Source: http://op32.nysed.gov/prof/pharm/article137.htm
Timestamp: 2016-06-25 10:24:51
Document Index: 126567275

Matched Legal Cases: ['§6800', '§6801', '§6801', '§6802', '§6803', '§6804', '§6805', '§6806', '§6807', '§6808', '§6808', '§6808', '§6810', '§6811', '§6811', '§6811', '§6812', '§6813', '§6814', '§6815', '§6816', '§6816', '§6817', '§6818', '§6818', '§6819', '§6820', '§6821', '§6822', '§6823', '§6824', '§6825', '§6826', '§ 6826', '§6827', '§6828', '§6829', '§6830', '§6831', '§6800', '§6801', '§6801', '§6802', '§6803', '§6804', '§6805', '§6806', '§6807', '§6808', '§6808', '§6808', '§6810', '§6811', '§6811', '§6811', '§6812', '§6813', '§6814', '§6815', '§6816', '§6816', '§6817', '§6818', '§6818', '§6819', '§6820', '§6822', '§6823', '§6824', '§6825', '§6826', '§6826', '§6827', '§6828', '§6829', '§6830', '§6831']

/ Article 137 Education Law
§6800. Introduction | §6801.
Definition of practice of pharmacy | §6801-a. Collaborative drug therapy management demonstration program | §6802.
Definitions | §6803.
Practice of pharmacy and use of title "pharmacist" | §6804.
State board of pharmacy | §6805.
Requirements for a professional license | §6806.
Limited permits | §6807.
Exempt persons | §6808.
Registering and operating establishments | §6808-a.
Identification of pharmacists | §6808-b.
Registration of nonresident establishments | §6810.
Prescriptions | §6811.
Misdemeanors | §6811-a.
Certain drugs to be clearly marked or labeled | §6811-b.
Door-to-door distribution of drugs prohibited | §6812.
Special provisions | §6813.
Seizure | §6814.
Records of shipment | §6815.
Adulterating, misbranding and substituting | §6816.
Omitting to label drugs, or labeling them wrongly | §6816-a.
When substitution is required | §6817.
New drugs | §6818.
Adulterated and misbranded cosmetics | §6818-a.
Cosmetic samples | §6819.
Regulations making exceptions | §6820.
Certification of coal-tar colors for drugs and cosmetics | §6821.
Poison schedules; register | §6822.
Examinations and investigations | §6823.
Factory inspection | §6824.
Injunction proceedings | §6825.
Proof required in prosecution for certain violations | §6826.
Drug retail price lists | § 6826-a. Reducing certain copayments | §6827.
Mandatory continuing education | * §6828.
Certificates of administration	| §6829. Interpretation and translation requirements for prescription drugs and standardized medication labeling | §6830. Standardized patient-centered data elements | §6831. Special provisions relating to outsourcing facilities. §6800. Introduction.
This article applies to the profession of pharmacy. The general
* §6801. Definition of practice
The practice of the profession of pharmacy is defined as the
administering, preparing, compounding, preserving, or the dispensing
of drugs, medicines and therapeutic devices on the basis of prescriptions
or other legal authority, and collaborative drug therapy management in accordance with the provisions of section sixty-eight hundred one-a of this article.
A licensed pharmacist may execute a non-patient specific regimen
prescribed or ordered by a licensed physician or certified nurse
practitioner, pursuant to rules and regulations promulgated by
the commissioner. When a licensed pharmacist administers an immunizing
agent, he or she shall:
report such administration to the patient's attending primary
health care practitioner or practitioners, if any, pursuant
to rules and regulations of the commissioner;
provide information to the patient on the importance of
having a primary health care practitioner, developed by the
report such administration, absent of any individually
identifiable health information, to the department of health
in a manner required by the commissioner of health.
No pharmacist shall administer immunizing agents without receiving
training satisfactory to the commissioner and the commissioner
of health which shall include, but not be limited to, techniques
for screening individuals and obtaining informed consent; techniques
of administration; indications, precautions and contraindications
in the use of agent or agents; record keeping of immunization
and information; and handling emergencies, including anaphylaxis
and needlesticks.
The commissioner of health, in consultation with the commissioner,
shall prepare and submit a report to the governor and the legislature,
on or before December thirty-first, two thousand eleven, reporting
the results and evaluating the effectiveness and impact, if any,
of implementation of subdivision two of this section upon the
supply of such immunizing agents for the prevention of influenza
and pneumococcal disease, upon the geographical distribution
of such agents, and upon the distribution of such agents among
health care providers, including physicians, and pharmacies in
** When administering an immunization in a pharmacy, the licensed pharmacist shall provide an area for the immunization that provides for a patient's privacy.
** NB Repealed July 1, 2015
*NB Effective until March 31, 2016
§6801-a. Collaborative drug therapy management demonstration program.
"Collaborative drug therapy management" shall mean the performance of services by a pharmacist relating to the review, evaluation and management of drug therapy to a patient, who is being treated by a physician for a specific disease or disease state, in accordance with a written agreement or protocol with a voluntarily participating physician and in accordance with the policies, procedures, and protocols of the facility. Such agreement or protocol as entered into by the physician and a pharmacist, may include, and shall be limited to:
adjusting or managing a drug regimen of a patient, pursuant to a patient specific written order or protocol made by the patient's physician, which may include adjusting drug strength, frequency of administration or route of administration. Adjusting the drug regimen shall not include substituting or selecting a different drug which differs from that initially prescribed by the patient's physician unless such substitution is expressly authorized in the written order or protocol. The pharmacist shall be required to immediately enter into the patient record any change or changes made to the patient's drug therapy and shall use any reasonable means or method established by the facility or the department to notify any of the patient's other treating physicians with whom he or she does not have a written agreement or protocol regarding such changes. The patient's physician may prohibit, by written instruction, any adjustment or change in the patient's drug regimen by the pharmacist;
evaluating and, only if specifically authorized by the protocol and only to the extent necessary to discharge the responsibilities set forth in this section, ordering clinical laboratory tests related to the drug therapy management for the specific disease or disease state specified within the protocol; and
only if specifically authorized by the protocol and only to the extent necessary to discharge the responsibilities set forth in this section, ordering or performing routine patient monitoring functions as may be necessary in the drug therapy management, including the collecting and reviewing of patient histories, and ordering or checking patient vital signs, including pulse, temperature, blood pressure and respiration.
"Written agreement or protocol" shall mean a written document, pursuant to and consistent with any applicable state or federal requirements, that addresses a specific disease or disease state and that describes the nature and scope of collaborative drug therapy management to be undertaken by the pharmacist, in collaboration with the participating physician, in accordance with the provisions of this section.
"Physician" shall mean the physician, selected by or assigned to a patient, who has primary responsibility for the treatment and care of the patient for the disease or disease state that is the subject of the collaborative drug therapy management.
"Facility" shall mean a teaching hospital, including any diagnostic center, treatment center, or hospital-based outpatient department, however, for the purposes of this section, residential health care facilities and nursing homes shall be excluded. For the purposes of this section, a "teaching hospital" shall mean a hospital licensed pursuant to article twenty-eight of the public health law that is eligible to receive direct or indirect graduate medical education payments pursuant to article twenty-eight of the public health law.
A pharmacist who meets the experience requirements of paragraph b of this subdivision and who is employed by or otherwise affiliated with a facility shall be permitted to enter into a written agreement or protocol with a physician authorizing collaborative drug therapy management, subject to the limitations set forth in this section, within the scope of such employment or affiliation.
A participating pharmacist must:
have been awarded either a master of science in clinical pharmacy or a doctor of pharmacy degree;
maintain a current unrestricted license; and
have a minimum of two years experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation; or
have been awarded a bachelor of science in pharmacy;
within the last seven years, have a minimum of three years experience, of which at least one year of such experience shall include clinical experience in a health facility, which involves consultation with physicians with respect to drug therapy and may include a residency at a facility involving such consultation.
Notwithstanding any provision of this section, nothing herein shall authorize the pharmacist to diagnose disease. In the event that a treating physician may disagree with the exercise of professional judgment by the pharmacist, the judgment of the treating physician shall prevail.
The physician who is a party to a written agreement or protocol authorizing collaborative drug therapy management shall be employed by or otherwise affiliated with the same facility with which the pharmacist is also employed or affiliated.
The existence of a written agreement or protocol on collaborative drug therapy management and the patient's right to choose to not participate in collaborative drug therapy management shall be disclosed to any patient who is eligible to receive collaborative drug therapy management. Collaborative drug therapy management shall not be utilized unless the patient or the patient's authorized representative consents, in writing, to such management. If the patient or the patient’s authorized representative consents, it shall be noted on the patient's medical record. If the patient or the patient's authorized representative who consented to collaborative drug therapy management chooses to no longer participate in such management, at any time, it shall be noted on the patient's medical record. In addition, the existence of the written agreement or protocol and the patient's consent to such management shall be disclosed to the patient's primary physician and any other treating physician or healthcare provider.
Participation in a written agreement or protocol authorizing collaborative drug therapy management shall be voluntary, and no patient, physician, pharmacist, or facility shall be required to participate.
Nothing in this section shall be deemed to limit the scope of practice of pharmacy nor be deemed to limit the authority of pharmacists and physicians to engage in medication management prior to the effective date of this section and to the extent authorized by law.
* NB Repealed September 14, 2015
§6802. Definitions.
"Pharmacy" means any place, other than a registered
store, in which drugs, prescriptions or poisons are possessed
for the purpose of compounding, preserving, dispensing or retailing,
or in which drugs, prescriptions or poisons are compounded, preserved,
dispensed or retailed, or in which such drugs, prescriptions
or poisons are by advertising or otherwise offered for sale at
"Formulary" means the latest edition of the official
national formulary, and its supplement.
"Pharmacopeia", when not otherwise limited, means
the latest edition of the official United States pharmacopeia,
"Homeopathic pharmacopeia" means the official homeopathic
pharmacopeia of the United States, and its supplement.
"Official compendium" means the official United States
pharmacopeia, official homeopathic pharmacopeia of the United
States, official national formulary, or their supplements.
"Drugs" means:
Articles recognized in the official United States pharmacopeia,
official homeopathic pharmacopeia of the United States,
or official national formulary.
Articles intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man or animals.
Articles (other than food) intended to affect the structure
or any function of the body of man or animals.
Articles intended for use as a component of any article
specified in paragraphs a, b, or c; but does not include
"Cosmetics" means:
Articles intended to be rubbed, poured, sprinkled or
sprayed on, introduced into or otherwise applied to the
human body for cleansing, beautifying, promoting attractiveness,
or altering the appearance.
Articles intended for use as a component of any such articles;
except that the term shall not include soap.
"Poison", where not otherwise limited, means any
drug, chemical or preparation likely to be destructive to adult
human life in quantity of sixty grains or less.
"Label" means a display of written, printed or pictorial
matter upon the immediate container of any drug, device or cosmetic.
Any requirement made by or under authority of this article, that
any word, statement, or other information appear on the label
shall not be considered to be complied with unless such word,
statement or other information also appears on the outside container
or wrapper, if there be any, of the retail package of such drug,
device or cosmetic or is easily legible through the outside container
or wrapper.
"Labeling" means all labels and other written, printed
or pictorial matter:
Upon any drug, device or cosmetic or any of its containers
or wrappers, or
Accompanying such drug, device or cosmetic.
"Misbranding". If a drug, device or cosmetic is alleged
to be misbranded because the labeling is misleading, or if an
advertisement is alleged to be false because it is misleading
then in determining whether the labeling or advertisement is
misleading there shall be taken into account (among other things)
not only representations made or suggested by statement, word,
design, device, sound or any combination thereof, but also the
extent to which the labeling fails to reveal facts material in
the light of such representations or material with respect to
consequences which may result from the use of the drug, device,
or cosmetic to which the labeling or advertising relates under
the conditions of use prescribed in the labeling or advertising
thereof or under such conditions of use as are customary or usual.
No drug, device or cosmetic which is subject to, and complies
with regulations promulgated under the provisions of the federal
food, drug, and cosmetic act, relating to adulteration and misbranding
shall be deemed to be adulterated or misbranded in violation
of the provisions of this article because of its failure to comply
with the board's regulations, or the rules of the state board
of pharmacy, insofar as the regulations are in conflict with
regulations relating to adulteration and misbranding under the
"Antiseptic". The representation of a drug, device
or cosmetic in its labeling, as an antiseptic, shall be considered
to be a representation that it is a germicide, except in the
case of a drug purporting to be, or represented as, an antiseptic
for inhibitory use as a wet dressing, ointment, dusting powder,
or such other use as involves prolonged contact with the body.
"New drug" means:
Any drug not generally recognized, among experts qualified
and effectiveness of drugs, as safe and effective for use
under the conditions prescribed, recommended or suggested
by the drug's labeling, except that such a drug not so
recognized shall not be deemed to be a "new drug" if
at any time prior to September first, nineteen hundred
thirty-nine it was subject to the former federal food and
drug act of June thirtieth, nineteen hundred six, as amended,
and if at such time its labeling contained the same representations
concerning the conditions of its use;
Any drug, the composition of which is such that the drug,
as a result of investigations to determine its safety and
effectiveness for use under such conditions, has become recognized,
but which has not otherwise than in such investigations been
used to a material extent or for a material time under such
"Device" means instruments, apparatus, and contrivances,
including their components, parts and accessories, intended:
For use in the diagnosis, cure, mitigation, treatment,
or prevention of disease in man or animals; or
To affect the structure or any function of the body of
man or animals.
The term "Federal Food, Drug and Cosmetic Act" means
the Federal Food, Drug, and Cosmetic Act of the United States
of America, approved June twenty-fifth, nineteen hundred thirty-eight,
officially cited as public document number seven hundred seventeen-seventy-fifth
congress (chapter six hundred seventy-five--third session), and
all its amendments now or hereafter enacted.
"Wholesaler" means a person who bottles, packs or
purchases drugs, devices or cosmetics for the purpose of selling
or reselling to pharmacies or to other channels as provided in
"Advertisement" means all representations disseminated
in any manner or by any means, other than by labeling, for the
purpose of inducing, or which are likely to induce, directly
or indirectly, the purchase of drugs, devices or cosmetics.
"Controlled substance" means any drug defined as
a controlled substance by article thirty-three of the public
"Manufacturer" means a person who compounds, mixes,
prepares, produces, and bottles or packs drugs, cosmetics or
devices for the purpose of distributing or selling to pharmacies
or to other channels of distribution
* "Administer", for the purpose of section sixty-eight hundred one of this article, means the direct application of an immunizing agent to adults, whether by injection, ingestion or any other means, pursuant to a. a patient specific order or non-patient specific regimen prescribed or ordered by a physician or certified nurse practitioner, who has a practice site in the county in which the immunization is administered, for immunizations to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis or b. a patient specific order prescribed or ordered by a physician or certified nurse practitioner for immunizations to prevent acute herpes zoster or meningococcal disease or c. a patient specific order or non-patient specific regimen prescribed or ordered by a physician or certified nurse practitioner for immunizations to prevent meningococcal disease. If the county where the immunization is to be administered has a population of seventy-five thousand or less, then the licensed physician or certified nurse practitioner may be in an adjoining county. Such administration shall be limited to immunizing agents to prevent influenza or pneumococcal disease and medications required for emergency treatment of anaphylaxis.
* NB Effective October 29, 2013 until July 1, 2015
"Electronic prescription" means a prescription created, recorded,
or stored by electronic means; issued with an electronic signature; and
transmitted by electronic means, in accordance with regulations of the
commissioner and applicable regulations of the commissioner of health
and federal regulations; provided, however, that an original hard copy
prescription that is created electronically or otherwise may be transmitted from the prescriber to the pharmacist by facsimile and must be
manually signed. "Electronic" means of or relating to technology having
electrical, digital, magnetic, wireless, optical, electromagnetic, or
similar capabilities. "Electronic signature" means an electronic sound,
symbol, or process, attached to or logically associated with an electronic prescription and executed or adopted by a person with the intent
to sign the prescription, in accordance with regulations of the commissioner and applicable regulations of the commissioner of health and
federal regulations. "Compounding" means the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug with respect to an outsourcing facility under section 503B of the Federal Food, Drug and Cosmetic Act and further defined in this section.
"Outsourcing facility" means a facility that:
(a) is engaged in the compounding of sterile drugs;
(b) is currently registered as an outsourcing facility with the Secretary of Health and Human Services; and
(c) complies with all applicable requirements of federal and state law, including the Federal Food, Drug and Cosmetic Act.
"Sterile drug" means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under federal or state law.
§6803. Practice of pharmacy
and use of title "pharmacist".
shall practice pharmacy or use the title "pharmacist" or
any derivative.
§6804. State board of pharmacy.
A state board of pharmacy shall be appointed by the regents on
recommendation of the commissioner for the purpose of assisting
the regents and the department on matters of professional licensing
and professional conduct in accordance with section sixty-five
hundred eight of this title. The board shall be composed of not
less than nine pharmacists licensed in this state for at least
five years. An executive secretary to the board shall be appointed
by the regents on recommendation of the commissioner and shall
be a pharmacist licensed in this state for at least five years.
To regulate the practice of pharmacy and the employment of
interns and employees in pharmacies,
To regulate and control the sale, distribution, character and
standard of drugs, poisons, cosmetics, devices and new drugs,
To employ inspectors and chemists,
To prevent the sale or distribution of such drugs, poisons,
cosmetics, devices and new drugs as do not conform to the provisions
of this article or of the public health law,
To investigate alleged violations of the provisions of this
article, through its own investigative personnel or those of
other agencies, to conduct hearings, to levy money penalties,
and to bring alleged violations to the notice of the attorney
To issue limited permits or registrations.
§6805. Requirements for a professional
To qualify for a pharmacist's license, an applicant shall fulfill
or equivalent degree in pharmacy, in accordance with the
Experience: have experience satisfactory to the board and
and in accordance with the commissioner's regulations;
Citizenship or immigration status: be a United States citizen
or an alien lawfully admitted for permanent residence in
Fees: pay a fee of one hundred seventy-five dollars to
the department for admission to a department conducted examination
and for an initial license, a fee of eighty-five dollars
for each re-examination, a fee of one hundred fifteen dollars
for an initial license for persons not requiring admission
to a department conducted examination, and a fee of one hundred
fifty-five dollars for each triennial registration period.
On or before April first, nineteen hundred seventy-two, any
person who holds a valid license as "druggist" in this
state shall make application and on the payment of fees specified
in this title be licensed by the department as a pharmacist.
Such person shall have all of the rights, privileges, duties
and responsibilities of a pharmacist.
§6806. Limited permits.
The department may issue a limited permit for employment as
a "pharmacy intern" to:
A student enrolled in the last two years of a registered
program in pharmacy, or
A graduate of a program in pharmacy which meets standards
established by the commissioner's regulations who is engaged
in meeting the experience requirements or whose application
for initial licensure is pending with the department.
A pharmacy intern may, as determined by the commissioner's
regulations, practice as a pharmacist under the immediate personal
A limited permit issued to a pharmacy intern shall have an
expiration date of five years from the date of issue. Limited
permits may be renewed once for a period not to exceed two years.
Fees. The fee for each limited permit issued to a pharmacy
intern shall be seventy dollars.
§6807. Exempt persons.
Unlicensed assistants from being employed in licensed
pharmacies for purposes other than the practice of pharmacy;
Any physician, dentist, veterinarian or other licensed
health care provider legally authorized to prescribe drugs
under this title who is not the owner of a pharmacy, or registered
store, or who is not in the employ of such owner, from supplying
his patients with such drugs as the physician, dentist, veterinarian
or other licensed health care provider legally authorized
to prescribe drugs under this title deems proper in connection
with his practice, provided, however, that all such drugs
shall be dispensed in a container labeled with the name and
address of the dispenser and patient, directions for use,
and date of delivery, and in addition, such drug shall bear
a label containing the proprietary or brand name of the drug
and, if applicable, the strength of the contents, unless
the person issuing the prescription specifically states on
the prescription in his own handwriting, that the name of
the drug and the strength thereof should not appear on the
label; provided further that if such drugs are controlled
substances, they shall be dispensed pursuant to the requirements
of article thirty-three of the public health law;
Any merchant from selling proprietary medicines, except
those which are poisonous, deleterious or habit forming,
or materials and devices specifically exempted by regulations
of the department or by the public health law;
Any personnel in an institution of higher learning from
using prescription-required drugs on the premises for authorized
research, experiments or instruction, in accordance with
the department's regulations and, if such drugs are controlled
substances, in accordance with title III of article thirty-three
The necessary and ordinary activities of manufacturers
and wholesalers, subject to the provisions of article thirty-three
Notwithstanding the provisions of paragraph b of subdivision
one of this section, no prescriber who is not the owner of
a pharmacy, or registered store, or who is not in the employ
of such owner, may dispense more than a seventy-two hour
supply of drugs, except for:
persons practicing in hospitals as defined in section
twenty-eight hundred one of the public health law;
the dispensing of drugs at no charge to their patients;
persons whose practices are situated ten miles or more
from a registered pharmacy;
the dispensing of drugs in a clinic, infirmary or health
service that is operated by or affiliated with a post-secondary
persons licensed pursuant to article one hundred thirty-five
the dispensing of drugs in a medical emergency as defined
in subdivision six of section sixty-eight hundred ten
the dispensing of drugs that are diluted, reconstituted
or compounded by a prescriber;
the dispensing of allergenic extracts; or
the dispensing of drugs pursuant to an oncological
or AIDS protocol.
The commissioner, in consultation with the commissioner
of health, may promulgate regulations to implement this subdivision
and may, by regulation, establish additional renewable exemptions
for a period not to exceed one year from the provisions of
A pharmacist may dispense drugs and devices to a registered
professional nurse, and a registered professional nurse may possess
and administer, drugs and devices, pursuant to a non-patient
specific regimen prescribed or ordered by a licensed physician
or certified nurse practitioner, pursuant to regulations promulgated
by the commissioner and the public health law.
§6808. Registering and operating
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.
Obtaining a registration. A pharmacy shall be registered
The application shall be made on a form prescribed
The application shall be accompanied by a fee of
three hundred forty-five dollars.
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.
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
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.
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
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
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
Limited pharmacy registration.
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
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.
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.
The initial registration fee and renewal fee for a
limited pharmacy shall be three hundred forty-five dollars
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
Wholesaler's or manufacturer's registration.
Obtaining a registration. A wholesaler or manufacturer
shall be registered as follows:
eight hundred twenty-five dollars.
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
Display of registration. The registration shall be displayed
conspicuously at all times in the place of business.
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.
Outsourcing facility's registration.
Obtaining a registration. An outsourcing facility shall be
An application for initial registration or renewal of registration
shall be made on a form prescribed by the department. An application for initial registration shall be accompanied by a
fee of eight hundred twenty-five dollars.
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.
conspicuously in the place of business.
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
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:
identifying the drugs compounded by such outsourcing facility
during the previous 6-month period; and	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. 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
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. 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.
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.
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.
§6808-a. Identification of
Every pharmacist on duty shall be identified by a badge designed
by the state board of pharmacy, which shall contain his name and
§6808-b. Registration of nonresident
Definition. The term "nonresident establishment" shall mean any
pharmacy, manufacturer, wholesaler, or outsourcing facility located
outside of the state that ships, mails or delivers prescription drugs or
devices to other establishments, authorized prescribers and/or patients
residing in this state. Such establishments shall include, but not be
limited to, pharmacies that transact business through the use of the
Registration. All nonresident establishments that ship, mail,
or deliver prescription drugs and/or devices to other registered
establishments, authorized prescribers, and/or patients into
this state shall be registered with the department; except that
such registration shall not apply to intra-company transfers
between any division, affiliate, subsidiaries, parent or other
entities under complete common ownership and control. The provisions
of this subdivision shall apply solely to nonresident establishments
and shall not affect any other provision of this article.
Agent of record. Each nonresident establishment that ships,
mails or delivers drugs and/or devices into this state shall
designate a resident agent in this state for service of process
pursuant to rule three hundred eighteen of the civil practice
Conditions of registration. As a condition of registration,
a nonresident establishment shall comply with the following requirements:
Be licensed and/or registered and in good standing with
the state of residence;
Maintain, in readily retrievable form, records of drugs
and/or devices shipped into this state;
Supply, upon request, all information needed by the department
to carry out the department`s responsibilities under the
laws and rules and regulations pertaining to nonresident
Comply with all statutory and regulatory requirements of
the state where the nonresident establishment is located,
for prescription drugs or devices shipped, mailed or delivered
into this state, except that for controlled substances shipped,
mailed or delivered into this state, the nonresident pharmacy
shall follow federal law and New York law relating to controlled
The application shall be made in the manner and form prescribed
The application of establishments to be registered as a
manufacturer, wholesaler or outsourcing facility of drugs and/or devices
shall be accompanied by a fee as provided in section sixty-eight hundred
eight of this article; and
nonresident pharmacy shall be accompanied by a fee of three
hundred forty-five dollars and shall be renewed triennially
at a fee of two hundred sixty dollars.
Additional requirements. Nonresident pharmacies registered
Provide a toll-free telephone number that is available
during normal business hours and at least forty hours per
week, to enable communication between a patient in this
state and a pharmacist at the pharmacy who has access to
the patient`s records; and
Place such toll-free telephone number on a label affixed
to each drug or device container.
Disciplinary action. Except in emergencies that constitute
an immediate threat to public health, the department shall not
prosecute a complaint or otherwise take formal action against
a nonresident establishment based upon delivery of a drug into
this state or a violation of law, rule, or regulation of this
state if the agency having jurisdiction in the state where the
nonresident establishment is based commences action on the violation
complained of within one hundred twenty days from the date that
the violation was reported; provided however, that the department
may prosecute a complaint or take formal action against a nonresident
establishment if it determines that the agency having jurisdiction
in the state where the nonresident establishment is based has
unreasonably delayed or otherwise failed to take prompt and appropriate
action on a reported violation.
Revocation or suspension. A nonresident establishment that
fails to comply with the requirements of this section shall be
subject to revocation or suspension of its registration and other
applicable penalties in accordance with the provisions of article
one hundred thirty of this chapter.
Exception. The department may grant an exception from the registration
requirements of this section on the application of a nonresident
establishment that restricts its sale or dispensing of drugs
and/or devices to residents of this state to isolated transactions.
Rules and regulations. The department shall promulgate rules
and regulations to implement the provisions of this section.
§6810. Prescriptions.
No drug for which a prescription is required
by the provisions of the Federal Food, Drug and Cosmetic Act or by the
commissioner of health shall be distributed or dispensed to any person
except upon a prescription written by a person legally authorized to
issue such prescription. Such drug shall be compounded or dispensed by a
licensed pharmacist, and no such drug shall be dispensed without
affixing to the immediate container in which the drug is sold or
dispensed a label bearing the name and address of the owner of the
establishment in which it was dispensed, the date compounded, the number
of the prescription under which it is recorded in the pharmacist's
prescription files, the name of the prescriber, the name and address of
the patient, and the directions for the use of the drug by the patient
as given upon the prescription. All labels shall conform to such rules
and regulations as promulgated by the commissioner pursuant to section
sixty-eight hundred twenty-nine of this article. The prescribing and
dispensing of a drug which is a controlled substance shall be subject to
additional requirements provided in article thirty-three of the public
health law. The words "drug" and "prescription required drug" within the
meaning of this article shall not be construed to include soft or hard
contact lenses, eyeglasses, or any other device for the aid or
correction of vision. Nothing in this subdivision shall prevent a
pharmacy from furnishing a drug to another pharmacy which does not have
such drug in stock for the purpose of filling a prescription.
A prescription may not be refilled unless it bears a contrary
instruction and indicates on its face the number of times it may be
refilled. A prescription may not be refilled more times than allowed on
the prescription. The date of each refilling must be indicated on the
original prescription. Prescriptions for controlled substances shall be
refilled only pursuant to article thirty-three of the public health law.
A pharmacy registered with the department pursuant to section sixty-eight hundred eight of this article may not deliver a new or refilled prescription off premises without the consent of the patient or an individual authorized to consent on the patient's behalf. Consent shall include one of the following: the patient or authorized individual's signature of acceptance of each prescription delivered; the pharmacy may contact the patient or other authorized individual for consent to deliver and must document consent in the patient record; or for pharmacies that administer refill reminder or medication adherence programs and deliver off premises, if a signature is not received on each prescription, then the refill reminder program or medication adherence program shall be an OPT-IN program that is updated with patient consent every one hundred eighty days accompanied by a documented patient record review by a licensed pharmacist from the providing pharmacy and the patient before continuation of medication delivery can occur. Pharmacy providers who deliver medication without patient or authorized individual consent will be required to accept the return of the medication from the patient, provide that patient credit for any charges they may have paid, and will be required to destroy those medications sent without consent on delivery in accordance with applicable state and federal law. Nothing in this section shall be deemed to interfere with the requirements for refill reminder or medication adherence programs. Nothing in this section is intended to apply to long-term care pharmacy dispensing and delivery. A copy of a prescription for a controlled substance shall not be
furnished to the patient but may be furnished to any licensed
practitioner authorized to write such prescription. Copies of other
prescriptions shall be furnished to the patient at his request, but such
copies are issued for the informational purposes of the prescribers
only, and shall be so worded.
Oral prescriptions for controlled substances shall be filled
pursuant to article thirty-three of the public health law. A pharmacist
may fill an oral prescription for a drug, other than a controlled
substance, made by a practitioner legally authorized to prescribe drugs.
An oral authorization for the refill of a prescription, other than a
prescription for a controlled substance, may be made by a practitioner
legally authorized to prescribe drugs. The pharmacist receiving such
oral authorization for the refill of a prescription shall write on the
reverse side of the original prescription the date, time, and name of
the practitioner authorizing the refill of the prescription. An oral
prescription or an oral authorization for the refill of a prescription
for the drug, other than a controlled substance, may be communicated by
an employee of the prescribing practitioner; provided, however, the
contemporaneously reduce such prescription to writing;
dispense the substance in conformity with the labeling
requirements applicable to a written prescription; and
make a good faith effort to verify the employee's identity if
the employee is unknown to the pharmacist.
Oral prescriptions for patients in general hospitals, nursing
homes, residential health care facilities as defined in section
twenty-eight hundred one of the public health law, hospitals as defined
in subdivision ten of section 1.03 of the mental hygiene law, or
facilities operated by the office for people with developmental
disabilities, may be communicated to a pharmacist serving as a vendor of
pharmaceutical services based upon a contractual arrangement by an agent
designated by and under the direction of the prescriber or the
institution. Such agent shall be a health care practitioner currently
licensed and registered under this title.
Records of all prescriptions filled or refilled shall be maintained
for a period of at least five years and upon request made available for
inspection and copying by a representative of the department. Such
records shall indicate date of filling or refilling, doctor's name,
patient's name and address and the name or initials of the pharmacist
who prepared, compounded, or dispensed the prescription. Records of
prescriptions for controlled substances shall be maintained pursuant to
requirements of article thirty-three of the public health law.
Every prescription written in this state by a person authorized
to issue such prescription shall be on prescription forms containing one
line for the prescriber's signature. The prescriber's signature shall
validate the prescription. Every electronic prescription shall provide
for the prescriber's electronic signature, which shall validate the
electronic prescription. Imprinted conspicuously on every prescription
written in this state in eight point upper case type immediately below
the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED
GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless
the prescriber writes d a w in such box in the prescriber's own
handwriting or, in the case of electronic prescriptions, inserts an
electronic direction to dispense the drug as written, the prescriber's
signature or electronic signature shall designate approval of
No other letters or marks in such box shall prohibit substitution. No
prescription forms used or intended to be used by a person authorized to
issue a prescription shall have 'd a w' preprinted in such box. Such box
shall be placed directly under the signature line and shall be
three-quarters inch in length and one-half inch in height, or in
comparable form for an electronic prescription as may be specified by
regulation of the commissioner. Immediately below such box shall be
imprinted in six point type the words "Dispense As Written".
Notwithstanding any other provision of law, no state official, agency,
board or other entity shall promulgate any regulation or guideline
modifying those elements of the prescription form's contents specified
in this subdivision. To the extent otherwise permitted by law, a
prescriber may modify only those elements of the prescription form's
contents not specified in this subdivision. Notwithstanding any other
provision of this section or any other law, when a generic drug is not
available and the brand name drug originally prescribed is available and
the pharmacist agrees to dispense the brand name product for a price
that will not exceed the price that would have been charged for the
generic substitute had it been available, substitution of a generic drug
product will not be required. If the generic drug product is not
available and a medical emergency situation, which for purposes of this
section is defined as any condition requiring alleviation of severe pain
or which threatens to cause disability or take life if not promptly
treated, exists, then the pharmacist may dispense the brand name product
at his regular price. In such instances the pharmacist must record the
date, hour and nature of the medical emergency on the back of the
prescription and keep a copy of all such prescriptions.
The prescriber shall inform the patient whether he or she has
prescribed a brand name or its generic equivalent drug product.
The provisions of this subdivision shall not apply to a hospital
as defined in article twenty-eight of the public health law.
No prescriber shall be subjected to civil liability arising solely
from authorizing, in accordance with this subdivision, the substitution
by a pharmacist of a drug product pursuant to paragraph (o) of
subdivision one of section two hundred six of the public health law.
No prescription for a drug written in this state by a person
authorized to issue such prescription shall be on a prescription form
which authorizes the dispensing or compounding of any other drug. No
drug shall be dispensed by a pharmacist when such prescription form
includes any other drug.
With respect to drugs other than controlled substances, the
provisions of this subdivision shall not apply to pharmacists employed
by or providing services under contract to general hospitals, nursing
disabilities, who dispense drugs in the course of said employment or in
the course of providing such services under contract. With respect to
such pharmacists, each prescription shall be transcribed on a patient
specific prescription form.
Every prescription (whether or not for a controlled substance)
written in this state by a person authorized to issue such prescription
and containing the prescriber's signature shall, in addition to such
signature, be imprinted or stamped legibly and conspicuously with the
printed name of the prescriber who has signed the prescription. The
imprinted or stamped name of the signing prescriber shall appear in an
appropriate location on the prescription form and shall not be entered
in or upon any space or line reserved for the prescriber's signature.
The imprinted or stamped name shall not be employed as a substitute for,
or fulfill any legal requirement otherwise mandating that the
prescription be signed by the prescriber.
No person, corporation, association or other entity, not licensed
to issue a prescription pursuant to this title, shall wilfully cause
prescription forms, blanks or facsimiles thereof to be disseminated to
any person other than a person who is licensed to issue a prescription
pursuant to this title. A violation of this subdivision shall be a class
B misdemeanor punishable in accordance with the provisions of the penal
Notwithstanding any other provision of this section or any other
regulations establishing standards for electronic prescriptions are
promulgated by the commissioner of health, in consultation with the
commissioner pursuant to subdivision three of section two hundred
eighty-one of the public health law, no practitioner shall issue any
prescription in this state, unless such prescription is made by
electronic prescription from the practitioner to a pharmacy, except for
prescriptions: (a) issued by veterinarians; (b) issued or dispensed in
circumstances where electronic prescribing is not available due to
temporary technological or electrical failure, as set forth in
regulation; (c) issued by practitioners who have received a waiver or a
health, not to exceed one year, from the requirement to use electronic
prescribing, pursuant to a process established in regulation by the
commissioner of health, in consultation with the commissioner due to
economic hardship, technological limitations that are not reasonably
within the control of the practitioner, or other exceptional
circumstance demonstrated by the practitioner; (d) issued by a
practitioner under circumstances where, notwithstanding the
practitioner's present ability to make an electronic prescription as
required by this subdivision, such practitioner reasonably determines
that it would be impractical for the patient to obtain substances
prescribed by electronic prescription in a timely manner, and such delay
would adversely impact the patient's medical condition, provided that if
such prescription is for a controlled substance, the quantity that does
not exceed a five day supply if the controlled substance was used in
accordance with the directions for use; or (e) issued by a practitioner
to be dispensed by a pharmacy located outside the state, as set forth in
In the case of a prescription issued by a practitioner under
paragraph (b) of subdivision ten of this section, the practitioner shall
be required to file information about the issuance of such prescription
with the department of health as soon as practicable, as set forth in
paragraph (d) or (e) of subdivision ten of this section, the
practitioner shall, upon issuing such prescription, file information
about the issuance of such prescription with the department of health by
electronic means, as set forth in regulation.
The waiver process established in regulation pursuant to paragraph
prescribing under a waiver must notify the department in writing
promptly upon gaining the capability to use electronic prescribing, and
that a waiver shall terminate within a specified period of time after
Notwithstanding any other provision of law to the contrary, no
outsourcing facility may distribute or dispense any drug to any person
pursuant to a prescription unless it is also registered as a pharmacy in
this state and meets all other applicable requirements of federal and
§6811. Misdemeanors.
It shall be a class A misdemeanor for:
Any person knowingly or intentionally to prevent or refuse
to permit any board member or department representative to enter
a pharmacy or any other establishment for the purpose of lawful
Any person whose license has been revoked to refuse to deliver
Any pharmacist to display his license or permit it to be displayed
in a pharmacy of which he is not the owner or in which he is
not employed, or any owner to fail to display in his pharmacy
the license of the pharmacist employed in said pharmacy;
Any holder of a license to fail to display the license;
Any owner of a pharmacy to display or permit to be displayed
in his pharmacy the license of any pharmacist not employed in
said pharmacy;
Any person to carry on, conduct or transact business under
a name which contains as a part thereof the words "drugs", "medicines", "drugstore", "apothecary",
or "pharmacy", or similar terms or combination of terms,
or in any manner by advertisement, circular, poster, sign or
otherwise describe or refer to the place of business conducted
by such person, or describe the type of service or class of products
sold by such person, by the terms "drugs", "medicine", "drug
store", "apothecary", or "pharmacy",
unless the place of business so conducted is a pharmacy licensed
Any person to enter into an agreement with a physician, dentist,
podiatrist or veterinarian for the compounding or dispensing
of secret formula (coded) prescriptions;
Any person to sell or distribute any instrument or article,
or any recipe, drug or medicine for the prevention of conception
to a minor under the age of sixteen years; the sale or distribution
of such to a person other than a minor under the age of sixteen
years is authorized only by a licensed pharmacist but the advertisement
or display of said articles, within or without the premises of
such pharmacy is hereby prohibited; [Injunction - Injunctive relief against enforcement of subd. 8 of this section
which prohibited distribution of contraceptives to persons under
the age of 16, which prohibited distribution of contraceptives
to any other persons by persons other than pharmacists, and which
prohibited any display or advertisement of contraceptives was appropriate.
Population Services Intern. V. Wilson, D.C.N.Y. 1975, 398 F. Supp.
321, 97 S.Ct. 2010, 431 U.S. 678, 52 L.Ed.2d 675.]
Any person to manufacture, sell, deliver for sale, hold for
sale or offer for sale of any drug, device or cosmetic that is
adulterated or misbranded;
Any person to adulterate or misbrand any drug, device or cosmetic;
Any person to receive in commerce any drug, device or cosmetic
that is adulterated or misbranded, and to deliver or proffer
delivery thereof for pay or otherwise;
Any person to sell, deliver for sale, hold for sale, or offer
for sale any drug, device or cosmetic in violation of this article;
Any person to disseminate any false advertisement;
Any person to refuse to permit entry or inspection as authorized
Any person to forge, counterfeit, simulate, or falsely represent,
or without proper authority using any mark, stamp, tag, label
or other identification device authorized or required by rules
and regulations promulgated under the provisions of this article;
Any person to use for his own advantage, or reveal, other than
to the commissioner or his duly authorized representative, or
to the courts when relevant in any judicial proceedings under
this article, any information acquired under authority of this
article or concerning any method or process, which is a trade
Any person to alter, mutilate, destroy, obliterate or remove
the whole or any part of the labeling of, or the doing of any
other act with respect to a drug, device, or cosmetic, if such
act is done while such article is held for sale and results in
such article being misbranded;
Any person to use on the labeling of any drug or in any advertising
relating to such drug any representation or suggestion that an
application with respect to such drug is effective under section
sixty-eight hundred seventeen of this chapter or that such is
in compliance with the provisions of such section;
Any person to violate any of the provisions of section sixty-eight
hundred ten of this article;
hundred sixteen of this article;
Any person, to sell at retail or give away in tablet form bichloride
of mercury, mercuric chloride or corrosive sublimate, unless
such bichloride of mercury, mercuric chloride or corrosive sublimate,
when so sold, or given away, shall conform to the provisions
of national formulary XII. Nothing contained in this paragraph
shall be construed to prohibit the sale and dispensing of bichloride
of mercury in any form, shape, or color, when combined or compounded
with one or more other drugs or excipients, for the purposes
of internal medication only, or when sold in bulk in powder form,
or to any preparation containing one-tenth of a grain or less
of bichloride of mercury;
Any pharmacy to fail to properly post the list required by
section sixty-eight hundred twenty-six of this article;
Any pharmacy to change its current selling price without changing
the listed price as provided by section sixty-eight hundred twenty-six
Any person to refuse to permit access to or copying of any
record as required by this article; or
Any manufacturer to sell or offer for sale any drug not manufactured,
prepared or compounded under the personal supervision of a chemist
or licensed pharmacist or not labeled with the full name of the
Any outsourcing facility to sell or offer to sell any drug that
is not both compounded under the personal supervision of a licensed
pharmacist and labeled with the full name of the outsourcing facility.
§6811-a. Certain drugs to
be clearly marked or labeled.
Except as otherwise authorized in the Federal Food, Drug and
Cosmetic Act, no drug for which a prescription is required by the
provisions of the Federal Food, Drug and Cosmetic Act or by the
commissioner of health may be manufactured or commercially distributed
within this state in tablet or capsule form unless it has clearly marked
or imprinted on each such tablet or capsule in conformance with the
applicable plan required by subdivision three of this section:
an individual symbol, number, company name, words, letters,
marking or National Drug Code (hereinafter referred to as N. D. C.)
number identifying the manufacturer or distributor of the drug; and
an N. D. C. number, symbol, number, letters, words or marking
identifying such drug or combination of drugs.
Cosmetic Act, no drug for which any prescription is required by the
commissioner of health contained within a bottle, vial, carton or other
container, or in any way affixed or appended to or enclosed within a
package of any kind, and designed or intended for delivery in such
container or package to an ultimate consumer, shall be manufactured or
distributed within this state unless such container or package has
clearly and permanently marked or imprinted upon it in conformance with
the applicable plan required by subdivision three of this section:
an individual symbol, N. D. C. number, company name, number,
letters, words or marking identifying the manufacturer or distributor of
identifying such drug or combination of drugs; and
whenever the distributor of the prescription drug product does not
also manufacture the product the names and places of business of both
shall appear on the label in words clearly distinguishing each.
Each manufacturer and distributor shall prepare and submit
to the commissioner of health a proposed plan of the manufacturer
or distributor, as the case may be, to have its products
comply with the marking and labeling requirements of this
Such plan shall be in writing and shall give the respective
dates by which the various products manufactured or distributed
will each contain the required mark or label. The plan shall
state the reasons why the projected date of compliance has
been proposed and such other information deemed relevant
or that the commissioner of health shall require.
The commissioner may either approve the plan as proposed
or, after consultation with the manufacturer or distributor,
require an amendment or the commissioner may promulgate a
plan for the manufacturer or distributor. No plan or amendment
to the plan shall be effective until approved or promulgated
by the commissioner of health upon a finding by him that
the time limitations provided for therein are reasonable
and will best carry out the intendment of this section.
Each manufacturer and/or distributor shall publish and make
available, upon request, to the department of education, to each
physician, dentist, pharmacy, hospital or other institution wherein
such drugs may be used, a printed material which will identify
each imprint used by the manufacturer or distributor. Updated
materials shall be provided as changes occur, upon the filing
of an annual request. The provisions of this subdivision shall
be deemed to be complied with when a prescription drug product
is included in the Physician's Desk Reference.
Every person, firm or corporation violating the provisions
of this section for any prescription drug product shall be guilty
of an offense punishable by a fine of not less than twenty-five
hundred dollars nor more than ten thousand dollars. Any prescription
drug product prepared or manufactured in violation of this section
shall be contraband and subject to seizure either by the state
board of pharmacy or by any law enforcement officer of the state.
The provisions of this section shall not apply to any tablet
or capsule which contains a controlled substance as that term
is defined by article thirty-three of the public health law or
which is prepared or manufactured by a pharmacist duly licensed
by the state which is made by him for the purpose of retail sale
from his principal place of business and not intended for resale.
The commissioner of health may exempt a particular tablet or
capsule from the requirements of this section, upon application
by a manufacturer, on the grounds that labeling such a tablet
or capsule is unfeasible because of size or texture or other
As used in this section, the term "distributor" means
the person, firm, corporation or other entity which is not
the actual manufacturer of a prescription drug product but
which distributes such product for resale under the label
of such person, firm, corporation or entity.
For purposes of subdivision four "drug product" means
the entire supply of the finished dosage form of the drug.
§6811-b. Door-to-door distribution
of drugs prohibited.
It shall be a violation, punishable by a fine not to exceed two
hundred fifty dollars, for a manufacturer, distributor, or seller
of drugs or an employee or agent thereof to distribute a free sample
of any drug, other than a cosmetic not intended for ingestion,
to any residential dwelling unless the sample is given directly
to a person who is, or reasonably appears to be, over the age of
eighteen. This section shall not be construed to permit distribution
where otherwise prohibited by this chapter or any other law.
§6812. Special provisions.
Where any pharmacy, manufacturer, wholesaler or outsourcing
facility registered by the department is damaged by fire the board shall
be notified within a period of forty-eight hours, and the board shall
have power to impound all drugs for analysis and condemnation, if found
unfit for use. Where a pharmacy is discontinued, the owner of its
prescription records shall notify the department as to the disposition
of said prescription records, and in no case shall records be sold or
given away to a person who does not currently possess a registration to
operate a pharmacy.
Nothing in this article shall be construed as requiring the
prosecution or the institution of injunction proceedings for
minor violations of this article whenever the public interest
will be adequately served by a suitable written notice of warning.
The executive secretary of the state board of pharmacy is authorized
to conduct examinations and investigations for the purposes of
this article through officers and employees of the United States,
or through any health, food, or drug officer or employee of any
city, county or other political subdivision of this state.
§6813. Seizure.
Any drug, device or cosmetic that is adulterated, misbranded
or may not be sold under the provisions of this chapter, may
be seized on petition or complaint of the board and condemned
in the supreme court of any county in which it is found. Seizure
by process pursuant to the petition or complaint, or
if the secretary or other officer designated by him has
probable cause to believe that the article
is one which may not be sold under the provisions
of section sixty-eight hundred seventeen of this
chapter, or
is adulterated, or
is so misbranded as to be dangerous to health. The
article shall be seized by order of such officer. The
order shall describe the article to be seized, the place
where the article is located, and the officer or employee
making the seizure. The officer, in lieu of taking actual
possession, may affix a tag or other appropriate marking
to the article giving notice that the article has been
quarantined and warning all persons not to remove or
dispose of it by sale or otherwise until permission for
removal or disposal is given by the officer or the court.
In case of seizures or quarantine, pursuant to such order,
the jurisdiction of such court shall attach upon such
seizure or quarantine, and a petition or complaint for
condemnation shall be filed promptly.
The procedure for cases under this section shall conform as
much as possible to the procedure for attachment. Any issue of
fact joined in any case under this section shall be tried by
jury on the demand of either party. The court at any time after
seizure and up to the time of trial shall allow by order any
party or his agent or attorney to obtain a representative sample
of the condemned material, a true copy of the analysis on which
the proceeding was based, and the identifying marks or numbers,
if any, on the packages from which the samples analyzed were
Any drug, device or cosmetic condemned under this section shall
be disposed of by destruction or sale as the court may direct
after the decree in accordance with the provisions of this section.
The proceeds of the sale, if any, shall be paid into the state
treasury after deduction for legal costs and charges. However,
the drug, device or cosmetic shall not be sold contrary to the
provisions of this article. After entry of the decree, if the
owner of the condemned articles pays the costs of the proceeding
and posts a sufficient bond as security that the articles will
not be disposed of contrary to the provisions of this article,
the court may by order direct that the seized articles be delivered
to the owner to be destroyed or brought into conformance with
this article under supervision of the secretary. The expenses
of the supervision shall be borne by the person obtaining the
release under bond. Any drug condemned by reason of its being
a new drug which may not be sold under this article shall be
disposed of by destruction.
When the decree of condemnation is entered, court costs and
fees, storage and other expense shall be awarded against the
person, if any, intervening as claimant of the condemned articles.
In any proceeding against the board, or the secretary, or an
agent of either, because of seizure, or quarantine, under this
section, the board, or the secretary, or such agent shall not
be liable if the court finds that there was probable cause for
the acts done by them.
§6814. Records of shipment.
For the purpose of enforcing provisions of this article, carriers
engaged in commerce, and persons receiving drugs, devices or cosmetics
in commerce or holding such articles so received, shall, upon the
request of an officer duly assigned by the secretary, permit such
officer, at reasonable times, to have access to and to copy all
records showing the movement in commerce of any drug, device or
cosmetic, or the holding thereof during or after such movement,
and the quantity, shipper, and consignee thereof: and it shall
be unlawful for any such carrier or person to fail to permit such
access to and copying of any such record so requested when such
request is accompanied by a statement in writing specifying the
nature or kind of drug, device or cosmetic to which such request
relates: Provided, that evidence obtained under this section shall
not be used in a criminal prosecution of the person from whom obtained:
Provided further, that carriers shall not be subject to the other
provisions of this article by reason of their receipt, carriage,
holding or delivery of drugs, devices or cosmetics in the usual
course of business as carriers.
§6815. Adulterating, misbranding
and substituting.
Adultered drugs. A drug or device shall be deemed to be adulterated:
If it consists in whole or in part of any filthy,
putrid, or decomposed substance; or
if it has been prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious
if it is a drug and its container is composed, in
whole or in part, of any poisonous or deleterious substance
which may render the contents injurious to health;
if it is a drug and it bears or contains, for purposes
of coloring only, a coal-tar color other than one from
a batch that has been certified in accordance with
regulations provided in this article.
If it purports to be, or is represented as, a drug the
name of which is recognized in an official compendium, and
its strength differs from, or its quality or purity falls
below, the standard set forth in such compendium. Such determination
as to strength, quality or purity shall be made in accordance
with the tests or methods of assay set forth in such compendium,
or, in the absence or inadequacy of such tests or methods
of assay, then in accordance with tests or methods of assay
prescribed by regulations of the board of pharmacy as promulgated
under this article. Deviations from the official assays may
be made in the quantities of samples and reagents employed,
provided they are in proportion to the quantities stated
in the official compendium. No drug defined in an official
compendium shall be deemed to be adulterated under this paragraph
because (1) it exceeds the standard of strength therefor
set forth in such compendium, if such difference is plainly
stated on its label; or (2) it falls below the standard of
strength, quality, or purity therefor set forth in such compendium
if such difference is plainly stated on its label, except
that this clause shall apply only to such drugs, or classes
of drugs, as are specified in regulations which the board
shall promulgate when, as applied to any drug, or class of
drugs, the prohibition of such difference is not necessary
for the protection of the public health. Whenever a drug
is recognized in both the United States pharmacopoeia and
the homeopathic pharmacopoeia of the United States, it shall
be subject to the requirements of the United States pharmacopoeia
unless it is labeled and offered for sale as a homeopathic
drug, in which case it shall be subject to the provisions
of the homeopathic pharmacopoeia of the United States and
not to those of the United States pharmacopoeia.
If it is not subject to the provisions of paragraph b of
this subdivision and its strength differs from, or its purity
or quality falls below, that which it purports or is represented
If it is a drug and any substance has been
mixed or packed therewith so as to reduce its quality
or strength or
If it is sold under or by a name not recognized in or according
to a formula not given in the United States pharmacopoeia
or the national formulary but that is found in some other
standard work on pharmacology recognized by the board, and
it differs in strength, quality or purity from the strength,
quality or purity required, or the formula prescribed in,
the standard work.
Misbranded and substituted drugs and devices. A drug or device
shall be deemed to be misbranded:
If in package form, unless it bears a label containing
(1) the name and place of business of the manufacturer, packer,
or distributor; and (2) an accurate statement of the quantity
of the contents in terms of weight, measure, or numerical
count: Provided, that under clause (2) of this paragraph
the board may establish reasonable variations as to quantity
and exemptions as to small packages.
If any word, statement, or other information required by
or under authority of this article to appear on the label
or labeling is not prominently placed thereon with such conspicuousness
(as compared with other words, statements, designs, or devices,
in the labeling) and in such terms as to render it likely
to be read and understood by the ordinary individual under
If it is for use by man and contains any quantity of the
narcotic or hypnotic substance alpha eucaine, barbituric
acid, beta eucaine, bromal, cannabis, carbromal, chloral,
coca, cocaine, codeine, heroin, marihuana, morphine, opium,
paraldehyde, peyote, or sulphonmethane; or any chemical derivative
of such substance, which derivative has been by the secretary,
after investigation, found to be, and by regulations under
this article, or by regulations promulgated by the board,
designated as, habit forming; unless its label bears the
name and quantity, or proportion, of such substance or derivative
and in juxtaposition therewith the statement "Warning--May
If it is a drug and is not designated solely by a name
recognized in an official compendium unless its label bears
(1) the common or usual name of the drug, if such there be;
and (2) in case it is fabricated from two or more ingredients,
the common or usual name of each active ingredient, including
the kind and quantity by percentage or amount of any alcohol,
and also including, whether active or not, the name and quantity
or proportion of any bromides, ether, chloroform, acetanilid,
acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,
ouabain, strophanthin, strychnine, thyroid, or any derivative
or preparation of any such substances, contained therein:
Provided, that, to the extent that compliance with the requirements
of clause (2) of this paragraph is impracticable, exemptions
shall be established by regulations promulgated by the board.
Unless its labeling bears (1) adequate directions for use;
and (2) such adequate warnings against use in those pathological
conditions orby children where its use may be dangerous to
health, or against unsafe dosage or methods or duration of
administration or application, in such manner and form, as
are necessary for the protection of users: Provided, that,
applied to any drug or device, is not necessary for the protection
of the public health, the board shall promulgate regulations
exempting such drug or device from such requirement.
If it purports to be a drug the name of which is recognized
in an official compendium, unless it is packaged and labeled
as prescribed therein: Provided, that, the method of packing
may be modified with the consent of the secretary in accordance
with regulations promulgated by the board. Whenever a drug
with respect to packaging and labeling unless it is labeled
and offered for sale as a homeopathic drug, in which case
it shall be subject to the provisions of the homeopathic
pharmacopoeia of the United States, and not to those of the
If it is a drug and its container is so made, formed
or filled as to be misleading;
If it is an imitation of another drug; (3) if it
is offered for sale under the name of another drug;
If it bears a copy, counterfeit, or colorable imitation
of the trademark, label, container or identifying name
or design of another drug.
If it is dangerous to health when used in the dosage, or
with the frequency or duration prescribed, recommended or
Except as required by article thirty-three of the public
health law, the labeling provisions of this article shall
not apply to the compounding and dispensing of drugs on the
written prescription of a physician, a dentist, a podiatrist
or a veterinarian, which prescription when filled shall be
kept on file for at least five years by the pharmacist or
druggist. Such drug shall bear a label containing the name
and place of business of the dispenser, the serial number
and date of the prescription, directions for use as may be
stated in the prescription, name and address of the patient
and the name of the physician or other practitioner authorized
by law to issue the prescription. In addition, such label
shall contain the proprietary or brand name of the drug and,
if applicable, the strength of the contents, unless the person
issuing the prescription explicitly states on the prescription,
in his own handwriting, that the name of the drug and the
strength thereof should not appear on the label.
§6816. Omitting to label drugs,
or labeling them wrongly.
Any person, who, in putting up any drug, medicine, or food
or preparation used in medical practice, or making up any
prescription, or filling any order for drugs, medicines,
food or preparation puts any untrue label, stamp or other
designation of contents upon any box, bottle or other package
containing a drug, medicine, food or preparation used in
medical practice, or substitutes or dispenses a different
article for or in lieu of any article prescribed, ordered,
or demanded, except where required pursuant to section sixty-eight
hundred sixteen-a of this article, or puts up a greater or
lesser quantity of any ingredient specified in any such prescription,
order or demand than that prescribed, ordered or demanded,
except where required pursuant to paragraph (g) of subdivision
two of section three hundred sixty-five-a of the social services
law, or otherwise deviates from the terms of the prescription,
order or demand by substituting one drug for another, except
where required pursuant to section sixty-eight hundred sixteen-a
of this article, is guilty of a misdemeanor; provided, however,
that except in the case of physicians' prescriptions, nothing
herein contained shall be deemed or construed to prevent
or impair or in any manner affect the right of an apothecary,
druggist, pharmacist or other person to recommend the purchase
of an article other than that ordered, required or demanded,
but of a similar nature, or to sell such other article in
place or in lieu of an article ordered, required or demanded,
with the knowledge and consent of the purchaser. Upon a second
conviction for a violation of this section the offender must
be sentenced to the payment of a fine not to exceed one thousand
dollars and may be sentenced to imprisonment for a term not
to exceed one year. The third conviction of a violation of
any of the provisions of this section, in addition to rendering
the offender liable to the penalty prescribed by law for
a second conviction, shall forfeit any right which he may
possess under the law of this state at the time of such conviction,
to engage as proprietor, agent, employee or otherwise, in
the business of an apothecary, pharmacist, or druggist, or
to compound, prepare or dispense prescriptions or orders
for drugs, medicines or foods or preparations used in medical
practice; and the offender shall be by reason of such conviction
disqualified from engaging in any such business as proprietor,
agent, employee or otherwise or compounding, preparing or
dispensing medical prescriptions or orders for drugs, medicines,
or foods or preparations used in medical practice.
The provisions of this section shall not apply to the practice
of a practitioner who is not the proprietor of a store for
the dispensing or retailing of drugs, medicines and poisons,
or who is not in the employ of such a proprietor, and shall
not prevent practitioners from supplying their patients with
such articles as they may deem proper, and except as to the
labeling of poisons shall not apply to the sale of medicines
or poisons at wholesale when not for the use or consumption
by the purchaser; provided, however, that the sale of medicines
or poisons at whole-sale shall continue to be subject to
such regulations as from time to time may be lawfully made
by the board of pharmacy or by any competent board of health.
The provisions of this section shall not apply to a limited
pharmacy which prepares a formulary containing the brand
names and the generic names of drugs and of manufacturers
which it stocks, provided that it furnishes a copy of such
formulary to each physician on its staff and the physician
signs a statement authorizing the hospital to supply the
drug under any generic or non-proprietary name listed therein
and in conformity with the regulations of the commissioner
For the purposes set forth in this section, the terms prescription,
order or demand shall apply only to those items subject to provisions
of subdivision one of section sixty-eight hundred ten of this
chapter. The written order of a physician for items not subject
to provisions of subdivision one of section sixty-eight hundred
ten of this chapter shall be construed to be a direction, a fiscal
order or a voucher.
§6816-a. When substitution
A pharmacist shall substitute a less expensive drug product
containing the same active ingredients, dosage form and strength
as the drug product prescribed, ordered or demanded, provided
The prescription is written on a form which meets the
requirements of subdivision six of section sixty-eight
hundred ten of this article and the prescriber does not
prohibit substitution, or in the case of oral prescriptions,
the prescriber must expressly state whether substitution
is to be permitted or prohibited. Any oral prescription
that does not include such an express statement shall not
be filled; and
The substituted drug product is contained in the list of
drug products established pursuant to paragraph (o) of subdivision
one of section two hundred six of the public health law;
The pharmacist shall indicate on the label affixed to the
immediate container in which the drug is sold or dispensed
the name and strength of the drug product and its manufacturer
unless the prescriber specifically states otherwise. The
pharmacist shall record on the prescription form the brand
name or the name of the manufacturer of the drug product
In the event a patient chooses to have a prescription filled
by an out of state dispenser, the laws of that state shall prevail.
§6817. New drugs.
Except as otherwise provided in the Federal Food, Drug and
Cosmetic Act, no person shall sell, deliver, offer for sale, hold for
sale, or give away any new drug, unless:
an application with respect thereto has become effective, or in the
case of an investigational drug the sponsor has complied with the
applicable requirements, under the Federal Food, Drug, and Cosmetic Act,
when not subject to such act, such drug has been tested and has not
been found to be unsafe or ineffective for use under the conditions
prescribed, recommended or suggested in the labeling thereof, and, prior
to selling or offering for sale such drug, there has been filed with the
department an application setting forth
full reports of investigations which have been made to show
whether or not such drug is safe and effective for use;
a full list of the ingredients used as components of such drug;
a full statement of the composition of such drug;
a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing and packing of such
such samples of such drug and of the ingredients used as
components thereof as the board or secretary may require; and
specimens of the labeling proposed to be used for such drug.
An application provided for in paragraph b of subdivision one
shall become effective on the one hundred eightieth day after
the filing thereof, except that if the secretary or board finds,
after due notice to applicant and giving him an opportunity for
a hearing, that the drug is not safe and effective for use under
the conditions prescribed, recommended, or suggested in the proposed
labeling thereof, he shall, prior to the effective date of the
application, issue an order refusing to permit the application
A drug dispensed on a written or oral prescription of a physician,
dentist, podiatrist or veterinarian (except a controlled substance),
shall be exempt from the requirements of this section if such
drug bears a label containing the name and place of business
of the dispenser, the serial number and date of the prescription,
directions for use as may be stated in the prescription and the
name of the physician, dentist, podiatrist or veterinarian issuing
the prescription and the name of the patient. In addition, such
drug shall bear a label containing the proprietary or brand name
of the drug and, if applicable, the strength of the contents,
unless the person issuing the prescription explicitly states
on the prescription, in his own handwriting, that the name of
the drug and the strength thereof should not appear on the label.
The board shall promulgate regulations for exempting from the
operation of this section drugs (and with the concurrence of
the commissioner of health, pursuant to article thirty-three
of the public health law, controlled substances) intended solely
for investigational use by experts qualified by scientific training
and experience to investigate the safety and efficacy of drugs
and labeled "For Investigational Use Only". Such regulations
may, within the discretion of the board, among other conditions
relating to the protection of the public health, provide for
conditioning such exemptions upon:
The submission to the secretary before any clinical testing
of a new drug is undertaken of reports by the manufacturer
or sponsor of the investigation of such drug, of preclinical
tests, including tests on animals of such drug adequate
to justify the proposed clincial testing.
The manufacturer or the sponsor of the investigation of
a new drug proposed to be distributed to investigators for
clinical testing obtaining a signed agreement from each of
such investigators that patients to whom the drug is administered
will be under his personal supervision, or under the supervision
of investigators responsible to him, and that he will not
supply such drug to any other investigator or to clinics
for administration to human beings; and
The establishment and maintenance of such records and the
making of such reports to the board by the manufacturer or
the sponsor of the investigation of such drugs of data including,
but not limited to, analytical reports by investigators obtained
as the result of such investigational use of such drug as
the board finds will enable it to evaluate the safety and
effectiveness of such drug in the event of the filing of
an application pursuant to subdivision one of this section.
This section shall not apply to any drug which was licensed
under the federal virus, serum, and toxin act of July first,
nineteen hundred two (32 Stat. 728) or is licensed under section
two hundred sixty-two of the public health service act of July
first, nineteen hundred forty-four (58 Stat. 682), or under the
federal virus, serums, toxins, antitoxins and analogous products
act of March fourth, nineteen hundred thirteen (37 Stat. 832).
§6818. Adulterated and misbranded
A cosmetic shall be deemed to be adulterated:
If it bears or contains any poisonous or deleterious
substance which may render it injurious to users under
the conditions of use prescribed in the labeling thereof,
or under such conditions of use as are customary or usual:
Provided, that this provision shall not apply to coal-tar
hair dye, the label of which bears the following legend
conspicuously displayed thereon "Caution--this product
contains ingredients which may cause skin irritation on
certain individuals and a preliminary test according to
accompanying directions should first be made. This product
must not be used for dying the eyelashes or eyebrows; to
do so may cause blindness", and the labeling of which
bears adequate directions for such preliminary testing.
For the purpose of this paragraph and paragraph e the term "hair
dye" shall not include eyelash dyes or eyebrow dyes.
If it consists in whole or in part of any filthy, putrid,
or decomposed substance.
If it has been prepared, packaged, packed, shipped or held
in any insanitary condition or in any other condition whereby
it may have been rendered injurious to health.
If its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
If it is not a hair dye and it bears or contains a coal-tar
color other than one from a batch that has been certified
in accordance with regulations as provided by this article.
A cosmetic shall be deemed to be misbranded:
reasonable variations shall be permitted, and exemptions
as to small packages shall be established by regulations.
(as compared with other words, statements, designs, or devices
If its container is so made, formed, or filled as
to be misleading; or
of a trademark, label, or identifying name or design
of another cosmetic.
§6818-a. Cosmetic samples.
No person engaged in the business of selling cosmetics shall
provide for the use by or application to customers of any cosmetics,
except for use or application to the hand or arm as a sample
if such immediate container of cosmetics is to be used by or
applied to more than one customer. For the purposes of this section,
the term "cosmetic" shall not include perfume or cologne;
or samples removed from the immediate container with a single
use disposable applicator furnished to each customer; or samples
dispensed from a tube, pump, spray or shaker container; or samples
or applicators that have been cleansed before each use or application.
The provisions of this section shall be deemed to have been satisfied
if written instructions on the use or application of cosmetic
samples pursuant to this section are clearly and visibly posted
at or near the place of display of cosmetic samples. Nothing
contained in this section shall prohibit the use or application
of cosmetic samples by persons trained to apply cosmetics to
customers in accordance with the provisions of this section.
Notwithstanding any other provision of this article, a violation
of this section shall result in a civil penalty of one hundred
dollars for the first offense and a civil penalty of two hundred
fifty dollars for a second or subsequent offense.
§6819. Regulations making exceptions.
The board shall promulgate regulations exempting from any labeling
requirement of this article drugs, devices and cosmetics which
are, in accordance with the practice of the trade, to be processed,
labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on condition
that such drugs, devices and cosmetics are not adulterated or misbranded
under the provisions of this article upon removal from such processing,
labeling, or repacking establishment.
§6820. Certification of coal-tar
colors for drugs and cosmetics.
The board shall promulgate regulations providing for the listing
of coal-tar colors which are harmless and suitable for use in drugs
for purposes of coloring only and for use in cosmetics and for
the certification of batches of such colors, with or without harmless
The following schedules shall remain in force until revised
by the board and approved by the department.
Schedule A. Arsenic, atropine, corrosive sublimate, potassium
cyanide, chloral hydrate, hydrocyanic acid, strychnine and
all other poisonous vegetable alkaloids and their salts and
oil of bitter almond containing hydrocyanic acid.
Schedule B. Aconite, belladonna, cantharides, colchicum, conium
cotton root, digitalis, ergot, hellebore, henbane, phytolacca,
strophanthus, oil of savin, oil of tansy, veratrum viride and
their pharmaceutical preparations, arsenical solutions, carbolic
acid, chloroform, creosote, croton oil, white precipitate,
methyl or wood alcohol, mineral acids, oxalic acid, paris green,
salts of lead, salts of zinc, or any drug, chemical or preparation
which is liable to be destructive to adult human life in quantities
of sixty grains or less.
It shall be unlawful for any person to sell at retail or to
furnish any of the poisons of schedules A and B without affixing
or causing to be affixed to the bottle, box, vessel or package,
a label with the name of the article and the word "poison" distinctly
shown and with the name and place of business of the seller all
printed in red ink together with the name of such poisons printed
or written thereupon in plain, legible characters.
Manufacturers and wholesale dealers in drugs, medicines, pharmaceutical
preparations, chemicals or poisons shall affix or cause to be
affixed to every bottle, box, parcel or outer inclosure of any
original package containing any of the articles of schedule A
a suitable label or brand in red ink with the word "poison" upon
Every person who disposes of or sells at retail or furnishes
any poisons included in schedule A shall before delivering the
same enter in a book kept for that purpose the date of sale,
the name and address of the purchaser, the name and the quantity
of the poison, the purpose for which it is purchased and the
name of the dispenser. The poison register must be always open
for inspection by the proper authorities and must be preserved
for at least five years after the last entry. Such person shall
not deliver any of the poisons of schedule A or schedule B until
he has satisfied himself that the purchaser is aware of its poisonous
character and that the poison is to be used for a legitimate
purpose. The provisions of this paragraph do not apply to the
dispensing of drugs or poisons on a doctor's prescription.
The board may add to or may delete from any of the schedules
from time to time as such action becomes necessary for the protection
§6822. Examinations and investigations.
The secretary is authorized to conduct examinations and investigations
for the purposes of this article through officers and employees
of the United States, or through any health, food, or drug officer
or employee of any city, county or other political subdivision
of this state, duly commissioned by the secretary as an officer
§6823. Factory inspection.
For purposes of enforcement of this article, officers duly designated
by the secretary are authorized:
to enter, at reasonable times, any factory, warehouse or establishment
in which drugs, devices or cosmetics are manufactured, processed,
packed, or held, for introduction into commerce or are held after
such introduction, or to enter any vehicle being used to transport
or hold such drugs, devices or cosmetics in commerce; and
to inspect, at reasonable times, such factory, warehouse, establishment
or vehicle and all pertinent equipment, finished and unfinished
materials, containers, and labeling therein.
§6824. Injunction proceedings.
In addition to the remedies hereinafter provided, the secretary
is hereby authorized to apply to the court of the proper venue
for an injunction to restrain any person from (a) introducing or
causing to be introduced into commerce any adulterated or misbranded
drug, device or cosmetic; or (b) from introducing or causing to
be introduced in commerce any new drug which does not comply with
the provisions of this article; or (c) from disseminating or causing
to be disseminated a false advertisment, without being compelled
to allege or prove that an adequate remedy at law does not exist.
§6825. Proof required in prosecution
for certain violations.
In an action or proceeding, civil or criminal, against a person
for violating such provisions of this article which relate to
the possession of, compounding, retailing or dispensing of misbranded,
substituted or imitated drugs, poisons or cosmetics, when it
shall be necessary that an analysis be made for the purpose of
establishing the quality of such drug, poison or cosmetic so
as to determine the fact of misbranding, substituting or imitating,
then it shall be required to prove at the trial or hearing of
such action or proceeding, that the person, taking the same for
analysis separated it into two representative parts, hermetically
or otherwise effectively and completely sealed, delivered one
such sealed part to the seller, manufacturer, wholesaler, pharmacist,
druggist or storekeeper from whose premises such sample was taken
and delivered the other part so sealed to the chemist designated
by the state board of pharmacy; and the facts herein required
to be proven shall be alleged in the complaint or information
by which such action or proceeding was begun. The rules of the
board shall be proven prima facie by the certificate of the secretary.
Any person accused of violation of any of the provisions of
this article relating to adulterating, misbranding, substitution
or imitation shall not be prosecuted or convicted or suffer any
of the penalties, fines or forfeitures for such violation, if
he establishes upon the hearing or trial that the drug, device
or cosmetic alleged to be adulterated, misbranded, substituted
or imitated was purchased by him under a written guaranty of
the manufacturer or seller to the effect that said drug, device
or cosmetic was not adulterated or misbranded, within the meaning
of this article and proves that he has not adulterated, misbranded,
substituted or imitated the same, provided the seller has taken
due precaution to maintain the standard set for the drug, device
or cosmetic. A guaranty, in order to be a defense to a prosecution
or to prevent conviction or to afford protection, must state
that the drug, device or cosmetic to which it refers is not adulterated,
misbranded, substituted or imitated within the meaning of the
provisions of this article and must state also the full name
and place of business of the manufacturer, wholesaler, jobber
or other person from whom the drug, device or cosmetic was purchased,
and the date of purchase. The act, omission or failure of any
officer, agent or other employee acting for or employed by any
person within the scope of his authority or employment shall
in every case be the act, omission or failure of such person
as well as that of the officer, agent or other employee, and
such person shall be equally liable for violations of this article
by a partnership, association or corporation, and every member
of the partnership or association and the directors and general
officers of the corporation and the general manager of the partnership,
association or corporation shall be individually liable and any
action, prosecution or proceeding authorized by this article
may be brought against any or all of such persons. When any prosecution
under this article is made on the complaint of the board, any
fines collected shall be paid into the state treasury as provided
No publisher, radio-broadcast licensee, advertising agency,
or agency or medium for the dissemination of advertising, except
the manufacturer, packer, distributor, or seller of the commodity
to which the false advertisement relates, shall be subject to
the penalties provided by this article by reason of the dissemination
by him of any false advertisement, unless he has refused, on
the request of the secretary, to furnish the secretary the name
and post-office address of the manufacturer, packer, distributor,
seller or advertising agency, who caused him to disseminate such
§6826. Drug retail price lists.
Every pharmacy shall compile a drug retail price list, which
shall contain the names of the drugs on the list provided by
the board and the pharmacy`s corresponding retail prices for
each drug. Every pharmacy shall update its drug retail list at
least weekly. Every pharmacy shall provide the drug retail price
list to any person upon request.
The list provided by the board shall be prepared at least
annually by the board and distributed to each pharmacy in
the state. The list shall be a compendium of the one hundred
fifty most frequently prescribed drugs together with their
usual dosages for which a prescription is required by the
provisions of the "Federal Food, Drug,and Cosmetic Act" (21
U.S.C. 301, et seq.; 52 Stat. 1040, et seq.), as amended,
or by the commissioner of health. The board shall make the
compendium list available to each pharmacy free of charge,
both in printed form and in an electronic form that can be
used to produce the pharmacy's drug retail list. The board
shall provide the compendium list to the department of health.
The drug retail price list shall contain an advisory statement
by the department alerting consumers to the need to tell
their health care practitioner and pharmacist about all the
medications they may be taking and to ask them how to avoid
harmful interactions between drugs, if any. A pharmacy may
include on its drug retail price list a statement:
concerning discounts from its listed retail prices
that may be available to consumers and
any limitations that the pharmacy may have as to what
group or groups of customers it serves.
The pharmacy`s corresponding retail price means the actual
price to be paid by a retail purchaser to the pharmacy for any
listed drug at the listed dosage. However, upon implementation
of the prescription drug retail price list database by the department
of health under section two hundred seventy-six-a of the public
health law, the pharmacy's corresponding retail price shall mean
the price sent to it by the department of health under that section.
Pharmacies shall have a sign notifying people of the availability
of the drug retail price list and the availability of the department
of health prescription drug retail price list database and the
web address of that database, conspicuously posted at or adjacent
to the place in the pharmacy where prescriptions are presented
for compounding and dispensing, in the waiting area for customers,
or in the area where prescribed drugs are delivered.
Nothing contained herein shall prevent a pharmacy from changing
and charging the current retail price at any time, provided that
the listed price is updated at least weekly to reflect the new
The commissioner shall make regulations necessary to implement
this section, including how this section is applied to mail-order
and internet pharmacies.
§6826-a. Reducing certain copayments.
Where an insured's copayment for a drug exceeds the corresponding retail price for the same drug on the pharmacy's drug retail price list, the pharmacist shall notify the insured of this occurrence and charge no greater than the pharmacy's corresponding retail price.
Where the drug being purchased is not on the drug retail price list, and the copayment for the drug exceeds the pharmacy's usual and customary price for that drug, the pharmacist shall notify the insured of this occurrence and charge the lesser of the insured's copayment and the pharmacy's usual and customary price for that drug.
§6827. Mandatory continuing
pharmacist required under article one hundred thirty of this chapter to
register triennially with the department to practice in the state shall
comply with provisions of the mandatory continuing education
requirements prescribed in subdivision two of this section except as set
forth in paragraphs (b) and (c) of this subdivision. Pharmacists who do
not satisfy the mandatory continuing education requirements shall not
practice until they have met such requirements, and they have been
issued a registration certificate, except that a pharmacist may practice
without having met such requirements if he or she is issued a
conditional registration certificate pursuant to subdivision three of
In accord with the intent of this section, adjustment to the
mandatory continuing education requirement may be granted by the
department for reasons of health certified by an appropriate health care
professional, for extended active duty with the armed forces of the
United States, or for other good cause acceptable to the department
A licensed pharmacist not engaged in practice as determined by the
department, shall be exempt from the mandatory continuing education
such status. Any licensee who returns to the practice of pharmacy during
the triennial registration period shall notify the department prior to
reentering the profession and shall meet such mandatory education
requirements as shall be prescribed by regulations of the commissioner.
* During each triennial registration period an applicant for
registration shall complete a minimum of forty-five hours of acceptable
formal continuing education, as specified in subdivision four of this
section, provided that no more than twenty-two hours of such continuing
education shall consist of self-study courses. Any pharmacist participating in collaborative drug therapy management pursuant to section six thousand eight hundred one-a of this article shall complete at least five hours of acceptable formal continuing education in the area or areas of practice generally related to any collaborative drug therapy management protocols to which the pharmacist may be subject. Any pharmacist whose
first registration date following the effective date of this section
occurs less than three years from such effective date, but on or after
January first, nineteen hundred ninety-eight, shall complete continuing
education hours on a prorated basis at the rate of one and one-quarter
hours per month for the period beginning January first, nineteen hundred
ninety-seven up to the first registration date thereafter. A licensee
who has not satisfied the mandatory continuing education requirements
shall not be issued a triennial registration certificate by the
department and shall not practice unless and until a conditional
registration certificate is issued as provided for in subdivision three
of this section. Continuing education hours taken during one triennium
* NB Effective until September 14, 2015
registration to a licensee who fails to meet the continuing education
requirements established in subdivision two of this section but who
which the department may require. The fee for such a conditional
licensee who is notified of the denial of registration for failure to
submit evidence, satisfactory to the department, of required continuing
education and who practices pharmacy without such registration, may be
subject to disciplinary proceedings pursuant to section sixty-five
hundred ten of this chapter.
As used in subdivision two of this section, "acceptable formal
continuing education" shall mean formal courses of learning which
contribute to professional practice in pharmacy and which meet the
standards prescribed by regulations of the commissioner. The department
may, in its discretion and as needed to contribute to the health and
welfare of the public, require the completion of continuing education
courses in specific subjects. To fulfill this mandatory continuing
education requirement, courses must be taken from a sponsor approved by
the department, pursuant to the regulations of the commissioner.
Pharmacists shall maintain adequate documentation of completion of
acceptable formal continuing education and shall provide such
documentation at the request of the department. Failure to provide such
documentation upon the request of the department shall be an act of
misconduct subject to disciplinary proceedings pursuant to section
sixty-five hundred ten of this chapter.
The mandatory continuing education fee shall be forty-five dollars,
shall be payable on or before the first day of each triennial
registration period, and shall be paid in addition to the triennial
registration fee required by section sixty-eight hundred five of this
* §6828. Certificates of administration.
No pharmacist shall administer immunizing agents without a
certificate of administration issued by the department pursuant
The fee for a certificate of administration shall be one hundred
dollars and shall be paid on a triennial basis. A certificate
may be suspended or revoked in the same manner as a license to
practice pharmacy. * NB Effective until March 31, 2016
§6829. Interpretation and translation requirements for prescription drugs and standardized medication labeling.
For the purposes of this section, the following terms shall have the following meanings: "Covered pharmacy" means any pharmacy that is part of a group of eight or more pharmacies, located within New York state and owned by the same corporate entity. For purposes of this section, "corporate entity" shall include related subsidiaries, affiliates, successors, or assignees doing business as or operating under a common name or trading symbol.
"Limited English proficient individual" or "LEP individual" means an individual who identifies as being, or is evidently, unable to speak, read or write English at a level that permits such individual to understand health-related and pharmaceutical information communicated in English.
"Translation" shall mean the conversion of a written text from one language into an equivalent written text in another language by an individual competent to do so and utilizing all necessary pharmaceutical and health-related terminology. Such translation may occur, where appropriate, in a separate document provided to an LEP individual that accompanies his or her medication.
"Competent oral interpretation" means oral communication in which a person acting as an interpreter comprehends a message and re-expresses that message accurately in another language, utilizing all necessary pharmaceutical and health-related terminology, so as to enable an LEP individual to receive all necessary information in the LEP individual's preferred pharmacy primary language.
"Pharmacy primary languages" shall mean those languages spoken by one percent or more of the population, as determined by the U.S. Census, for each region, as established by regulations promulgated pursuant to this section, provided, however, that the regulations shall not require translation or competent oral interpretation of more than seven languages in any region.
"Mail order pharmacy" shall mean a pharmacy that dispenses most of its prescriptions through the United States postal service or other delivery system.
Every covered pharmacy shall provide free, competent oral interpretation services and translation services to each LEP individual requesting such services or filling a prescription that indicates that the individual is limited English proficient at such covered pharmacy in the LEP individual's preferred pharmacy primary language for the purposes of counseling such individual about his or her prescription medications or when soliciting information necessary to maintain a patient medication profile, unless the LEP individual is offered and refuses such services.
Every covered pharmacy shall provide free, competent oral interpretation services and translation services of prescription medication labels, warning labels and other written material to each LEP individual filling a prescription at such covered pharmacy, unless the LEP individual is offered and refuses such services or the medication label, warning labels and other written materials have already been translated into the language spoken by the LEP individual.
The services required by this section may be provided by a staff member of the pharmacy or a third-party contractor. Such services must be provided on an immediate basis but need not be provided in-person or face-to-face in order to meet the requirements of this section.
Every covered pharmacy shall conspicuously post, at or adjacent to each counter over which prescription drugs are sold, a notification of the right to free, competent oral interpretation services and translation services for limited English proficient individuals as provided for in subdivision two of this section. Such notifications shall be provided in the pharmacy primary languages. The size, style and placement of such notice shall be determined in accordance with rules promulgated pursuant to this section.
The commissioner, in consultation with the commissioner of health, shall promulgate regulations requiring that mail order pharmacies conducting business in the state provide free, competent oral interpretation services and translation services to persons filling a prescription through such mail order pharmacies whom are identified as LEP individuals. Such regulations shall take effect one year after the effective date of this section; provided, however, that they shall be promulgated pursuant to the requirements of the state administrative procedure act, address the concerns of affected stakeholders, and reflect the findings of a thorough analysis of issues including:
how persons shall be identified as an LEP individual, in light of the manner by which prescriptions are currently received by such mail order pharmacies;
which languages shall be considered;
the manner and circumstances in which competent oral interpretation services and translation services shall be provided;
the information for which competent oral interpretation services and translation services shall be provided;
anticipated utilization, available resources, and cost considerations; and
standards for monitoring compliance with regulations and ensuring the delivery of quality competent oral interpretation services and translation services.
The commissioner, in consultation with the commissioner of health, shall provide a report on implementation, utilization, unanticipated problems, and corrective actions undertaken and planned to the temporary president of the senate and the speaker of the assembly no later than two years after the effective date of this section.
Covered pharmacies shall not be liable for injuries resulting from the actions of third-party contractors taken pursuant to and within the scope of the contract with the covered pharmacy as long as the covered pharmacy entered into such contract reasonably and in good faith to comply with this section, and was not negligent with regard to the alleged misconduct of the third-party contractor.
The regulations promulgated pursuant to this section shall establish a process by which covered pharmacies may apply and receive a waiver from compliance with subdivisions two and three of this section upon a showing that implementation would be unnecessarily burdensome when compared to the need for such services.
The commissioner shall promulgate regulations in consultation with the commissioner of health to effectuate the requirements of this section.
§6830. Standardized patient-centered data elements.
The commissioner shall develop rules and regulations requiring standardized patient-centered data elements consistent with existing technology and equipment to be used on all prescription medicine dispensed to patients in this state.	When developing the requirements for patient-centered data elements on prescription drug labels, the commissioner shall consider:
medical literacy research that identifies factors that improve understandability of labels and promotes increased compliance with a drug's intended use;
factors that improve the clarity of directions for use;
font types and sizes;
inclusion of only patient-centered information; and
the needs of special populations.
To ensure public input, the commissioner shall solicit input from the state board of pharmacy and the state board of medicine, consumer groups, advocates for special populations, pharmacists, physicians, other health care professionals authorized to prescribe, and other interested parties.
§6831. Special provisions relating to outsourcing facilities.
Registration. Any outsourcing facility that is engaged in the
compounding of sterile drugs in this state shall be registered as an
outsourcing facility under the Federal Food, Drug and Cosmetic Act and
be registered as an outsourcing facility pursuant to this article.
New drugs. Sections 502(f)(1), 505 and 582 of the Federal Food,
Drug and Cosmetic Act shall not apply to a drug compounded in an
outsourcing facility registered under the Federal Food, Drug and
Prescriptions. Notwithstanding any other provision of law to the
contrary, no outsourcing facility may distribute or dispense any drug to
any person pursuant to a prescription unless it is also registered as a
pharmacy in this state and meets all other applicable requirements of
Restrictions. Any drugs compounded in an outsourcing facility
registered pursuant to this article shall be compounded in accordance
with all applicable federal and state laws.
Labeling. Notwithstanding any other provision of law to the
contrary, the label of any drug compounded by an outsourcing facility
a statement that the drug is a compounded drug or a reasonable
comparable alternative statement that prominently identifies the drug as
a compounded drug;
the name, address, and phone number of the applicable outsourcing
with respect to the drug:
the statement that the drug is not for resale, and the statement
"Office Use Only"; and
a list of the active and inactive ingredients, identified by
established name, and the quantity or proportion of each ingredient.
Container. The container from which the individual units of the
drug are removed for dispensing or for administration (such as a plastic
bag containing individual product syringes) shall include:
a list of active and inactive ingredients, identified by
established name, and the quantity or proportion of each ingredient; and
any other information required by regulations promulgated by the
commissioner to facilitate adverse event reporting in accordance with
the requirements established in section 310.305 of title 21 of the code
Bulk drugs. A drug may only be compounded in an outsourcing
facility that does not compound using bulk drug substances as defined in
section 207.3(a)(4) of title 21 of the code of federal regulations or
any successor regulation unless:
the bulk drug substance appears on a list established by the
secretary of health and human services identifying bulk drug substances
for which there is a clinical need;
the drug is compounded from a bulk drug substance that appears on
the federal drug shortage list in effect at the time of compounding,
distributing, and dispensing;
if an applicable monograph exists under the United States
Pharmacopeia, the national formulary, or another compendium or
pharmacopeia recognized by the secretary of health and human services
and the bulk drug substances each comply with the monograph;
the bulk drug substances are each manufactured by an establishment
that is registered with the federal government.
Ingredients. If an outsourcing facility uses ingredients, other
than bulk drug substances, such ingredients must comply with the
standards of the applicable United States pharmacopeia or national
formulary monograph, if such monograph exists, or of another compendium
or pharmacopeia recognized by the secretary of health and human services
for purposes of this subdivision, if any.
Unsafe or ineffective drugs. No outsourcing facility may compound a
drug that appears on a list published by the secretary of health and
human services that has been withdrawn or removed from the market
because such drugs or components of such drugs have been found to be
unsafe or not effective.
Prohibition on wholesaling. No compounded drug will be sold or
transferred by any entity other than the outsourcing facility that
compounded such drug. This does not prohibit the administration of a
drug in a health care setting or dispensing a drug pursuant to a
properly executed prescription.
Prohibition against copying an approved drug. No outsourcing
facility may compound a drug that is essentially a copy of one or more
Prohibition against compounding drugs presenting demonstrable
difficulties. No outsourcing facility may compound a drug:
that is identified, directly or as part of a category of drugs, on
a list published by the secretary of health and human services that
present demonstrable difficulties for compounding that are reasonably
likely to lead to an adverse effect on the safety or effectiveness of
the drug or category of drugs, taking into account the risks and
benefits to patients; or
that is compounded in accordance with all applicable conditions
identified on the drug list as conditions that are necessary to prevent
the drug or category of drugs from presenting demonstrable difficulties.
Adverse event reports. Outsourcing facilities shall submit a copy
of all adverse event reports submitted to the secretary of health and
human services in accordance with the content and format requirements
established in section 310.305 of title 21 of the code of federal
regulations, or any successor regulation, to the executive secretary for
Reports. The commissioner, in consultation with the commissioner
of health, shall prepare and submit a report to the governor and the
legislature, due eighteen months from the effective date of this
section, evaluating the effectiveness of the registration and oversight
of outsourcing facilities related to compounding.