision of a licensed\npharmacist. Drugs in open containers shall not be sold at auction unless\nthe seller shall have in his possession a certificate of the board\nshowing that such drugs have been inspected and meet the requirements of\nthis article. In the event that the drug so sold is one as to which this\narticle or any federal statute or any regulation adopted pursuant to\nthis article or an applicable federal statute require that the\nexpiration date be stated on each package, such drug may not be sold at\nauction after such expiration date or when such expiration date will\noccur within a period of thirty days or less from the date of sale.\n 9. Supervision requirements for wholesalers transfilling medical\noxygen. Wholesalers registered under this section which transfill\nmedical oxygen shall ensure any person responsible for supervising the\ntransfilling of medical oxygen is:\n a. a respiratory therapist certified by a national accrediting body;\n b. a person holding a bachelor's degree in chemistry, microbiology,\nchemical engineering or a related field;\n c. a person having two years of education beyond high school and two\nyears experience in the handling of compressed medical gases\nsatisfactory to the state board of pharmacy; or\n d. a person having training in accordance with the requirements\nestablished in section 211.25 of title 21 of the code of federal\nregulations.\n