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Pharmacy Establishments

Registration

Federal and State laws regulate all pharmacies, wholesalers, repackers and manufacturers that manufacture, distribute and dispense prescriptions drugs and prescription devices. New York State registers establishments as “in state” resident establishments and “out of state” non-resident establishments.

Resident “in state” Establishments

Under New York State Law, the State Board of Pharmacy registers pharmacy, wholesaler, repacker and manufacturer establishments in New York State. New York is the home state for these establishments that are physically located in this state. The Department of Education registers approximately 4,600 pharmacies and 650 drug manufacturers, repackers, and wholesalers that are located in this state.

Non-Resident “out of state” Establishments

New York State Law requires that the State Board of Pharmacy registers all pharmacies, manufactures, repackers and wholesalers that are physically located out of New York State but ship, mail or deliver prescription drugs or prescription devices into New York State. Our non- resident registration law went into effect on March 19, 2003. In the first year we registered approximately 200 pharmacies and 450 manufacturers, repackers, and wholesalers.

Registration ensures public oversight of these businesses, supports the issuance of related permits, assures delivery of prescription drugs to properly authorized facilities, and provides a means of assuring the purity, potency and safety of medications distributed in New York State.

Consumer Complaints

Licensed professionals who provide services that are grossly negligent or incompetent are engaging in "professional misconduct". In New York State, professional misconduct in all the professions (except medicine) is investigated and prosecuted by the New York State Education Department's Office of the Professions (OP). Misconduct by physicians, physician assistants and specialist assistants is investigated and prosecuted by the Office of Professional Medical Conduct (OPMC) of the Department of Health. OP also investigates allegations of illegal or unlicensed practice in all the 38 licensed professions, including physicians, physician assistants, and specialist assistants. Persons practicing illegally represent a risk to the public safety and welfare. Illegal practice is a felony in New York State.

Consumer complaints against registered establishments or pharmacists can be made by contacting the Office of Professional Discipline at one of its offices throughout New York State. For the fastest response, complete a complaint form and contact the office closest to you. You may also telephone toll-free at 1-800-442-8106, fax (212) 951-6449, or email: conduct@mail.nysed.gov.

You may search past decisions of individual discipline cases by name or by month of action.

Supervising Pharmacists

Responsibilities

Responsibility for conformance with all laws and regulations applicable to the conduct of a pharmacy is placed upon the ownership of the pharmacy and upon a licensed pharmacist who is designated by the owner as the Supervising Pharmacist (Pharmacist in Charge). Both must sign the application for the initial registration and registration renewal of a pharmacy. It is the Supervising Pharmacist who is looked upon as the knowledgeable person who will direct and control the practice of pharmacy in the registered pharmacy. The direction and control extends to all persons associated with the pharmacy. The Supervising Pharmacist oversees the practice of other employed pharmacists and insures that unlicensed persons do not engage in unlawful activity [see Rules of the Board of Regents Part 29.7 (a) (21)]. If a supervising pharmacist leaves the site of practice, a new supervising pharmacist must be designated immediately.

A pharmacist may be designated the Supervisor of only one pharmacy or other registered establishment [Education Law 6808 (2) (e)] and must be employed as a practicing pharmacist full time (30 or more hours per week) [Rules of the Board of Regents Part 29.7 (a) (10)]. The pharmacist's role must be an active one in the conduct of the pharmacy and not a passive one.

The Supervising Pharmacist may not assign his/her responsibility to others. A pharmacist who is unable or unwilling to assume the responsibilities of the title of Supervising Pharmacist should not accept this appointment.

The Supervising Pharmacist must be aware of all laws and regulations and must instruct and direct others in order to insure compliance. A Supervising Pharmacist who ceases to serve in that capacity should notify the Board immediately for their own protection. It is the responsibility of the ownership to designate a successor immediately and notify the State Board of Pharmacy within seven days [see Education Law 6808 (2) (c) and Rules of the Board of Regents Section 29.7 (a) (10)].

Notice of Change of Supervising Pharmacist (You may download and print this form* - formph205.pdf; 6K; 1 page)

*Note: This form is in Adobe Acrobat Portable Document Format (PDF). To view or print it, you will need to have the free Acrobat Reader installed on your computer. Download times and print quality will depend on your connection speed and printer.

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The responsibilities of the Supervising Pharmacist include but are not limited to the following:

Supervise and provide for the proper storage, sale, dispensing and compounding of drugs, poisons and restricted devices (i. e. hypodermic syringes and needles).
Insure against unauthorized refills of prescriptions and unauthorized sale of legend drugs.
Use "reasonable" means to determine that the drugs held for sale meet established standards (Federal & State). Eliminate from stock all misbranded and adulterated drugs including outdated drugs and drugs not properly labeled.
Maintain all records in the proper form relating to the purchase and dispensing of all prescription required drugs, including controlled substances.
Insure that no prescription required drugs or devices are sold at wholesale unless the pharmacy possesses a New York State Board of Pharmacy Wholesaler registration.
Insure coverage of the pharmacy by licensed pharmacists.
Insure appropriate security of the pharmacy's dispensing and compounding area, and the drugs and patient records contained therein.

Unprofessional Conduct by Supervising Pharmacists

Rules of the Board of Regents 29.7 (a) (10)

Unprofessional conduct in the practice of pharmacy shall include the following:

(10) failure by a supervising pharmacist to provide adequate supervision of a registered establishment. A supervising pharmacist must be a full-time employee of the establishment. For the purposes of this section, full time shall be deemed to be thirty or more hours per week. In those circumstances in which an establishment operates for less than thirty hours per week, the supervising pharmacist shall be employed for a majority of the hours that the establishment operates. The State Board of Pharmacy shall be notified within seven days of any change in the identity of the supervising pharmacist of a registered establishment. Such notification shall be made by the owner of the registered establishment.