Education Law §6800
 
Introduction
 
 
📝 Clear, Concise Summary
 
•  This article governs the profession of pharmacy.
•  All the general rules that apply to every licensed profession in New York (found in Article 130) also apply to pharmacy.
•  In practice, this means pharmacy follows both its specific rules and the universal professional standards set for all professions.
 
🔍 What This Means for Pharmacy Professionals
 
•  Dual applicability:
  ⁠◦  Pharmacy has its own dedicated article with profession‑specific requirements.
  ⁠◦  But pharmacists are also bound by the general licensing, conduct, and enforcement provisions that apply to all NYS professions.
•  Examples of Article 130 provisions that apply:
  ⁠◦  Licensing and registration rules
  ⁠◦  Professional misconduct definitions
  ⁠◦  Unauthorized practice prohibitions
 
 
This summary page was last updated April 4, 2026
 
Education Law §6801
 
Definition of practice of pharmacy
 
🧭 Summary of NY Pharmacy Practice & Expanded Authorities
 
🧪 Definition of Pharmacy Practice
 
The practice of pharmacy includes:
 
•  Administering, preparing, compounding, preserving, and dispensing drugs, medicines, and therapeutic devices
•  Acting on prescriptions or other legal authority
•  Performing collaborative drug therapy management under §6801‑a
 
💉 Pharmacist Immunization Authority
 
Non–Patient-Specific Orders
 
A pharmacist may administer immunizations under a non‑patient‑specific order from a NY‑licensed physician or nurse practitioner.
 
When Administering an Immunization, the Pharmacist Must:
 
•  Report the immunization to:
  ⁠◦  The patient’s primary care practitioner (if any)
  ⁠◦  NYSIIS or CIR (as permitted under PBH §2168)
•  Provide DOH‑developed information on the importance of having a primary care practitioner
•  Report administration to DOH without identifiable patient information
•  Inform the patient of total cost before administration, including:
  ⁠◦  Insurance coverage
  ⁠◦  Notice that coverage may differ if administered by a primary care provider
•  Follow ACIP recommendations, unless a patient‑specific order authorizes otherwise
 
Training Requirement
 
Pharmacists must complete DOH‑approved training before administering:
 
•  Immunizations
•  Injectable medications for mental health or substance use disorder treatment
 
Training must include screening, consent, administration technique, contraindications, recordkeeping, and emergency management.
 
Privacy Area Requirements
 
When immunizing in a pharmacy, the area must include:
 
•  A visible posting of the current ACIP Adult Immunization Schedule
•  Educational materials on influenza vaccination for children
 
🧬 HIV Post‑Exposure Prophylaxis (PEP)
 
Pharmacists may dispense up to a 7‑day starter pack of HIV PEP under a non‑patient‑specific order issued by a NY physician or NP, following DOH regulations.
 
💉 Emergency Insulin Refills (Non‑Patient‑Specific Order)
 
A pharmacist may dispense up to a 30‑day emergency supply of insulin and related supplies when:
 
1.  The patient has a valid prescription that expired within the last 12 months
2.  The pharmacist attempts but cannot reach the prescriber
3.  The prescriber does not object
4.  The pharmacist notifies the prescriber within 72 hours
 
🧪 Limited Service Laboratory Authority (Temporary)
 
Until July 1, 2026:
Pharmacists are considered qualified health care professionals for:
 
•  Directing a limited service lab
•  Ordering/administering FDA‑authorized COVID‑19 and influenza tests
(Subject to CLIA waiver requirements)
 
🧠 Injectable Medications for Mental Health & Substance Use Disorder
 
Pharmacists may administer injectable medications for MH/SUD treatment:
 
•  Under a patient‑specific prescription
•  Within their lawful scope
•  In accordance with DOH and other agency regulations
 
🌸 Self‑Administered Hormonal Contraceptives
 
Pharmacists may dispense hormonal contraceptives under a non‑patient‑specific order.
Before dispensing (and at least every 12 months for returning patients), pharmacists must:
 
1. Provide and review a DOH‑developed self‑screening questionnaire
 
To identify risk factors and guide product selection.
 
2. Provide a DOH‑developed fact sheet
 
Including:
 
•  Clinical considerations
•  Instructions for use
•  Importance of follow‑up care
•  Referral information
•  Patient’s right to opt out of practitioner notification
 
Training Requirement
 
Pharmacists must complete DOH‑approved training before participating.
 
Notification Requirement
 
Within 72 hours, pharmacists must notify the patient’s primary care practitioner unless the patient opts out.
If the patient has no PCP, the pharmacist must:
 
•  Provide a written record of the contraceptive dispensed
•  Advise the patient to consult a health care practitioner
 
Professional Judgment Clause
 
Pharmacists may refuse to dispense under the non‑patient‑specific order if clinical concerns exist.
 
This summary page was last updated March 30, 2026
 
 

 
Education Law §6801-a
 
Collaborative drug therapy management demonstration program
 
📘 Summary of Collaborative Drug Therapy Management (CDTM) Provisions
 
🔹 Key Definitions
 
•  Board: The NY State Board of Pharmacy. 
•  Clinical services: Collecting/interpreting patient data to initiate, modify, or monitor drug therapy in direct patient care. 
•  Collaborative Drug Therapy Management: Pharmacist‑performed clinical services under a written agreement/protocol with a voluntarily participating physician for a specific disease. Activities may include:
  ⁠◦  Adjusting drug strength, frequency, or route but not changing to a different drug unless explicitly authorized.
  ⁠◦  Ordering disease‑related labs only if the protocol authorizes it.
  ⁠◦  Performing routine monitoring (vitals, histories) only if authorized. 
 
🔹 Facility Requirements
 
CDTM may occur only in:
 
•  Teaching or general hospitals, including hospital‑based outpatient departments; or
•  Nursing homes with an on‑site pharmacy staffed by a pharmacist.
Dental clinics, RHCFs, and rehab centers are excluded. 
 
🔹 Physician Requirements
 
•  Must be the patient’s treating physician for the disease involved.
•  Must be employed by or affiliated with the same facility as the pharmacist.
•  Physician judgment always prevails; pharmacists cannot diagnose. 
 
🔹 Written Agreement or Protocol
 
Must:
 
•  Address a specific disease or disease states.
•  Define the scope of CDTM services.
•  Comply with all state/federal requirements.
 
🔹 Pharmacist Eligibility
 
A pharmacist must be employed by/affiliated with the facility and meet one of the following:
 
Pathway 1: Advanced Degree
 
•  Master’s in clinical pharmacy or PharmD
•  Unrestricted license
•  2 years experience, including 1 year clinical experience involving physician consultation (residency may count). 
 
Pathway 2: Bachelor’s Degree
 
•  B.S. in pharmacy
•  Unrestricted license
•  3 years experience within the last 7 years, including 1 year clinical experience involving physician consultation (residency may count).
•  Must meet any additional requirements set by the department/board. 
 
Supervised Experience Clause
 
Pharmacists may perform CDTM‑related clinical services under supervision to gain required experience, if authorized in the protocol.
 
🔹 Patient A Consent & Disclosure
 
•  CDTM may only occur with written patient (or representative) consent.
•  Consent and withdrawal must be documented in the medical record.
•  The existence of the protocol and patient consent must be disclosed to the patient’s primary and other treating providers.
•  Participation is voluntary for all parties. 
 
🔹 Scope & Limitations
 
•  Does not limit existing pharmacy practice or medication management outside CDTM.
•  Does not authorize diagnosis.
•  Repeal date: July 1, 2026 (per statute).
 
 
This summary page was last updated April 4, 2026
 

 
Education Law §6802
 
Definitions
 
🏥 Core Definitions
 
Pharmacy
 
A pharmacy is any place where drugs, prescriptions, or poisons are kept, compounded, dispensed, preserved, retailed, or advertised for retail sale.
 
Formulary & Pharmacopeias
 
•  Formulary: The current Official National Formulary and its supplement.
•  Pharmacopeia: The current United States Pharmacopeia (USP) and supplement.
•  Homeopathic Pharmacopeia: The official U.S. Homeopathic Pharmacopeia and supplement.
•  Official Compendium: USP, Homeopathic Pharmacopeia, National Formulary, and their supplements.
 
 
 
 
 
 
💊 Drugs, Cosmetics, Poisons
 
Drugs
 
Includes:
 
•  Articles recognized in the USP, Homeopathic Pharmacopeia, or National Formulary.
•  Articles intended for diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.
•  Articles (not food) intended to affect body structure or function.
•  Components of the above.
Excludes: devices and their parts.
 
Cosmetics
 
•  Articles applied to the human body for cleansing, beautifying, or altering appearance.
•  Components of such articles.
Excludes: soap.
 
Poison
 
Any drug, chemical, or preparation likely to be lethal to an adult human in quantities of 60 grains or less.
 
🏷️ Labeling & Misbranding
 
Label
 
Information printed on the immediate container. Required information must also appear on or be visible through the outer retail package.
 
Immediate Container
 
Does not include package liners.
 
Labeling
 
All written, printed, or pictorial matter:
 
•  On the drug/device/cosmetic or its containers/wrappers
•  Or accompanying it
 
Misbranding
 
Labeling or advertising is misleading if:
 
•  It contains false or misleading representations, or
•  It fails to reveal material facts, including risks under customary use.
 
Products compliant with federal FD&C Act misbranding/adulteration rules are not considered misbranded under state law where state rules conflict.
 
Antiseptic
 
Labeling a product as an antiseptic implies it is a germicide, except when used for inhibitory purposes (e.g., wet dressings, ointments, powders with prolonged contact).
 
🧪 New Drugs & Devices
 
New Drug
 
A drug is “new” if:
 
•  It is not generally recognized by qualified experts as safe and effective under labeled conditions; unless it was marketed before Sept. 1, 1939 with the same labeled uses; or
•  It has become recognized only through investigations and has not been used to a material extent outside those investigations.
 
Device
 
Instruments or apparatus (including components) intended:
 
•  For diagnosis, cure, mitigation, treatment, or prevention of disease; or
•  To affect body structure or function.
 
🏛️ Other Key Terms
 
Federal Food, Drug, and Cosmetic Act
 
The 1938 federal law (and amendments) governing drug, device, and cosmetic safety, labeling, and adulteration.
 
Wholesaler
 
A person who bottles, packs, or purchases drugs/devices/cosmetics for resale to pharmacies or other authorized channels.
 
Manufacturer
 
A person who compounds, mixes, prepares, produces, bottles, or packs drugs/cosmetics/devices for distribution or sale.
 
Advertisement
 
Any representation (other than labeling) intended to induce purchase of drugs, devices, or cosmetics.
 
Controlled Substance
 
Any drug defined as such under Public Health Law Article 33.
 
🩺 Summary of Key Definitions (NY Education Law §6801 context)
 
1. “Administer” — What pharmacists are legally allowed to apply directly
 
A. Adults (18+)
 
Pharmacists may directly apply an immunizing agent by any route (injection, ingestion, inhalation, etc.) under a patient‑specific order or non‑patient‑specific regimen for:
 
•  Routine vaccines: influenza, pneumococcal, shingles, hepatitis A/B, HPV, MMR, varicella, COVID‑19, meningococcal, tetanus, diphtheria, pertussis.
•  Emergency anaphylaxis treatment.
•  Additional ACIP‑recommended adult vaccines if the NY Health Commissioner determines:
  ⁠◦  They can be safely administered by pharmacists and
  ⁠◦  They are needed to prevent a prevalent reportable communicable disease, or
  ⁠◦  The patient meets ACIP criteria (age, no documentation, no immunity, risk factors).
 
Statewide non‑patient‑specific orders may be issued during an outbreak or imminent threat.
 
B. Children (Ages 2–18)
 
Pharmacists may administer:
 
•  Influenza vaccine, and
•  Emergency anaphylaxis treatment related to that vaccination,
under patient‑specific or non‑patient‑specific orders.
 
A statewide non‑patient‑specific order may be issued during an influenza outbreak or imminent threat.
 
C. Mental Health & Substance Use Disorder Injections
 
Pharmacists may inject FDA‑approved medications for MH/SUD treatment when:
 
•  There is a valid patient‑specific prescription/order authorizing pharmacist administration.
•  The pharmacist notifies the prescriber within 5 days of administration (or if missed, or if adverse effects occur) via EMR, e‑prescribing tech, pharmacy record, fax, electronic means, or phone if necessary.
•  Initial dose must be given elsewhere; pharmacy administration begins only once the prescriber deems the patient eligible for maintenance therapy.
•  Activity follows DOH‑consulted regulations requiring:
  ⁠◦  Ongoing competency,
  ⁠◦  Pre‑administration consent & education,
  ⁠◦  Privacy‑appropriate injection area,
  ⁠◦  Use of FDA‑approved medications only.
 
2. “Electronic prescription”
 
A prescription that is:
 
•  Created, signed, and transmitted electronically,
•  Using an electronic signature (sound, symbol, or process attached to the record),
•  In compliance with state and federal regulations.
 
A hard‑copy prescription created electronically may be faxed, but must be manually signed.
 
3. “Compounding”
 
Combining, mixing, diluting, reconstituting, or otherwise altering a drug or bulk drug substance to create a drug in relation to a 503B outsourcing facility, as further defined in statute.
 
4. “Outsourcing facility”
 
A facility that:
 
•  Compounds sterile drugs,
•  Is registered with HHS as an outsourcing facility,
•  Complies with all applicable federal and state law.
 
5. “Sterile drug”
 
A drug intended for:
 
•  Parenteral use,
•  Ophthalmic use,
•  Oral inhalation (aqueous),
•  Or otherwise required to be sterile.
 
6. “Biological product” & “Interchangeable biological product”
 
•  Biological product: As defined in 42 U.S.C. §262(i).
•  Interchangeable biological product: FDA‑licensed under §262(k)(4) or FDA‑designated as therapeutically equivalent (Purple Book / Orange Book references).
 
7. “Self‑administered hormonal contraceptives”
 
FDA‑approved hormonal contraceptive oral tablets, patches, and vaginal rings used to prevent pregnancy by regulating or preventing ovulation.
 
 
This summary page was last updated April 4, 2026
 
Education Law §6803
 
Practice of pharmacy and use of title “pharmacist”
 
📘 Clear Summary
 
•  The law restricts both the practice of pharmacy and the title “pharmacist.”
•  No one may engage in pharmacy activities or use the title (or any variation of it) unless they hold a valid license or are explicitly authorized under the same article of law. 
 
🔍 What This Means in Practice
 
•  Protected title: “Pharmacist,” “RPh,” or any derivative cannot be used by unlicensed individuals.
•  Protected activities: Compounding, dispensing, preparing, or administering medications are legally limited to those authorized under Article 137.
•  Purpose: This prevents misrepresentation and protects the public by ensuring only qualified professionals provide pharmacy services.
 
 
This summary page was last updated April 4, 2026
 

 
Education Law §6804
 
State board of pharmacy
 
 
🏛️ Board Structure
 
•  Appointed by: The Board of Regents, based on the Commissioner’s recommendation.
•  Purpose: To assist with professional licensing and professional conduct matters.
•  Composition:
  ⁠◦  At least 9 pharmacists licensed in NY for 5+ years.
  ⁠◦  2 registered pharmacy technicians.
  ⁠◦  Initial technician members don’t need to be licensed yet, but must meet all other licensure requirements except filing an application and paying the fee.
•  Executive Secretary:
  ⁠◦  Appointed by the Regents on the Commissioner’s recommendation.
  ⁠◦  Must be a NY‑licensed pharmacist for at least 5 years.
 
📌 Core Responsibilities
 
The Board assists the Department with:
 
•  Regulating the practice of pharmacy, including:
  ⁠◦  Pharmacists
  ⁠◦  Registered pharmacy technicians
  ⁠◦  Interns and other pharmacy employees
•  Regulating and controlling the sale, distribution, and standards of:
  ⁠◦  Drugs
  ⁠◦  Poisons
  ⁠◦  Cosmetics
  ⁠◦  Devices
  ⁠◦  New drugs
•  Preventing the sale or distribution of any such items that violate pharmacy law or the Public Health Law.
•  Investigating alleged violations of Article 137.
•  Issuing limited permits or registrations.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6805
 
Requirements of a professional license
 
📘 New York Pharmacist Licensure Requirements
 
🧾 Core Requirements
 
To qualify for a New York State pharmacist license, an applicant must meet all of the following:
 
1. Application
 
•  Submit a formal application to the NYS Education Department.
 
2. Education
 
•  Complete an approved pharmacy education program, including a bachelor’s degree or equivalent, consistent with the Commissioner’s regulations.
 
3. Experience
 
•  Fulfill practical experience requirements acceptable to the State Board of Pharmacy and defined in regulation.
 
4. Examination
 
•  Pass all examinations required by the Board and the Commissioner’s regulations.
 
5. Age
 
•  Must be at least 21 years old.
 
6. Citizenship / Immigration Status
 
•  Must be a U.S. citizen or a lawful permanent resident.
 
7. Character
 
•  Must demonstrate good moral character, as determined by the Department.
 
8. Fees
 
•  $175 — Admission to a department‑conducted exam and initial license
•  $85 — Each re‑examination
•  $115 — Initial license for applicants not requiring a department‑conducted exam
•  $155 — Each triennial registration period
 
🕰️ Historical Provision (Grandfathering Clause)
 
•  Before April 1, 1972, any individual holding a valid New York license as a “druggist” could apply and, upon paying the required fees, be licensed as a pharmacist.
•  These individuals received full rights, privileges, duties, and responsibilities of a pharmacist.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6806
 
Limited permits
 
🎓 Who Can Get a Limited (Intern) Permit
 
•  Students in the last two years of a registered pharmacy program.
•  Graduates of qualifying pharmacy programs who are:
  ⁠◦  Completing required experience, or
  ⁠◦  Have a pending licensure application.
 
🧑‍⚕️ Scope of Practice for Pharmacy Interns
 
•  May practice as a pharmacist only under immediate personal supervision of a licensed pharmacist.
•  May obtain a certificate to administer immunizations if they meet training requirements.
 
💉 Immunization Certification Requirements
 
To administer vaccines, an intern must complete training approved by the Commissioner and the Commissioner of Health, including:
 
•  Screening & informed consent
•  Administration techniques
•  Indications, precautions, contraindications
•  Recordkeeping
•  Emergency management (e.g., anaphylaxis, needlestick injuries)
 
They must also submit documentation from their program dean confirming completion of required training.
 
🧭 Supervision During Immunization
 
•  Even when certified, an intern may administer vaccines only under immediate personal supervision of a pharmacist who is also certified to immunize.
•  Patients must be informed:
  ⁠◦  That a certified intern will administer the vaccine, and
  ⁠◦  That they may choose to receive it from a certified pharmacist instead.
 
📅 Permit Duration & Renewal
 
•  Valid for 5 years from issuance.
•  May be renewed once, for up to 2 additional years.
 
💵 Fees
 
•  $70 per limited intern permit
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6807
 
Exempt persons; special provisions
 
📘 Summary of Exceptions to Pharmacy Practice Restrictions
 
This section clarifies what activities are not restricted by the pharmacy practice article
 
🧑‍⚕️ 1. Activities Allowed Without a Pharmacy License
 
•  Unlicensed assistants may work in a pharmacy as long as they do not practice pharmacy.
•  Prescribers such as physicians, dentists, veterinarians, NPs, etc. who do not own or work for a pharmacy may:
  ⁠◦  Supply drugs directly to their own patients.
  ⁠◦  Must label containers with:
      •  Dispenser name/address
    •  Patient name
    •  Directions
    •  Date of delivery
    •  Drug name and strength (unless the prescriber handwrites an instruction to omit it)
  ⁠◦  Controlled substances must follow Public Health Law Article 33.
 
Special rule:
 
•  Labels for mifepristone or misoprostol may list the health care practice instead of the individual dispenser.
 
🛒 2. Merchants
 
•  May sell non‑poisonous, non‑habit‑forming proprietary medicines and items exempted by DOH or Public Health Law.
 
🧪 3. Academic Institutions
 
•  Colleges/universities may use prescription‑only drugs on premises for:
  ⁠◦  Research
  ⁠◦  Experiments
  ⁠◦  Instruction
•  Controlled substances must follow Article 33, Title III.
 
🏭 4. Manufacturers & Wholesalers
 
•  May conduct their ordinary business activities, subject to Article 33.
 
⏱️ 5. Limits on Prescriber Dispensing (72‑hour rule)
 
Prescribers who do not own or work for a pharmacy may not dispense more than a 72‑hour supply, except for:
 
•  Hospital practitioners
•  Drugs dispensed at no charge
•  Practices 10+ miles from a registered pharmacy
•  College/university clinics, infirmaries, health services
•  Professionals licensed under Article 135 (optometrists)
•  Medical emergencies
•  Drugs diluted, reconstituted, or compounded by the prescriber
•  Allergenic extracts
•  Drugs dispensed under oncology or AIDS protocols
 
The commissioner may create additional renewable one‑year exemptions by regulation.
 
💉 6. Non‑Patient‑Specific Orders for Nurses
 
•  Pharmacists may dispense drugs/devices to registered professional nurses.
•  Nurses may possess/administer them under a non‑patient‑specific regimen ordered by:
  ⁠◦  A physician
  ⁠◦  A certified nurse practitioner
•  Must follow DOH and Education Department regulations.
 
This summary page was last updated April 5, 2026
 

 
Education Law §6808
 
Registering and operating establishments
 
🏥 Pharmacy Registration & Operation – Summary
 
🔒 Who Must Register
 
•  No person or business may possess or sell drugs, prescriptions, or poisons for compounding, dispensing, retailing, wholesaling, or manufacturing unless registered as a:
  ⁠◦  Pharmacy
  ⁠◦  Wholesaler
  ⁠◦  Manufacturer
  ⁠◦  Outsourcing facility
 
📝 Pharmacy Registration Requirements
 
🧾 Applying for Registration
 
•  Application must be submitted on department forms.
•  Initial fee: $345.
•  Pharmacy must maintain adequate facilities, equipment, and drug stock to ensure prompt and efficient dispensing.
 
🔄 Renewal
 
•  Renewed on department‑set dates.
•  Triennial renewal fee: $260 (or prorated).
•  Owner must report required information under oath at renewal.
 
📜 Display Requirements
 
•  Registration must be conspicuously displayed at all times.
•  Owner names must be displayed on the exterior—this serves as presumptive evidence of ownership.
•  If the owner is not a pharmacist, the registration must also list the supervising pharmacist.
•  Any change in supervising pharmacist requires:
  ⁠◦  Notification to the department
  ⁠◦  Application for an amended registration
  ⁠◦  Display of the amended registration alongside the original
•  Both owner and supervising pharmacist share responsibility for compliance.
 
📍 Changes in Location
 
•  Owner must request inspection and endorsement for a new location.
•  Fee: $50, unless the move is temporary due to disaster (fire, flood, etc.).
 
🧪 Conduct of a Pharmacy
 
•  Owner is responsible for strength, quality, purity, and labeling of all drugs and related products.
•  Pharmacy must be under the immediate supervision of a licensed pharmacist whenever open.
•  A pharmacist may not supervise more than one pharmacy at a time.
 
🛒 Pharmacy as a Department in a Larger Store
 
•  Pharmacy area must be physically separated so it is inaccessible when no pharmacist is on duty.
•  Use of terms like “pharmacy,” “drug store,” “drugs,” “medicines” is restricted to the licensed area only.
 
🏥 Limited Pharmacy Registration
 
For Hospitals, Nursing Homes, Extended Care Facilities
 
•  Department may waive requirements (full‑time pharmacist, minimum space/equipment, waiting area) if:
  ⁠◦  Patient safety remains high
  ⁠◦  Services are limited to furnishing drugs to registered inpatients
 
For Dialysis Solution Distribution Facilities
 
•  Department may waive similar requirements.
•  Dispensing limited to dialysis solutions prescribed for ESRD patients.
•  Solutions may be dispensed by trained, proficiency‑verified employees under general pharmacist supervision.
•  Pharmacist remains responsible for distribution, labeling, recordkeeping, and delivery.
•  Department must issue regulations ensuring safe distribution, storage, and labeling.
•  Registration fee: $345 per triennial period.
 
 
👤 Applicant Character Requirements
 
•  Applicants must be of good moral character.
•  For corporations, this applies to:
  ⁠◦  Officers
  ⁠◦  Directors
  ⁠◦  Any stockholder with ≥10% ownership
 
🏭 Wholesalers, Manufacturers & Outsourcing Facilities – Summary
 
📋 Registration Requirements (Wholesalers & Manufacturers)
 
•  Application: Must use department‑prescribed forms.
•  Initial fee: $825.
•  Renewal: Every 3 years; $520 (or prorated).
•  Display: Registration must be conspicuously posted at the business.
•  Change of location:
  ⁠◦  Requires inspection and endorsement by the department.
  ⁠◦  Fee: $170, unless the move is temporary due to disaster.
 
🧪 Outsourcing Facility Registration
 
📝 Obtaining & Renewing Registration
 
•  Application (initial or renewal) must use department forms.
•  Initial fee: $825.
•  Triennial renewal fee: $520 (or prorated).
•  Registration must be conspicuously displayed.
 
📍 Change of Location
 
•  Requires department inspection and endorsement.
•  Fee: $175, unless temporary due to disaster.
 
📊 Semiannual Reporting Requirement
 
Every 6 months, outsourcing facilities must report:
 
•  All drugs compounded in the prior 6 months.
•  For each drug:
  ⁠◦  Active ingredient & its source
  ⁠◦  NDC of source drug or bulk ingredient (if available)
  ⁠◦  Strength per unit
  ⁠◦  Dosage form & route
  ⁠◦  Package description
  ⁠◦  Number of units produced
  ⁠◦  NDC of final product (if assigned)
 
🧑‍⚕️ Conduct & Oversight
 
•  Owner is responsible for strength, quality, purity, and labeling of all compounded drugs.
•  Facility must be under immediate supervision of a NY‑licensed pharmacist.
•  Applicants must be of good moral character; for corporations, applies to officers, directors, and ≥10% stakeholders.
 
🔍 Inspection Authority
 
•  The State Board of Pharmacy, Department of Education, and designated employees may inspect any pharmacy, wholesaler, manufacturer, outsourcing facility, or vehicle.
•  Inspections may include records, equipment, materials, containers, and labels.
 
⚖️ Penalties
 
•  All registered entities are under Board of Regents supervision.
•  Violations constitute professional misconduct and are subject to disciplinary action under Article 130.
 
🏷️ Sale of Drugs at Auction
 
•  Controlled substances, poisons, deleterious drugs, or bulk/open‑container drugs cannot be sold at auction unless:
  ⁠◦  The auction site is registered, and
  ⁠◦  A licensed pharmacist personally supervises the sale.
•  Open‑container drugs require a board inspection certificate.
•  Drugs requiring expiration dating cannot be sold if expired or expiring within 30 days.
 
🫁 Supervision Requirements for Wholesalers Transfilling Medical Oxygen
 
Supervisors must be one of the following:
 
•  A nationally certified respiratory therapist
•  A person with a bachelor’s degree in chemistry, microbiology, chemical engineering, or related field
•  A person with 2 years post‑high‑school education + 2 years experience with compressed medical gases
•  A person trained per 21 CFR 211.25
 
This summary page was last updated April 5, 2026
 
 
 
 
 
 

 
Education Law §6808-a
 
Identification of pharmacists
 
📘 Summary
 
Every pharmacist on duty must wear a state‑board‑designed badge that clearly displays their name and professional title.
 
This summary page was last updated April 5, 2026
 

 
Education Law §6808-b
 
Registration of nonresident establishments
 
📝 Definition
 
A nonresident establishment is any pharmacy, manufacturer, wholesaler, or outsourcing facility located outside New York that ships, mails, or delivers prescription drugs or devices to:
 
•  NY‑based establishments
•  Authorized prescribers
•  Patients residing in New York
 
Includes internet‑based pharmacies.
 
🏛️ Registration Requirement
 
All nonresident establishments shipping drugs/devices into NY must register with the department, except:
 
•  Intra‑company transfers between entities under complete common ownership.
 
This section applies only to nonresident establishments.
 
🧑‍⚖️ Agent of Record
 
Each nonresident establishment must appoint a New York resident agent for service of process.
 
📋 Conditions of Registration
 
Nonresident establishments must:
 
•  Be licensed/registered and in good standing in their home state
•  Maintain readily retrievable records of all drugs/devices shipped into NY
•  Provide information requested by the department
•  Follow home‑state laws for drugs/devices shipped into NY
•  For controlled substances, comply with federal law and New York law
•  Submit applications in the department‑prescribed form
•  Pay required fees:
  ⁠◦  Manufacturers/wholesalers/outsourcing facilities: fees per §6808
  ⁠◦  Nonresident pharmacies:
      •  Initial fee: $345
    •  Triennial renewal: $260
 
☎️ Additional Requirements for Nonresident Pharmacies
 
They must:
 
•  Provide a toll‑free phone number, available at least 40 hours/week, for NY patients to reach a pharmacist with access to their records
•  Place this toll‑free number on each drug/device label
 
⚖️ Disciplinary Action
 
NY will not take action against a nonresident establishment for violations if the home‑state agency begins enforcement within 120 days of the reported violation.
 
NY may act if:
 
•  The home state delays unreasonably
•  The home state fails to take appropriate action
 
⛔ Revocation or Suspension
 
Failure to comply may result in:
 
•  Suspension or revocation of registration
•  Other penalties under Article 130
 
🧩 Exception
 
The department may grant an exception for establishments that only conduct isolated transactions with NY residents.
 
🛠️ Rules & Regulations
 
The department will issue regulations to implement this section.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6809
 
Shared pharmacy services
 
 
🔹 1. Who Can Participate
 
•  Pharmacies must be properly registered under NY law.
•  They may engage in shared services only if they:
  ⁠◦  Have the same owner, or
  ⁠◦  Have a written contract outlining responsibilities.
•  They must share a common electronic file/technology that provides all information needed to perform shared services.
 
🔹 2. Operational Requirements
 
Pharmacies must:
 
Recordkeeping & Tracking
 
•  Keep detailed records for each prescription, identifying:
  ⁠◦  Every pharmacy involved
  ⁠◦  Every individual involved
  ⁠◦  License/registration numbers
•  Maintain a tracking system showing each step of processing/filling.
 
 
 
 
 
Regulatory Notifications
 
•  Notify NYSED within 30 days of any out‑of‑state disciplinary action related to shared services.
 
Labeling
 
•  Labels must list all pharmacies involved and their registration numbers.
•  Controlled substances follow additional Public Health Law Article 33 rules.
•  Hospitals are exempt from these labeling requirements.
 
 
Privacy & Controlled Substances
 
•  Maintain systems protecting confidentiality and integrity of patient information.
•  Follow all controlled‑substance storage, processing, and dispensing rules.
 
🔹 3. Patient Notification & Consent
 
Pharmacies must:
 
Notify Patients
 
•  Post conspicuous signage (or website notice for internet pharmacies) informing patients that prescriptions may be processed or filled off‑site.
 
 
Obtain Consent
 
•  Obtain one‑time written or electronic consent before dispensing any prescription using shared services.
•  Consent must be documented in the patient profile.
•  Patients may opt out at any time.
•  Hospitals are exempt.
 
🔹 4. Drug Storage & Security
 
•  Drugs must be securely stored and transported.
•  Access must be limited to authorized personnel.
•  Security systems must protect patient information.
 
🔹 5. Policies & Procedures
 
Participating pharmacies must jointly create and maintain policies that:
 
•  Define each pharmacy’s responsibilities
•  List all participating pharmacies and registration numbers
•  Include procedures for:
  ⁠◦  Patient notification
  ⁠◦  Protecting patient information
  ⁠◦  Handling prescriptions not yet received from a partner pharmacy
  ⁠◦  Tracking each step of processing
  ⁠◦  Ensuring compliance with all laws
•  Hospitals are exempt from certain notification and contingency‑fill requirements.
 
 
🔹 6. Remote Access by Licensed Personnel
 
Pharmacists and authorized staff may access the pharmacy’s database from inside or outside the pharmacy if:
 
•  Patient information is protected
•  No part of the database is downloaded, duplicated, or removed
 
🔹 7. Enforcement
 
Failure to comply may result in denial of registration renewal.
 
Effective: May 22, 2026
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6810
 
Prescriptions
 
📘 Summary of Prescription Drug Dispensing Requirements
 
🔹 1. Prescription‑Only Drugs
 
•  Any drug requiring a prescription under federal law or by the NYS Commissioner of Health may only be dispensed pursuant to a valid prescription issued by an authorized prescriber.
•  Dispensing and compounding must be performed only by a licensed pharmacist.
 
🔹 2. Mandatory Prescription Label Elements
 
Every prescription‑required drug must be labeled with:
 
•  Name and address of the dispensing establishment’s owner
•  Date compounded/dispensed
•  Prescription number
•  Prescriber’s name
•  Patient’s name and address
•  Directions for use
•  Labels must comply with commissioner regulations under §6829.
 
🔹 3. Controlled Substances
 
•  Prescribing and dispensing of controlled substances must follow additional requirements under Public Health Law Article 33.
 
🔹 4. Items Not Considered “Drugs” Under This Section
 
•  Soft or hard contact lenses
•  Eyeglasses
•  Any other vision‑correcting devices
 
🔹 5. Pharmacy‑to‑Pharmacy Transfers
 
•  A pharmacy may furnish a drug to another pharmacy lacking stock solely for the purpose of filling a prescription.
 
🔹 6. Special Labeling Rule for Mifepristone/Misoprostol
 
•  At the prescriber’s request, the label may list the name or address of the prescriber’s health care practice instead of the individual prescriber.
 
🔁 7. Refill Requirements
 
•  A prescription cannot be refilled unless it explicitly authorizes refills and states the number allowed.
•  Refills may not exceed the number authorized.
•  Each refill must be dated on the original prescription.
•  Controlled substance refills must follow Article 33.
 
 
 
🚚 8. Delivery of Prescriptions
 
•  Pharmacies registered under §6808 or §6808‑b may not deliver new or refilled prescriptions off‑premises without patient (or authorized individual) consent.
•  Consent may follow the same standards used in Medicare Part D.
 
If medication is delivered without consent:
 
•  Pharmacy must accept the return
•  Provide credit for any charges
•  Destroy the medication in accordance with state and federal law
 
Exemptions:
 
•  Refill reminder and adherence programs
•  Long‑term care pharmacy dispensing and delivery
 
📄 9. Copies of Prescriptions
 
•  Controlled substances: Copies may be furnished only to another authorized prescriber, not to the patient.
•  Non‑controlled prescriptions: Copies must be provided to the patient upon request, but must be clearly marked as “for informational purposes only” and intended for prescribers.
 
📝 Oral Prescriptions & Refills
 
•  Controlled substances: Oral prescriptions must follow Article 33 of the Public Health Law.
•  Non‑controlled drugs: A pharmacist may fill an oral prescription or oral refill authorization from a legally authorized prescriber.
•  For oral refill authorizations, the pharmacist must write the date, time, and prescriber’s name on the back of the original prescription.
•  Oral prescriptions or refills may be communicated by a prescriber’s employee if the pharmacist:
  ⁠◦  Reduces the prescription to writing,
  ⁠◦  Labels as required for written prescriptions,
  ⁠◦  Makes a good‑faith effort to verify the employee’s identity.
 
🏥 Institutional Settings
 
•  In hospitals, nursing homes, residential health care facilities, mental hygiene facilities, or OPWDD facilities, oral orders may be communicated to a contracted vendor pharmacy by a licensed health care practitioner designated by the prescriber or institution.
 
📚 Recordkeeping Requirements
 
•  Pharmacies must keep all prescription and refill records for at least 5 years.
•  Records must show: date filled/refilled, prescriber’s name, patient’s name and address, and the pharmacist’s name/initials.
•  Controlled substance records must follow Article 33 requirements.
 
✍️ Prescription Form Requirements
 
•  Every written prescription must:
  ⁠◦  Have one signature line; the prescriber’s signature validates the prescription.
  ⁠◦  Include the mandatory statement:
“THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES ‘d a w’ IN THE BOX BELOW” (8‑point uppercase).
  ⁠◦  Include a DAW box directly under the signature line (¾” × ½”), with “Dispense As Written” printed below in 6‑point type.
  ⁠◦  DAW cannot be preprinted; only the prescriber’s handwritten “d a w” (or electronic DAW direction) prohibits substitution.
 
🔄 Generic & Biosimilar Substitution Rules
 
•  If a generic or interchangeable biological is not available, and the pharmacist agrees to dispense the brand at no higher price than the generic would have cost, substitution is not required.
•  In a medical emergency (severe pain, risk of disability, or life‑threatening condition), if the generic/biosimilar is unavailable, the pharmacist may dispense the brand at regular price and must record the date, hour, and nature of the emergency on the back of the prescription and keep a copy.
 
💬 Patient Notification
 
•  Prescribers must inform patients whether the prescription is for a brand, generic equivalent, or interchangeable biological product.
 
🏥 Hospital Exemption
 
•  These prescription‑form requirements do not apply to hospitals under Article 28 of the Public Health Law.
 
🚫 One‑Drug‑Per‑Form Rule
 
•  A prescription form may authorize only one drug.
•  Pharmacists may not dispense a drug from a form listing multiple drugs.
•  Exception: Pharmacists in hospitals, nursing homes, and similar facilities may dispense under contract, but must transcribe each order onto a patient‑specific prescription form.
📝 Prescription Format Requirements
 
•  Every written prescription must include BOTH:
  ⁠◦  The prescriber’s handwritten signature, and
  ⁠◦  A legible, conspicuous printed or stamped name of the signing prescriber.
•  The printed/stamped name:
  ⁠◦  Must appear in an appropriate location on the form.
  ⁠◦  Cannot appear on the signature line.
  ⁠◦  Cannot substitute for the actual signature.
 
🚫 Unlawful Distribution of Prescription Blanks
 
•  Only individuals licensed to issue prescriptions may receive prescription forms.
•  Knowingly distributing prescription blanks/forms to anyone not authorized is a Class B misdemeanor.
 
💻 Electronic Prescribing Mandate
 
After the statewide e‑prescribing standards took effect, all prescriptions must be issued electronically, except for the following situations:
 
Allowed Exceptions
 
1.  Veterinarians.
2.  Temporary technological or electrical failure (must follow regulatory criteria).
3.  Practitioners with an approved waiver (economic hardship, tech limitations, or exceptional circumstances).
4.  Impracticality exception:
  ⁠◦  When e‑prescribing would delay care and harm the patient.
  ⁠◦  For controlled substances: max 5‑day supply.
5.  Prescriptions to be dispensed by an out‑of‑state pharmacy.
 
📋 Documentation Requirements for Exceptions
 
•  Tech/electrical failure (10(b)) → Practitioner must document this in the patient’s health record.
•  Impracticality or out‑of‑state dispensing (10(d) or 10(e)) → Must document:
  ⁠◦  That e‑prescribing was impractical and would delay care OR
  ⁠◦  That the prescription was intended for an out‑of‑state pharmacy.
 
🔄 Waiver Rules
 
•  Waivers last up to one year.
•  Practitioner must notify DOH promptly once they gain e‑prescribing capability.
•  Waiver automatically terminates within a set period after capability is obtained.
 
🔁 Low‑Volume Prescriber Certification (Repealed June 1, 2026)
 
•  Practitioners could certify that they would issue no more than 25 prescriptions in 12 months.
•  Included all prescriptions (oral + written; controlled + non‑controlled).
•  Up to three consecutive 12‑month certifications allowed.
•  Could be used regardless of prior waiver status.
 
🏭 Outsourcing Facilities
 
•  An outsourcing facility may not dispense pursuant to a prescription unless it is also registered as a pharmacy in New York and meets all state and federal requirements.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6811
 
Misdemeanors
 
🚫 Summary of Prohibited Acts Under This Section
 
1. Licensing & Representation
 
•  Operating a pharmacy without properly posting the licenses of all pharmacists not employed there.
•  Using terms like “drugs,” “medicine,” “drug store,” “apothecary,” or “pharmacy” in a business name or advertising unless the business is a licensed pharmacy.
 
2. Improper Agreements & Secret Prescriptions
 
•  Entering agreements with prescribers to compound or dispense secret or coded prescriptions.
 
3. Adulterated or Misbranded Products
 
•  Manufacturing, selling, offering, holding, or receiving adulterated or misbranded drugs, devices, or cosmetics.
•  Altering or removing labeling in a way that results in misbranding.
 
4. False or Misleading Information
 
•  Disseminating false advertisements.
•  Using unauthorized or falsified marks, labels, stamps, or identification devices.
•  Suggesting on labeling or advertising that a drug has an approved application under §6817 when it does not.
 
5. Interference With Oversight
 
•  Refusing lawful entry, inspection, or access to required records.
 
6. Trade Secrets
 
•  Misusing or disclosing trade‑secret information obtained under this article, except to authorized officials or courts.
 
7. Specific Product Restrictions
 
•  Retail sale or giveaway of bichloride of mercury tablets unless compliant with National Formulary XII, with limited exceptions for compounded or bulk forms.
 
8. Pharmacy Pricing Transparency
 
•  Failing to post the required price list under §6826.
•  Changing selling prices without updating the posted list.
 
9. Record Access
 
•  Refusing access to or copying of records required under this article.
 
10. Manufacturing Standards
 
•  Manufacturers selling drugs not prepared under the personal supervision of a chemist or licensed pharmacist, or not labeled with the manufacturer’s full name.
 
11. Outsourcing Facilities
 
•  Outsourcing facilities selling drugs not compounded under a licensed pharmacist’s supervision or not labeled with the facility’s full name.
 
 
 
This summary page was last updated April 5, 2026

 
Education Law §6811-a
 
Certain drugs to be clearly marked or labeled
 
📘 Summary: NY Requirements for Marking & Labeling Prescription Drug Products
 
🔹 1. Mandatory Imprints on Tablets & Capsules
 
Unless exempt under federal law, any prescription‑only tablet or capsule manufactured or commercially distributed in New York must have clear, compliant imprinting that includes:
 
•  A unique symbol, number, letters, words, company name, or NDC identifying the manufacturer or distributor.
•  An NDC, symbol, number, letters, or words identifying the specific drug or drug combination.
 
🔹 2. Mandatory Markings on Containers & Packaging
 
Prescription‑only drugs packaged for delivery to the consumer (bottles, vials, cartons, etc.) must be clearly and permanently marked with:
 
•  A symbol, NDC, number, letters, words, or company name identifying the manufacturer or distributor.
•  A symbol, NDC, number, letters, or words identifying the drug.
•  If the distributor is not the manufacturer, the names and business locations of both must appear, clearly distinguishing each role.
 
🔹 3. Required Compliance Plans
 
Manufacturers and distributors must submit a written compliance plan to the Commissioner of Health that:
 
•  Lists dates when each product will meet imprinting/labeling requirements.
•  Explains the rationale for proposed timelines.
•  Includes any additional information required by the Commissioner.
The Commissioner may approve, amend, or replace the plan; it becomes effective only upon approval.
 
🔹 4. Imprint Identification Materials
 
Manufacturers and distributors must provide printed identification materials for all imprints they use to:
 
•  The Department of Education
•  Physicians, dentists, pharmacies, hospitals, and other institutions
Updated materials must be supplied upon changes and annually upon request.
Compliance is satisfied if the product appears in the Physician’s Desk Reference.
 
🔹 5. Penalties & Enforcement
 
•  Violations are punishable by a $2,500–$10,000 fine per prescription drug product.
•  Non‑compliant products are contraband and may be seized by the State Board of Pharmacy or law enforcement.
 
🔹 6. Exemptions
 
The imprinting/labeling requirements do not apply to:
 
•  Tablets or capsules containing controlled substances under Article 33 of the Public Health Law.
•  Products compounded by a licensed pharmacist for retail sale only from their principal place of business (not for resale).
•  Products granted an exemption by the Commissioner of Health when imprinting is unfeasible due to size, texture, or unique characteristics.
 
🔹 7. Definitions
 
•  Distributor: An entity that is not the manufacturer but distributes a prescription drug product for resale under its own label.
•  Drug product (for compliance plan purposes): The entire supply of the finished dosage form.
 
This summary page was last updated April 5, 2026

 
Education Law §6811-b
 
Door-to-door distribution of drugs prohibited
 
🚫 General Prohibition
 
•  No free drug samples (except non‑ingestible cosmetics) may be distributed to a residential dwelling unless:
  ⁠◦  The sample is handed directly to a person who is or appears to be 18 or older.
 
💵 Penalty
 
•  Violation = fine up to $250.
 
⚖️ Important Clarification
 
•  This rule does not authorize sample distribution in situations where it is otherwise prohibited under any other state or federal law.
 
🔍 Key Points for Advocacy or Compliance Materials
 
•  Direct hand‑to‑adult transfer is mandatory — leaving samples at doors, mailboxes, lobbies, or common areas is prohibited.
•  Age verification is based on reasonable appearance, not formal ID.
•  Cosmetic samples not intended for ingestion are exempt.
•  Other laws still control — this section doesn’t override stricter prohibitions (e.g., controlled substances, unsafe distribution practices).
•  Penalty is civil, not criminal, but still enforceable and relevant for compliance messaging.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6811-c
 
Patient notification of recalled drugs
 
📘 Summary of Requirements for Class I Drug Recalls
 
🔍 What “Class I Recall” Means
 
•  A Class I recall is defined as a situation where the FDA determines there is a reasonable probability that using or being exposed to the recalled product will cause serious adverse health consequences or death.
 
📞 Pharmacy Notification Duties
 
When a Class I recall involves a prescription drug, pharmacies must:
 
•  Make a reasonable attempt to notify all patients who:
  ⁠◦  Were prescribed the recalled drug, and
  ⁠◦  Are currently taking the recalled drug dispensed by that pharmacy.
•  Notification must be made by phone or by mail.
•  Notification must occur within three days of the pharmacy receiving recall notice from:
  ⁠◦  The FDA,
  ⁠◦  A manufacturer,
  ⁠◦  A wholesaler, or
  ⁠◦  Any other recall notice source.
🏬 Chain Pharmacies
 
•  The required notification may be performed by an individual pharmacy, or
•  It may be handled by a central office if the pharmacy is part of a chain.
 
 
This summary page was last updated April 5, 2026
 
 

 
Education Law §6811-d
 
Notification of permanent pharmacy discontinuance
 
📘 Summary of Permanent Pharmacy Discontinuance Requirements (NY Educ. Law §6811‑D)
 
🕒 30‑Day Advance Public Notice
 
Every registered retail pharmacy must provide public notice at least 30 days before permanently closing.
 
📣 How Notice Must Be Delivered
 
•  Direct notification to customers
  ⁠◦  To the extent possible, the pharmacy must notify all customers who filled a prescription within the past year.
  ⁠◦  Notification must use the customer’s primary communication method on file (e.g., phone, email, mail).
  ⁠◦  This ensures patients relying on the pharmacy are not caught off guard.
 
•  Conspicuous in‑store posting
  ⁠◦  Notice must be clearly posted where prescriptions are dropped off,
  ⁠◦  In the waiting area, or
  ⁠◦  Where medications are dispensed.
  ⁠◦  The goal is to ensure every walk‑in patient sees the closure information.
 
📄 Required Contents of the Notice
 
The closure notice must include all of the following:  A
 
1. Closure Date
 
•  The exact date the pharmacy will permanently discontinue operations.
 
2. Five Nearest Pharmacies
 
•  Names, addresses, and phone numbers of the five closest pharmacies,
•  Including independent pharmacies, when applicable.
•  This ensures patients have immediate alternatives for continuity of care.
 
3. Prescription Transfer Instructions
 
•  Clear steps for how patients can transfer existing prescriptions to another pharmacy of their choice.
•  This is critical for uninterrupted therapy, especially for chronic medications.
 
4. Disposition of Prescription Records
 
•  Information explaining what happens to prescription records if a patient does not transfer before closure.
•  This typically includes where records will be maintained and how patients can later access them.
 
🧭 Why This Matters
 
These requirements are designed to:
 
•  Protect patient access to medications,
•  Prevent therapy interruptions,
•  Ensure transparency,
•  Maintain continuity of care, and
•  Provide clear pathways for patients to retrieve or transfer their records.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6812
 
Special provisions
 
🔥 Fire Damage & Pharmacy Closures
 
•  If a pharmacy, manufacturer, wholesaler, or outsourcing facility registered with the department is damaged by fire, the Board of Pharmacy must be notified within 48 hours.
•  The Board may impound all drugs for analysis and condemnation if they are found unfit for use.
 
🗂 Prescription Records on Discontinuance
 
•  When a pharmacy permanently closes, the owner must notify the department about how its prescription records will be handled.
•  Records may only be transferred to someone who already holds a valid pharmacy registration — they cannot be sold or given to an unregistered person.
 
⚖️ Enforcement Discretion
 
•  Minor violations do not require prosecution if the public interest is adequately protected by issuing a written warning.
 
🔍 Investigative Authority
 
•  The executive secretary of the State Board of Pharmacy may conduct examinations and investigations using:
  ⁠◦  Federal officers or employees
  ⁠◦  State or local health, food, or drug officials
 
 
This summary page was last updated April 5, 2026

 
Education Law §6813
 
Seizure
 
🚫 Seizure & Condemnation of Illegal or Unsafe Products — Summary
 
🔍 When Products Can Be Seized
 
A drug, device, or cosmetic may be seized and condemned if it is:
 
•  Adulterated
•  Misbranded
•  Prohibited from sale under this chapter
 
Seizure can occur:
 
•  By court process following a petition or complaint from the board, or
•  Without prior court process if the secretary (or designee) has probable cause to believe the product:
  ⁠◦  Cannot legally be sold
  ⁠◦  Is adulterated
  ⁠◦  Is dangerously misbranded
 
🏷️ How Seizure Works
 
•  The officer issues an order describing:
  ⁠◦  The article
  ⁠◦  Its location
  ⁠◦  The officer conducting the seizure
•  Instead of removing the product, the officer may quarantine it with a tag or marking prohibiting removal or sale.
•  Once seized or quarantined, court jurisdiction attaches, and a condemnation petition must be filed promptly.
 
⚖️ Court Procedure
 
•  Follows procedures similar to attachment actions.
•  Either party may demand a jury trial on factual issues.
•  Before trial, the court must allow parties to obtain:
  ⁠◦  A representative sample
  ⁠◦  A copy of the analysis used
  ⁠◦  Identifying marks from the analyzed packages
 
🧪 Disposition of Condemned Products
 
•  After condemnation, the court may order destruction or sale.
•  Sale proceeds go to the state treasury after costs.
•  Products cannot be sold in violation of the article.
•  The owner may reclaim the product after paying costs and posting a bond, but only to:
  ⁠◦  Destroy it, or
  ⁠◦  Bring it into compliance under supervision (owner pays supervision costs)
•  New drugs condemned for being unlawfully marketed must be destroyed, not sold.
 
💰 Costs & Liability
 
•  When condemnation is ordered, court costs, fees, and storage expenses are charged to the claimant.
•  The board, secretary, or their agents are not liable for seizure or quarantine if the court finds probable cause existed.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6814
 
Records of shipment
 
📘 Summary: Access to Shipping & Commerce Records
 
•  Carriers and anyone receiving or holding drugs, devices, or cosmetics in commerce must allow authorized officers to access and copy records showing:
  ⁠◦  How these items moved in commerce
  ⁠◦  Where they were held
  ⁠◦  Quantities shipped
  ⁠◦  Shippers and consignees
•  Access must be provided at reasonable times and only when the officer provides a written statement identifying the specific type of product involved.
•  Refusing access is unlawful.
•  Protection for record‑holders:
Information obtained under this section cannot be used in a criminal prosecution against the person who provided it.
•  Protection for carriers:
Carriers are not subject to other regulatory provisions of the article solely because they transport or handle these products in the normal course of business.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6815
 
Adulterating, misbranding  and substituting
 
🔍 Summary: Adulterated & Misbranded Drugs/Devices
 
🧪 When a Drug or Device Is Considered Adulterated
 
A product is adulterated if any of the following apply:
 
1. Contamination or Unsafe Conditions
 
•  Contains filthy, putrid, or decomposed material.
•  Prepared, packed, or stored under insanitary conditions that may cause contamination or harm.
•  Container is made of poisonous or harmful materials.
•  Contains uncertified coal‑tar colors used solely for coloring.
 
2. Failure to Meet Official Standards
 
•  Purports to be an official compendium drug but differs in strength, quality, or purity from compendial standards.
•  Testing must follow compendial methods (or board‑approved methods if absent).
•  Not adulterated if differences in strength/purity are clearly stated on the label, but only for drugs the board designates as eligible.
 
3. Non‑Compendial Products
 
•  If not covered by compendial rules, it still cannot differ from what it claims in strength, purity, or quality.
 
4. Dilution or Substitution
 
•  Mixed, packed, or substituted with other substances that reduce quality or strength.
 
5. Non‑USP/NF Formulas
 
•  If sold under a name/formula from another recognized pharmacology reference, it must meet that reference’s standards.
 
🏷️ When a Drug or Device Is Considered Misbranded
 
A product is misbranded if any of the following apply:
 
1. False or Misleading Labeling
 
•  Any part of the labeling is false or misleading.
•  Required information is not prominently displayed.
 
2. Missing Basic Label Information
 
•  Package lacks:
  ⁠◦  Manufacturer/packer/distributor name and address.
  ⁠◦  Accurate quantity statement (weight, measure, count).
 
3. Habit‑Forming Substances
 
•  Contains certain narcotic/hypnotic substances but lacks the statement:
“Warning—May be habit forming.”
 
4. Ingredient Disclosure
 
•  If not sold under an official compendium name, label must list:
  ⁠◦  Common/usual name.
  ⁠◦  All active ingredients.
  ⁠◦  Specific disclosure of alcohol %, and certain potent substances (e.g., digitalis, mercury, atropine).
 
5. Directions & Warnings
 
•  Must include:
  ⁠◦  Adequate directions for use.
  ⁠◦  Adequate warnings for unsafe conditions, populations, or dosing.
 
6. Compendial Packaging/Labeling
 
•  If recognized in an official compendium, must follow compendial packaging/labeling rules (USP unless labeled as homeopathic).
 
7. Deceptive Packaging or Identity
 
•  Container is misleading.
•  Imitation of another drug.
•  Sold under another drug’s name.
•  Bears counterfeit or imitation trademarks, labels, or designs.
 
8. Unsafe as Labeled
 
•  Dangerous to health when used as directed or suggested.
 
📦 Special Rule for Dispensed Prescriptions
 
Compounding/dispensing on a prescriber’s written prescription is exempt from most labeling rules, but the dispensed label must include:
 
•  Dispenser name & address
•  Prescription number & date
•  Directions for use
•  Patient name & address
•  Prescriber name
•  Drug brand/proprietary name and strength (unless prescriber handwrites “do not label name/strength”)
 
 
This summary page was last updated April 5, 2026

 
Education Law §6816
 
Omitting to label drugs, or labeling them wrongly
 
🔍 Summary of Key Provisions
 
⚖️ Core Offense
 
A person commits a misdemeanor if, when preparing or dispensing any drug, medicine, food, or medical preparation, they:
 
•  Apply a false or misleading label to the product.
•  Substitute a different product for the one prescribed, ordered, or requested (unless substitution is required under §6816‑a).
•  Use a greater or lesser quantity of any ingredient than prescribed (unless required under Social Services Law §365‑a(2)(g)).
•  Otherwise deviate from the prescriber’s instructions, including unauthorized drug substitution.
 
NY Social Services Law §365-a(2)(g) defines, as part of "standard coverage" for Medicaid, inpatient or outpatient care, services, and supplies for sterilization, family planning, and reproductive health services. This section ensures coverage for necessary reproductive care for eligible individuals.
 
 
 
 
🛑 Important Exception
 
This restriction does not prohibit a pharmacist or seller from recommending or selling a similar alternative product as long as the purchaser knows and consents—but never for physician prescriptions.
 
🚨 Penalties
 
First conviction
 
•  Classified as a misdemeanor.
 
Second conviction
 
•  Mandatory fine up to $1,000.
•  Possible imprisonment up to 1 year.
 
Third conviction
 
•  All penalties of a second conviction plus:
  ⁠◦  Permanent forfeiture of the right to work as a pharmacist, druggist, apothecary, or in any role involving compounding or dispensing drugs or medical preparations.
  ⁠◦  Permanent disqualification from engaging in such business in any capacity.
 
 
 
 
🧑‍⚕️ Practitioner Exemptions
 
This section does not apply to:
 
•  Practitioners who do not operate or work for a retail drug‑dispensing business.
•  Practitioners supplying medications directly to their own patients.
•  Wholesale transactions (except for poison‑labeling rules), which remain subject to Board of Pharmacy or health department regulations.
 
🏥 Limited Pharmacy Exception
 
A limited pharmacy (e.g., hospital pharmacy) is exempt if:
 
•  It maintains a formulary listing brand and generic names of drugs it stocks.
•  Each staff physician receives the formulary and signs authorization allowing the hospital to dispense drugs under any listed generic or non‑proprietary name.
•  All dispensing complies with Commissioner of Education regulations.
 
 
 
 
 
 
 
📘 Definition Clarification
 
For this section:
 
•  “Prescription, order, or demand” applies only to items covered under §6810(1) (i.e., items requiring a prescription).
•  A physician’s written order for items not covered under §6810(1) is treated as a direction, fiscal order, or voucher, not a prescription.
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6816-a
 
When substitution is required
 
🔄 Drug & Biological Product Substitution — Summary
 
💊 Generic Drug Substitution (Required When Allowed)
 
A pharmacist must substitute a less expensive, equivalent drug (same active ingredients, dosage form, and strength) if all conditions are met:
 
✔️ Conditions for Substitution
 
•  Prescription form requirements met, and
  ⁠◦  Prescriber does NOT prohibit substitution;
  ⁠◦  For oral prescriptions, the prescriber must explicitly state “substitution permitted” or “substitution prohibited.”
  ⁠◦  If no explicit statement is given, the oral prescription may NOT be filled.
•  The generic product is on the NYS drug product interchange list (Public Health Law §206(1)(o)).
•  The pharmacist must:
  ⁠◦  Label the container with the drug name, strength, and manufacturer unless the prescriber directs otherwise.
  ⁠◦  Record the brand name or manufacturer of the product dispensed on the prescription.
 
🌐 Out‑of‑State Filling
 
If a patient fills the prescription in another state, that state’s laws control.
 
🧬 Biological Product Substitution
 
A pharmacist may substitute a less expensive biological product only if all of the following are true:
 
✔️ Conditions for Biosimilar/Interchangeable Substitution
 
•  The substituted product is:
  ⁠◦  An FDA‑designated interchangeable for the prescribed product, or
  ⁠◦  The prescribed product is interchangeable with the substituted product.
•  The prescriber has not prohibited substitution.
•  The pharmacist labels the container with the product name, strength, and manufacturer, unless the prescriber states otherwise.
 
📣 Prescriber Notification Requirement
 
Within 5 business days of dispensing a substituted biological product, the pharmacist (or designee) must notify the prescriber of:
 
•  The exact product dispensed, including name and manufacturer.
 
Acceptable communication methods:
 
•  Entry into an interoperable electronic medical record, e‑prescribing system, or pharmacy record accessible to the prescriber, or
•  Fax, electronic transmission, or other electronic means.
•  If electronic methods are unavailable, telephone communication is permitted.
 
❗ When Notification Is Not Required
 
•  No FDA‑approved interchangeable exists for the prescribed product.
•  The refill uses the same product previously dispensed.
 
🗂️ State Resource
 
The Department of Health must maintain a public link to the current FDA list of interchangeable biological products.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6817
 
New drugs
 
🧾 Core Rule: No New Drug Sales Without Prior Authorization
 
A new drug cannot be sold, delivered, offered, or given away unless it is either:
 
•  Approved under the Federal Food, Drug, and Cosmetic Act (FDCA); or
•  If not subject to the FDCA, it has been tested and shown not unsafe or ineffective, and the manufacturer has filed a full application with the state health department.
 
🧪 When a Drug Is Not Under FDCA Jurisdiction
 
Before marketing, the manufacturer must file an application including:
 
•  Full safety and efficacy investigation reports
•  Complete ingredient list
•  Full composition statement
•  Manufacturing methods, facilities, and controls
•  Samples of the drug and its components
•  Proposed labeling specimens
 
The application becomes effective after 180 days, unless the board/secretary—after notice and hearing—denies it for safety or efficacy concerns.
💊 Prescription Drug Exemption
 
A drug dispensed on a valid written or oral prescription (excluding controlled substances) is exempt if the label includes:
 
•  Dispenser name and address
•  Prescription serial number and date
•  Directions for use
•  Prescriber’s name
•  Patient name
•  Brand/proprietary name and strength, unless the prescriber handwrites an instruction to omit them.
 
🔬 Investigational Drug Exemptions
 
The board may exempt investigational drugs (including controlled substances with DOH concurrence) labeled “For Investigational Use Only.” Conditions may include:
 
1. Preclinical Data Submission
 
Manufacturers/sponsors must submit animal and other preclinical test results before any human clinical testing.
 
2. Investigator Agreements
 
Sponsors must obtain signed agreements ensuring:
 
•  Patients are under the personal supervision of qualified investigators
•  Investigators do not redistribute the drug to others
 
3. Recordkeeping & Reporting
 
Sponsors must maintain records and submit reports (including analytical data) enabling the board to evaluate safety and effectiveness for any future new‑drug application.
 
🧬 Biologics Exemption
 
This section does not apply to drugs licensed under:
 
•  The Virus, Serum, and Toxin Act of 1902
•  Public Health Service Act §262 (1944)
•  The Virus, Serums, Toxins, Antitoxins and Analogous Products Act of 1913
 
These products follow separate federal biologics licensing pathways.
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6818
 
Adulterated and misbranded cosmetics
 
🧪 Adulterated Cosmetics — When a Product Is Legally “Unsafe”
 
A cosmetic is deemed adulterated if any of the following apply:
 
1. Harmful or Poisonous Ingredients
 
•  Contains a poisonous or harmful substance that could injure users under normal or labeled use.
•  Exception: Coal‑tar hair dyes are exempt if they carry the required warning label and directions for a skin‑sensitivity test.
 
2. Filth or Decomposition
 
•  Contains any filthy, putrid, or decomposed material.
 
3. Insanitary Conditions
 
•  Prepared, packed, shipped, or stored under conditions that could make it harmful.
 
4. Toxic Containers
 
•  The container itself contains poisonous materials that could contaminate the product.
 
5. Unauthorized Coal‑Tar Colors
 
•  If not a hair dye, it contains a coal‑tar color that is not from a certified batch.
 
🏷️ Misbranded Cosmetics — When Labeling or Packaging Is Deceptive
 
A cosmetic is considered misbranded if any of the following occur:
 
1. False or Misleading Labeling
 
•  Any part of the labeling is untrue or misleading.
 
2. Missing Required Label Information
 
For packaged products, the label must include:
 
•  Name and address of manufacturer, packer, or distributor.
•  Accurate quantity statement (weight, measure, or count).
  ⁠◦  Reasonable variations and small‑package exemptions are allowed.
 
3. Poor Label Placement
 
•  Required information is not displayed prominently or clearly enough for an ordinary consumer to read under normal conditions.
 
4. Deceptive Containers
 
•  The container is shaped, filled, or designed in a way that misleads the consumer.
 
5. Counterfeit or Imitation Branding
 
•  Bears a copy, counterfeit, or imitation of another cosmetic’s trademark, label, or identifying design.
 
This summary page was last updated April 5, 2026
 

 
Education Law §6818-a
 
Cosmetic samples
 
🧴 Summary of Cosmetic Sample Restrictions
 
🚫 General Prohibition
 
A business cannot allow customers to use or apply cosmetic testers if the same immediate container will be used by more than one person—unless the sample is applied only to the hand or arm. 
 
✅ Allowed Exceptions
 
The law does NOT consider the following to be prohibited “cosmetic” uses:
 
•  Perfume or cologne
•  Samples taken with a single‑use disposable applicator (one per customer)
•  Samples dispensed from hygienic containers such as:
  ⁠◦  Tubes
  ⁠◦  Pumps
  ⁠◦  Sprays
  ⁠◦  Shaker containers
•  Samples or applicators that are cleaned before each use
 
These exceptions allow safe, hygienic sampling without violating the rule.
 
📌 Compliance Through Posted Instructions
 
A business satisfies the law if it clearly posts written instructions explaining how cosmetic samples must be used under these hygiene rules.
These instructions must be visible at or near the sample display.
 
💄 Trained Personnel Exception
 
The law does not prohibit cosmetic application by trained staff, as long as they follow the same hygiene requirements (e.g., single‑use applicators, cleaned tools, or hygienic dispensers).
 
⚖️ Penalties
 
Violations result in:
·      First Offense $100
·      Second or subsequent offense $250
 
 
This summary page was last updated April 5, 2026

 
Education Law §6819
 
Regulations making exceptions
 
🏷️ Summary: Labeling Exemption for Bulk‑Processed Products
 
The board must create regulations that waive labeling requirements for drugs, devices, and cosmetics that are routinely processed, labeled, or repacked in large quantities at facilities other than where they were originally made.
 
This exemption only applies if, after leaving the processing or repacking facility, the products are not adulterated or misbranded under the law.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6820
 
Certification of coal-tar colors for drugs and cosmetics
 
🎨 Summary: Coal‑Tar Color Listings & Certification
 
The board must issue regulations that:
 
•  Identify which coal‑tar colors are harmless and appropriate for use in drugs (for coloring only) and in cosmetics.
•  Establish a system to certify each batch of these approved colors, including batches mixed with harmless diluents.
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6821
 
Poison schedules: register
 
☠️ Poison Schedules & Retail Requirements — Summary
 
📌 Schedules of Poisons
 
These schedules remain in effect until formally revised.
 
🔴 Schedule A (Highly Dangerous Poisons)
 
Includes:
 
•  Arsenic
•  Atropine
•  Corrosive sublimate
•  Potassium cyanide
•  Chloral hydrate
•  Hydrocyanic acid
•  Strychnine
•  All poisonous vegetable alkaloids and their salts
•  Oil of bitter almond containing hydrocyanic acid
 
🟠 Schedule B (Other Dangerous Poisons)
 
Includes:
 
•  Aconite, belladonna, cantharides, colchicum, conium, cotton root
•  Digitalis, ergot, hellebore, henbane, phytolacca, strophanthus
•  Oils of savin and tansy, veratrum viride
•  Their pharmaceutical preparations
•  Arsenical solutions, carbolic acid, chloroform, creosote, croton oil
•  White precipitate, methyl/wood alcohol, mineral acids, oxalic acid
•  Paris green, salts of lead and zinc
•  Any drug or chemical lethal to an adult in ≤ 60 grains
 
🏷️ Labeling Requirements
 
For Retail Sellers (Schedules A & B)
 
Must affix a label that includes:
 
•  Name of the substance
•  The word “POISON” clearly shown
•  Seller’s name and business address
•  All printed in red ink
•  Poison name must be plainly legible
 
For Manufacturers & Wholesalers (Schedule A)
 
Must label every original package with:
 
•  A suitable red‑ink label or brand
•  The word “POISON”
 
📚 Record‑Keeping Requirements (Schedule A Retail Sales)
 
Before dispensing, the seller must record:
 
•  Date of sale
•  Purchaser’s name and address
•  Name and quantity of poison
•  Intended purpose
•  Name of the dispenser
 
Additional rules:
 
•  The poison register must be open to authorities
•  Records must be kept at least 5 years
•  Seller must ensure the purchaser understands the poison’s nature and has a legitimate purpose
•  Does not apply to dispensing pursuant to a physician’s prescription
 
⚖️ Board Authority
 
•  The board may add or remove substances from the schedules as needed to protect public health.
 
 
 
This summary page was last updated April 5, 2026

 
Education Law §6822
 
Examinations and investigations
 
🔹 Summary
 
The secretary may carry out examinations and investigations under this article by using federal officers or any local health, food, or drug officials who have been formally commissioned as board officers.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6823
 
Factory inspection
 
🔍 Summary: Inspection & Entry Powers
 
•  Authorized officers may enter, at reasonable times, any:
  ⁠◦  Factory, warehouse, or establishment where drugs, devices, or cosmetics are made, processed, packed, or stored for introduction into commerce
  ⁠◦  Locations where such products are held after entering commerce
  ⁠◦  Vehicles transporting or holding these products in commerce
•  They may inspect, at reasonable times:
  ⁠◦  The facility or vehicle
  ⁠◦  All relevant equipment
  ⁠◦  Finished and unfinished materials
  ⁠◦  Containers and labeling associated with the products
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6824
 
Injunction proceedings
 
🔍 Summary: Injunction Authority of the Secretary
 
The secretary may go directly to court to obtain an injunction—without needing to prove that other legal remedies are inadequate—to stop any person from:
 
•  Introducing adulterated or misbranded drugs, devices, or cosmetics into commerce
•  Introducing a new drug that does not meet legal requirements
•  Disseminating false advertising
 
This injunction power is an additional enforcement tool beyond other remedies provided in the article.
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6825
 
Proof required in prosecution for certain violations
 
⚖️ Summary: Procedures, Defenses, and Liability in Misbranding/Substitution Cases
 
🧪 Required Sampling Procedure for Prosecution
 
•  In any civil or criminal case involving misbranded, substituted, or imitated drugs, poisons, or cosmetics, the state must prove that:
  ⁠◦  The sample was split into two representative, sealed portions.
  ⁠◦  One sealed portion was given to the seller/manufacturer/pharmacist from whom it was taken.
  ⁠◦  The other sealed portion was sent to the chemist designated by the State Board of Pharmacy.
•  These procedural facts must be explicitly stated in the complaint.
•  Board rules may be proven prima facie by the secretary’s certificate.
 
🛡️ Guaranty Defense
 
A person accused of adulteration, misbranding, substitution, or imitation is not liable if they prove:
 
•  The product was purchased under a written guaranty stating it was not adulterated, misbranded, substituted, or imitated.
•  The guaranty includes:
  ⁠◦  Full name and business address of the manufacturer/wholesaler/jobber/seller.
  ⁠◦  The date of purchase.
•  The accused did not alter or misbrand the product and took due precautions to maintain its standard.
 
👥 Liability of Employers, Officers, and Organizations
 
•  Acts or omissions of an employee or agent are legally considered the acts of the employer or entity.
•  Partnerships, associations, and corporations are liable for violations.
•  Individual liability also attaches to:
  ⁠◦  Each partner or association member.
  ⁠◦  Corporate directors and general officers.
  ⁠◦  The general manager.
•  Prosecution may be brought against any or all of these individuals.
 
💰 Disposition of Fines
 
•  When a prosecution is initiated by the Board, collected fines are paid into the state treasury.
 
📢 Advertising Exception
 
•  Publishers, broadcasters, advertising agencies, and other media outlets are not liable for disseminating false advertisements unless they refuse to provide, upon request, the name and address of the party who caused the advertisement to be disseminated.
•  Manufacturers, packers, distributors, and sellers do not receive this exemption.
 
 
 
This summary page was last updated April 5, 2026

 
Education Law §6826
 
Drug retail price lists
 
🏷️ Drug Retail Price List Requirements — Summary
 
📌 Pharmacy Responsibilities
 
•  Maintain a drug retail price list containing:
  ⁠◦  All drugs on the Board’s official list.
  ⁠◦  The pharmacy’s actual retail price for each drug at the listed dosage.
•  Update the list at least weekly, including the date and time of the update.
•  Provide the list to any person upon request.
•  Post a conspicuous sign informing customers:
  ⁠◦  That the drug retail price list is available.
  ⁠◦  That the Department of Health (DOH) prescription drug price database is available, including its web address.
 
📌 Board of Pharmacy Responsibilities
 
•  Prepare and distribute—at least annually—a list of the 150 most frequently prescribed drugs requiring a prescription under federal or state law.
•  Provide this list to pharmacies free of charge, in:
  ⁠◦  Printed form
  ⁠◦  Electronic form suitable for generating the pharmacy’s price list
•  Provide the list to the Department of Health.
 
📌 Required Consumer Advisory
 
The pharmacy’s price list must include a DOH advisory urging consumers to:
 
•  Inform their healthcare providers and pharmacists about all medications they take.
•  Ask how to avoid harmful drug interactions.
 
📌 Optional Pharmacy Disclosures
 
Pharmacies may add statements about:
 
•  Available discounts.
•  Limitations on which customer groups they serve.
 
📌 Definition of Retail Price
 
•  Before the DOH database is implemented:
→ The actual price a retail customer would pay.
•  After implementation:
→ The price supplied by the DOH under Public Health Law §276‑a.
 
New York Public Health Law §276-a mandates that the Department of Health maintain a public, online database of retail prescription drug price lists from pharmacies. This database, accessible via the NYS Department of Health website, allows consumers to search, display, and compare prices for the 150 most frequently prescribed drugs, including the ability to download or print this information.
 
 
 
📌 Price Flexibility
 
•  Pharmacies may change their retail prices at any time, as long as the posted list is updated weekly.
 
📌 Regulatory Authority
 
•  The Commissioner must issue regulations to implement this section, including rules for mail‑order and internet pharmacies.
 
 
 
This summary page was last updated April 5, 2026

 
Education Law §6826-a
 
Reducing certain copayments
 
🧾 Summary of Copay‑vs‑Price Disclosure Requirement
 
•  If a patient’s copay is higher than the pharmacy’s listed retail price for that drug, the pharmacist must:
  ⁠◦  Inform the patient, and
  ⁠◦  Charge no more than the pharmacy’s retail price.
•  If the drug is not on the pharmacy’s retail price list, and the patient’s copay is higher than the pharmacy’s usual and customary (U&C) price, the pharmacist must:
  ⁠◦  Inform the patient, and
  ⁠◦  Charge the lower of:
      •  the patient’s copay, or
    •  the pharmacy’s U&C price.
 
This summary page was last updated April 5, 2026
 

 
Education Law §6827
 
Mandatory continuing education
 
📘 NY Pharmacist Mandatory Continuing Education — Summary
 
🔹 General Requirement
 
•  All pharmacists who register triennially must meet mandatory CE requirements unless exempt under specific provisions.
•  A pharmacist may not practice unless CE is completed and a valid registration certificate is issued.
•  A pharmacist may practice with unmet CE only if granted a conditional registration.
 
🔹 Exemptions & Adjustments
 
•  Adjustments may be granted for:
  ⁠◦  Certified health issues
  ⁠◦  Extended active U.S. military duty
  ⁠◦  Other “good cause” acceptable to the department
•  Exemption: Pharmacists not engaged in practice may file a statement declaring inactive status.
  ⁠◦  If returning to practice during the triennium, they must notify the department and complete CE as required by regulation.
 
🔹 CE Hour Requirements
 
Effective until July 1, 2026
 
•  45 hours of acceptable formal CE per triennial period.
•  Max 22 hours may be self‑study.
•  Pharmacists in collaborative drug therapy management (CDTM) must complete 5 hours in areas related to their CDTM protocols.
•  Newly licensed pharmacists (first registration <3 years from effective date but ≥ Jan 1, 1998) complete CE prorated at 1.25 hours/month.
•  CE cannot be carried over to the next triennium.
 
Effective July 1, 2026
 
•  Same as above minus the CDTM‑specific 5‑hour requirement (removed in the post‑2026 version).
 
🔹 Conditional Registration
 
•  May be issued to pharmacists who have not met CE requirements but agree to:
  ⁠◦  Make up deficiencies
  ⁠◦  Complete any additional CE required by the department
•  Fee = triennial registration fee + conditional registration fee.
•  Valid for up to one year.
•  Practicing without proper registration after denial may result in disciplinary action.
 
🔹 Definition of Acceptable CE
 
•  Must be formal courses that contribute to pharmacy practice.
•  Must meet standards set by the commissioner.
•  Must be taken from department‑approved sponsors.
•  The department may require CE in specific subjects for public health reasons.
 
🔹 Documentation
 
•  Pharmacists must maintain adequate proof of CE completion.
•  Must provide documentation upon request.
•  Failure to provide documentation is misconduct subject to discipline.
 
🔹 Fees
 
•  Mandatory CE fee: $45, due at the start of each triennial registration period.
•  Paid in addition to the standard triennial registration fee.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6828
 
Certificates of administration
 
📝 Summary: Pharmacist Immunization Certificate Requirements
 
•  A pharmacist may not administer immunizations unless they hold a certificate of administration issued by the Department under the commissioner’s regulations.
•  The certificate requires a $100 fee, paid every three years.
•  A certificate can be suspended or revoked using the same process that applies to a pharmacist’s license.
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6829
 
Interpretation and translation requirements for prescription drugs and standardized medication labeling
 
📝 Summary: Language Access Requirements for Covered Pharmacies
 
🏪 Who Must Comply
 
•  Covered pharmacies = Any pharmacy in New York that is part of a chain of 8+ pharmacies under the same corporate entity (including subsidiaries, affiliates, successors, or those operating under a common name).
•  Mail‑order pharmacies will also be required to comply once regulations are issued.
 
🌐 Key Definitions
 
•  LEP individual: Someone who cannot speak, read, or write English well enough to understand health or pharmacy information.
•  Translation: Written translation of pharmacy/health information by someone competent in the language and terminology.
•  Competent oral interpretation: Accurate verbal interpretation using appropriate pharmacy and health terminology.
•  Pharmacy primary languages: Languages spoken by ≥1% of the region’s population, up to 7 languages per region.
•  Mail‑order pharmacy: A pharmacy that dispenses most prescriptions via USPS or other delivery services.
 
🎧 Required Services (Free to the Patient)
 
1. Counseling & Profile Information
 
Covered pharmacies must provide free, competent oral interpretation and translation:
 
•  When counseling an LEP patient about their medications
•  When collecting information for the patient medication profile
•  In the patient’s preferred pharmacy primary language
•  Unless the patient refuses the service
 
2. Labels & Written Materials
 
Covered pharmacies must provide free translation of:
 
•  Prescription labels
•  Warning labels
•  Other written materials
 
Unless:
 
•  The patient refuses, or
•  Materials already exist in the patient’s language
 
3. How Services May Be Delivered
 
•  May be provided by staff or third‑party contractors
•  Must be provided immediately, but do not need to be in‑person
📢 Posting Requirements
 
Covered pharmacies must post conspicuous notices at each prescription counter:
 
•  Informing LEP individuals of their right to free language services
•  Provided in the pharmacy primary languages
•  Format and placement determined by regulation
 
📦 Mail‑Order Pharmacy Requirements
 
The commissioner must issue regulations (effective one year after enactment) requiring mail‑order pharmacies to provide free language services.
Regulations must address:
 
•  How LEP status will be identified
•  Which languages apply
•  When and how services must be provided
•  What information must be translated/interpreted
•  Utilization, resources, and cost
•  Compliance monitoring and quality standards
 
A report on implementation and issues must be submitted to legislative leaders within two years.
 
🛡️ Liability Protection
 
Covered pharmacies are not liable for injuries caused by third‑party contractors if:
 
•  The contract was entered into reasonably and in good faith
•  The pharmacy was not negligent in supervising or selecting the contractor
 
📝 Waivers
 
Regulations must include a process allowing covered pharmacies to request a waiver from the language‑service requirements if compliance would be unnecessarily burdensome relative to the need.
 
 
This summary page was last updated April 5, 2026

 
Education Law §6830
 
Standardized patient-centered data elements
 
🏷️ Patient‑Centered Prescription Labeling Requirements — Summary
 
📌 Commissioner’s Core Duty
 
•  Develop standardized, patient‑centered data elements for all prescription labels in New York.
•  Standards must align with existing pharmacy technology and equipment.
 
📌 Key Factors the Commissioner Must Consider
 
•  Medical literacy research that improves patient understanding and medication adherence.
•  Clarity of directions for use, including structure and phrasing.
•  Font types and sizes that enhance readability.
•  Limiting content to patient‑centered information only.
•  Needs of special populations, such as individuals with limited English proficiency, disabilities, or low literacy.
 
📌 Required Public Input
 
The commissioner must solicit feedback from:
 
•  State Board of Pharmacy
•  State Board of Medicine
•  Consumer groups
•  Advocates for special populations
•  Pharmacists and physicians
•  Other authorized prescribers
•  Any other interested stakeholders
 
 
This summary page was last updated April 5, 2026

 
Education Law §6831
 
Special provisions relating to outsourcing facilities
 
🧪 Outsourcing Facility Requirements – Summary
 
🏛️ Registration & Scope
 
•  Must be registered as an outsourcing facility under the Federal Food, Drug and Cosmetic Act and under state law.
•  Drugs compounded in a registered outsourcing facility are exempt from FDCA §§ 502(f)(1), 505, and 582 (labeling with adequate directions, new drug approval, and certain supply‑chain requirements).
 
💊 Prescription & Distribution Rules
 
•  An outsourcing facility may not dispense or distribute pursuant to a prescription unless it is also registered as a pharmacy in the state and meets all federal and state pharmacy requirements.
•  All compounded drugs must comply with all applicable federal and state laws.
 
🏷️ Labeling Requirements
 
Each compounded drug label must prominently include:
 
•  Statement identifying the product as a compounded drug.
•  Name, address, phone number of the outsourcing facility.
•  For the drug itself:
  ⁠◦  Lot/batch number
  ⁠◦  Established name
  ⁠◦  Dosage form & strength
  ⁠◦  Quantity/volume
  ⁠◦  Date compounded
  ⁠◦  Expiration date
  ⁠◦  Storage/handling instructions
  ⁠◦  NDC (if available)
  ⁠◦  Statements: “Not for resale” and “Office Use Only”
  ⁠◦  Full list of active & inactive ingredients with quantities/proportions.
 
📦 Container Requirements
 
Containers holding multiple units (e.g., bags of syringes) must include:
 
•  Full ingredient list with quantities/proportions.
•  Any additional information required to support adverse event reporting under 21 CFR 310.305.
 
🧬 Bulk Drug Substance Rules
 
Outsourcing facilities may not compound using bulk drug substances unless:
 
•  The substance appears on the HHS clinical‑need list, or
•  The drug is on the FDA drug shortage list at the time of compounding/distribution/dispensing, and
•  If a USP/NF (or recognized compendium) monograph exists, the substance meets the monograph, and
•  Each bulk substance is manufactured by a federally registered establishment.
 
🧂 Other Ingredients
 
Non‑bulk ingredients must comply with USP/NF monographs or another HHS‑recognized compendium, if available.
 
🚫 Prohibited Compounding Activities
 
•  Unsafe/ineffective drugs: Cannot compound drugs withdrawn/removed from the market for safety or efficacy reasons.
•  Wholesaling: Compounded drugs cannot be sold or transferred by anyone other than the outsourcing facility that made them (administration in healthcare settings and dispensing via prescription are allowed).
•  Copying approved drugs: Cannot compound drugs that are essentially copies of approved drugs.
•  Drugs with demonstrable compounding difficulties: Cannot compound drugs on the HHS list of products that present demonstrable difficulties, unless all listed conditions are met.
 
📣 Reporting Requirements
 
•  Must submit all adverse event reports (as submitted to HHS under 21 CFR 310.305) to the State Board of Pharmacy’s executive secretary.
•  The commissioner (with the health commissioner) must issue a report to the governor and legislature within 18 months evaluating the effectiveness of outsourcing facility oversight.
 
 
 
This summary page was last updated April 5, 2026
 

 
Education Law §6832
 
Limitations on assistance of an unlicensed person
 
🧪 What Unlicensed Pharmacy Staff May Do
 
Under pharmacist supervision, an unlicensed person may perform non‑judgmental, mechanical dispensing functions, including:
 
📥 Prescription Intake & Data Entry
 
•  Receive written or electronic prescriptions, but a pharmacist or intern must review and accept all e‑prescriptions before processing.
•  Type prescription labels.
•  Enter or retrieve prescription data in the computer system, provided the system requires pharmacist verification and initials before dispensing.
 
📦 Medication Handling
 
•  Retrieve drugs from stock and return them to stock.
•  Count dosage units.
•  Place drugs into appropriate containers.
•  Affix labels to containers.
 
🗂 Record & File Management
 
•  Retrieve prescription files or other manual records.
•  Prepare manual dispensing records for the pharmacist’s signature or initials.
 
🤝 Patient Interaction
 
•  Hand completed prescriptions to patients or their agents.
•  Advise patients of the availability of pharmacist counseling (as required by regulation).
 
📝 Other Duties
 
•  Perform additional functions defined by commissioner’s regulations.
 
👥 Supervision & Staffing Ratios
 
Standard Ratio
 
•  A pharmacist may supervise no more than four unlicensed persons at one time.
•  This limit applies to all non‑Article 28 pharmacies.
 
Exemptions
 
•  Pharmacy interns do not count toward the ratio but must be supervised per regulations.
•  Individuals who only place unit‑dose packaged drugs into medication carts in institutional settings are exempt, as long as they do not perform the other listed dispensing tasks.
 
Pharmacist Responsibility
 
•  The pharmacist must provide appropriate supervision to ensure compliance with all regulations.
 
 
This summary page was last updated April 5, 2026