2023 New York Laws › EDN - Education › Title 8 - The Professions › Article 137 - 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, wholesaler, manufacturer or outsourcing facility.
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. Outsourcing facility's registration.
a.   Obtaining  a  registration.  An  outsourcing  facility  shall  be
registered as follows:
(1) An application for initial registration or renewal of registration
shall be made on a form prescribed by the department.
(2) An application for initial registration shall be accompanied by  a
fee of eight hundred twenty-five dollars.
b.  Renewal of registration. All outsourcing facilities' registrations
shall be renewed  on  a  date  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 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-five 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.
e. Report. Upon initially registering as an outsourcing  facility  and
every  six  months thereafter, each outsourcing facility shall submit to
the executive secretary of the state board of pharmacy a report:
(1) identifying the drugs  compounded  by  such  outsourcing  facility
during the previous 6-month period; and
(2)  with  respect  to  each drug identified under subparagraph one of
this paragraph, providing the active  ingredient;  the  source  of  such
active  ingredient;  the National Drug Code number of the source drug or
bulk active  ingredient,  if  available;  the  strength  of  the  active
ingredient  per  unit;  the dosage form and route of administration; the
package description; the number of individual units  produced;  and  the
National Drug Code number of the final product, if assigned.
f.  Conduct  of  outsourcing  facility.  Every owner of an outsourcing
facility is responsible for the strength, quality, purity  and  labeling
thereof  of  all compounded drugs, subject to the guaranty provisions of
this article and the public health law. Every outsourcing facility shall
be under the  immediate  supervision  and  management  of  a  pharmacist
licensed to practice in New York state.
g.  Applicant  for  registration.  An applicant for registration of an
outsourcing facility 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 stakeholders having a ten
percent or greater interest in the corporation.
6. 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,
outsourcing  facility  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.
7. Penalties. A  pharmacy,  wholesaler,  manufacturer  or  outsourcing
facility registered under this section shall be under the supervision of
the  board  of  regents and shall be subject to disciplinary proceedings
and penalties in accordance with article  one  hundred  thirty  of  this
chapter  in  the  same  manner and to the same extent as individuals and
professional service corporations with respect  to  their  licenses  and
registrations,  provided that failure to comply with the requirements of
this section shall constitute professional misconduct.
8. 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.
9.  Supervision  requirements  for  wholesalers  transfilling  medical
oxygen.  Wholesalers  registered  under  this  section  which  transfill
medical  oxygen  shall ensure any person responsible for supervising the
transfilling of medical oxygen is:
a. a respiratory therapist certified by a national accrediting body;
b. a person holding a bachelor's degree  in  chemistry,  microbiology,
chemical engineering or a related field;
c.  a  person having two years of education beyond high school and two
years  experience  in  the  handling   of   compressed   medical   gases
satisfactory to the state board of pharmacy; or
d.  a  person  having  training  in  accordance  with the requirements
established in section 211.25  of  title  21  of  the  code  of  federal
regulations.