Legislation

Search OpenLegislation Statutes
This entry was published on 2014-09-22
The selection dates indicate all change milestones for the entire volume, not just the location being viewed. Specifying a milestone date will retrieve the most recent version of the location before that date.
SECTION 6808
Registering and operating establishments
Education (EDN) CHAPTER 16, TITLE 8, ARTICLE 137
§ 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.