2010 New York Code
EDN - Education
Title 8 - THE PROFESSIONS
Article 137 - (6800 - 6828) PHARMACY
6808 - Registering and operating establishments.

§ 6808. Registering  and operating establishments. 1. No person, firm,
  corporation or association shall possess drugs, prescriptions or poisons
  for the purpose of compounding, dispensing, retailing,  wholesaling,  or
  manufacturing,  or  shall offer drugs, prescriptions or poisons for sale
  at retail  or  wholesale  unless  registered  by  the  department  as  a
  pharmacy, store, wholesaler, or manufacturer.
    2. Pharmacies.
    a.  Obtaining  a  registration.  A  pharmacy  shall  be  registered as
  follows:
    (1) The application  shall  be  made  on  a  form  prescribed  by  the
  department.
    (2)  The  application  shall  be accompanied by a fee of three hundred
  forty-five dollars.
    (3) To secure and retain a registration, a pharmacy must  be  equipped
  with  facilities,  apparatus, utensils and stocks of drugs and medicines
  sufficient to permit the prompt and efficient compounding and dispensing
  of prescriptions, as prescribed by regulation.
    b. Renewal  of  registration.  All  pharmacy  registrations  shall  be
  renewed  on  dates set by the department. The triennial registration fee
  shall be two hundred sixty dollars or a pro  rated  portion  thereof  as
  determined by the department. At the time of renewal, the owner of every
  pharmacy shall report under oath to the department any facts required by
  the board of pharmacy.
    c.  Display  of  registration. The registration shall be conspicuously
  displayed at all times in the pharmacy. The names of the owner or owners
  of a pharmacy shall be conspicuously displayed upon the exterior of such
  establishment. The names so displayed shall be presumptive  evidence  of
  ownership  of such pharmacy by such person or persons. In the event that
  the owner of a licensed pharmacy  is  not  a  licensed  pharmacist,  the
  pharmacy  registration  issued  shall also bear the name of the licensed
  pharmacist having personal supervision of the  pharmacy.  In  the  event
  that  such licensed pharmacist shall no longer have personal supervision
  of the pharmacy, the owner shall notify the department of such fact  and
  of the name of the licensed pharmacist replacing the pharmacist named on
  the  license  and  shall  apply  for an amended registration showing the
  change. The amended  registration  must  be  attached  to  the  original
  registration  and  displayed  in the same manner. Both the owner and the
  supervising  pharmacist  shall  be  responsible  for  carrying  out  the
  provisions of this article.
    d.  Change  of  location. In the event that the location of a pharmacy
  shall be changed, the owner shall apply to the department for inspection
  of the new location and endorsement of  the  registration  for  the  new
  location. The fee for inspection and endorsement shall be fifty dollars,
  unless  it appears to the satisfaction of the department that the change
  in location is of temporary nature due to fire, flood or other disaster.
    e. Conduct of a pharmacy. Every owner of a pharmacy is responsible for
  the strength, quality, purity and the labeling  thereof  of  all  drugs,
  toxic  substances,  devices and cosmetics, dispensed or sold, subject to
  the guaranty provisions of this article and the public health law. Every
  owner of a pharmacy or every pharmacist in charge of a pharmacy shall be
  responsible for the proper conduct  of  this  pharmacy.  Every  pharmacy
  shall  be  under  the immediate supervision and management of a licensed
  pharmacist at all hours when open. No  pharmacist  shall  have  personal
  supervision of more than one pharmacy at the same time.
    f.  A  pharmacy  as  a  department.  When  a pharmacy is operated as a
  department of a larger commercial establishment, the area comprising the
  pharmacy  shall  be  physically  separated  from   the   rest   of   the
  establishment, so that access to the pharmacy and drugs is not available

when  a pharmacist is not on duty. Identification of the area within the
  pharmacy by use of the words  "drugs",  "medicines",  "drug  store",  or
  "pharmacy"  or similar terms shall be restricted to the area licensed by
  the department as a pharmacy.
    g.  Limited  pharmacy  registration.   (1) When, in the opinion of the
  department, a high standard of  patient  safety,  consistent  with  good
  patient  care, can be provided by the registering of a pharmacy within a
  hospital, nursing home or extended care facility which does not meet all
  of the requirements for registration as a pharmacy, the  department  may
  waive  any  requirements pertaining to full-time operation by a licensed
  pharmacist, minimum equipment, minimum space and waiting area,  provided
  that  when the waiver of any of the above requirements is granted by the
  board, the pharmaceutical services to be rendered by the pharmacy  shall
  be  limited  to furnishing drugs to patients registered for treatment by
  the hospital, and to in-patients for treatment by the  nursing  home  or
  extended care facility.
    (2)  When in the opinion of the department, a high standard of patient
  safety, consistent with good  patient  care,  can  be  provided  by  the
  registering  of  a  pharmacy  within  a  facility  distributing dialysis
  solutions for patients suffering from end stage renal disease and  where
  the  pharmaceutical  services  to  be  rendered by the pharmacy shall be
  limited to furnishing dialysis solutions to patients for whom  such  has
  been  prescribed  by  a  duly  authorized prescriber, the department may
  waive certain requirements, including, but  not  limited  to,  full-time
  operation by a licensed pharmacist, minimum equipment, and minimum space
  and  waiting  area.  Such solutions shall only be dispensed by employees
  who  have  completed  an  approved  training  program   and   who   have
  demonstrated  proficiency  to  perform the task or tasks of assemblying,
  labeling or delivering a patient order and who work  under  the  general
  supervision  of  a  licensed pharmacist who shall be responsible for the
  distribution, record keeping, labeling  and  delivery  of  all  dialysis
  solutions dispensed by the distributor as required by the department.
    (3)   The  department  shall  promulgate  such  rules  or  regulations
  consistent with this paragraph as  are  necessary  to  ensure  the  safe
  distribution   of   such   dialysis  solution,  including  establishment
  registration and proper record keeping, storage, and labeling.
    (4) The initial  registration  fee  and  renewal  fee  for  a  limited
  pharmacy  shall  be  three hundred forty-five dollars for each triennial
  registration period.
    h. Applicant registration. An applicant for registration as a pharmacy
  shall be of good moral character, as determined by  the  department.  In
  the  case  of a corporate applicant, the requirement shall extend to all
  officers and directors and to  stockholders  having  a  ten  percent  or
  greater interest in the corporation.
    4. Wholesaler's or manufacturer's registration.
    a.  Obtaining  a  registration.  A wholesaler or manufacturer shall be
  registered as follows:
    (1) The application  shall  be  made  on  a  form  prescribed  by  the
  department.
    (2)  The  application  shall  be accompanied by a fee of eight hundred
  twenty-five dollars.
    b.  Renewal  of  registration.  All  wholesalers'  and  manufacturers'
  registrations  shall  be  renewed  on  dates  set by the department. The
  triennial registration fee shall be five hundred twenty dollars or a pro
  rated portion thereof as determined by the department.
    c. Display  of  registration.  The  registration  shall  be  displayed
  conspicuously at all times in the place of business.

d. Change of location. In the event that the location of such place of
  business  shall  be changed, the owner shall apply to the department for
  inspection of the new location and endorsement of the  registration  for
  the  new  location.  The fee for inspection and endorsement shall be one
  hundred  seventy  dollars,  unless it appears to the satisfaction of the
  department that the change in location is of a temporary nature  due  to
  fire, flood or other disaster.
    5.  Inspection.  The  state  board  of  pharmacy and the department of
  education, and their employees designated  by  the  commissioner,  shall
  have  the  right  to  enter  any  pharmacy, wholesaler, manufacturer, or
  registered store, or vehicle and to inspect, at reasonable  times,  such
  factory, warehouse, establishment or vehicle and all records required by
  this  article,  pertinent  equipment, finished and unfinished materials,
  containers, and labels.
    6.  Revocation  or  suspension.  A  pharmacy,  store,  wholesaler   or
  manufacturer  registration  may be revoked or suspended by the committee
  on professional conduct of the state board  of  pharmacy  in  accordance
  with the provisions of article one hundred thirty.
    7. Sale of drugs at auction. No controlled substance or substances and
  no  poisonous  or  deleterious  drugs  or  drugs  in  bulk  or in opened
  containers shall be sold at auction unless the place  where  such  drugs
  are  sold at auction shall have been registered by the board, and unless
  such sale  shall  be  under  the  personal  supervision  of  a  licensed
  pharmacist. Drugs in open containers shall not be sold at auction unless
  the  seller  shall  have  in  his  possession a certificate of the board
  showing that such drugs have been inspected and meet the requirements of
  this article. In the event that the drug so sold is one as to which this
  article or any federal statute or any  regulation  adopted  pursuant  to
  this   article  or  an  applicable  federal  statute  require  that  the
  expiration date be stated on each package, such drug may not be sold  at
  auction  after  such  expiration  date or when such expiration date will
  occur within a period of thirty days or less from the date of sale.