N.Y. Education Law § 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.