10 N.Y.C.R.R. § 80.63(d).
4. Electronic Prescribing Requirement
Effective March 27, 2016 electronic prescribing of controlled substances and non-controlled substances is required, subject to limited exceptions. Computer applications utilized to prescribe controlled substances must meet federal security requirements. Computer applications that meet federal security requirements must be registered with the Department of Health Bureau of Narcotic Enforcement.
Public Health Law §281; 3302(37); 10 N.Y.C.R.R. § 80.64(b).
Prescriptions excepted from the electronic prescribing requirement include prescriptions:
(1) Issued by veterinarians
(2) Issued are circumstances where electronic prescribing is not available due to temporary technological or electrical failure. Temporary technological or electrical failure is defined as any failure of a computer system, application, or device, or the loss of electrical power to that system, application, or device, or any other service interruption to a computer system, application, or device in such manner that it reasonably prevents a practitioner from utilizing his or her certified electronic prescribing application to transmit on electronic prescription for a controlled substance.
(3) Issued by practitioner to whom the Commissioner of Health has granted a waiver.
(4) Issued by a practitioner under circumstances where such practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient’s medical condition, provided that if such prescription is for a controlled substance, the quantity of controlled substances does not exceed a 5 day supply.
(5) Issued by a practitioner to be dispensed by a pharmacy out of state.
For more information go to the N.Y.S. Department of Health website.
Practitioner Reporting Requirement
EFFECTIVE SEPTEMBER 30, 2016:
Use of an exception to the e-prescribing mandate no longer requires a notification to the New York State Department of Health. However, the prescribing practitioner must indicate in the patient’s health record when they issue a non-electronic prescription for one of the approved exceptions below:
o Temporary technological failure;
o Temporary electronic failure;
o To be dispensed by a pharmacy located outside the state, outside the country, or on federal property, including and not limited to the following examples; Veterans Administration, West Point, Fort Drum, and Indian Reservations;
o The practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient’s medical condition.
Additional Exceptions to Electronic Prescribing Requirement
By letter dated March 16, 2016, the NYS Department of Health informed practitioners and pharmacists of a blanket waiver with respect to the electronic prescribing requirements for exceptional circumstances in which electronic prescribing cannot be performed due to limitations in software functionality. The Department of Health waived the following exceptional circumstances from the electronic prescribing requirement:
1. any practitioner prescribing a controlled or non-controlled substance, containing two (2) or more products, which is compounded by a pharmacist;
2. any practitioner prescribing a controlled or non-controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;
3. any practitioner prescribing a controlled or non-controlled substance that contains long or complicated directions;
4. any practitioner prescribing a controlled or non-controlled substance that requires a prescription to contain certain elements required by the federal Food and Drug Administration (FDA) that are not able to be accomplished with electronic prescribing;
5. any practitioner prescribing a controlled or non-controlled substance under approved protocols under expedited partner therapy, collaborative drug management or in response to a public health emergency that would allow a non-patient specific prescription;
6. any practitioner prescribing an opioid antagonist that would allow a non-patient specific prescription;
7. any practitioner prescribing a controlled or non-controlled substance under a research protocol;
8. a practitioner prescribing a controlled or non-controlled substance either through an Official New York State Prescription form or an oral prescription communicated to a pharmacist serving as a vendor of pharmaceutical services, by an agent who is a health care practitioner, for patients in nursing homes and residential health care facilities as defined in section twenty-eight hundred one of the public health law.
9. a pharmacist dispensing controlled and non-controlled substance compounded prescriptions, prescriptions containing long or complicated directions, and prescriptions containing certain elements required by the FDA or any other governmental agency that are not able to be accomplished with electronic prescribing;
10. a pharmacist dispensing prescriptions issued under a research protocol, or under approved protocols for expedited partner therapy, or for collaborative drug management;
11. a pharmacist dispensing non-patient specific prescriptions, including opioid antagonists, or prescriptions issued in response to a public health emergency issued; and
12. a pharmacist serving as a vendor of pharmaceutical services dispensing a controlled or non-controlled substance through an Official New York State Prescription form or an oral prescription communicated by an agent who is a health care practitioner, for patients in nursing homes and residential health care facilities as defined in section twenty-eight hundred one of the public health law.
Practitioners issuing prescriptions in the above-listed exceptional circumstances may either use the Official New York State Prescription Form or issue an oral prescription; provided, however, that oral prescriptions remain subject to § 3334 and § 3337 of the PHL, which provide for oral prescriptions of controlled substances in emergencies and for other limited purposes, and subject to § 6810 of the Education Law. Pharmacists may dispense prescriptions issued on the Official New York State Prescription Form or oral prescriptions in the above-listed exceptional circumstances.
Frequently asked questions:
New Waiver FAQs 133-135
Also see New York State Department of Education Office of the Professions FAQs Electronic Transmittal of Prescriptions in NYS
5. Legitimate Medical Purpose
A prescription may be issued for legitimate medical purposes only. The responsibility for the proper prescribing and dispensing of controlled substances is placed upon the physician or other authorized practitioner, but a corresponding liability is placed on the pharmacist who fills the prescription.
10 N.Y.C.R.R. § 80.65.
6. Prescription Requirements
There are differing requirements for prescriptions depending upon the schedule. Schedule II and certain substances known as Benzodiazepines - 10 N.Y.C.R.R. § 80.67.
Emergency oral prescriptions for Schedule II, Substances and Benzodiazepines - 10 N.Y.C.R.R.§ 80.68.
Schedule III, IV, and V substances - 10 N.Y.C.R.R. § 80.69.
Oral Prescriptions for Schedule III, IV and V substances - 10 N.Y.C.R.R. § 80.70.
These regulations are available at the website of the NYS Department of Health at www.health.ny.gov/. Click "Laws and Regulations", then select "Title 10".
7. Dispensing Requirements
Dispensing of controlled substances must comply with 10 N.Y.C.R.R. § 80.71. With limited exceptions, the quantity dispensed may not exceed a 30 day supply.
When dispensing a controlled substance, the physician or other practitioner must submit dispensing information for all controlled substances dispensed, electronically to the Department of Health, utilizing a transmission format acceptable to the Department, not later than 24 hours after the substance was delivered. The Department may issue a waiver to allow a physician or other practitioner to make such filing within a longer period of time upon showing of economic hardship, technological limitations that are not reasonably within the control of the physician or practitioner, or other exceptional circumstances. If the waiver is granted, the filing period will not exceed the 15th day of the next month following the month in which the substance was delivered. The information that must be filed with the Department includes, but is not limited to:
1. Dispenser identifier
2. Patient name
3. Patient address
4. Patient date of birth
5. Patient’s gender
6. Date of controlled substance dispensed
7. Metric quantity
8. National drug code number of the drug
9. Number of days’ supply
10. Prescriber’s DEA number
11. Payment method and
12. Species code
When applicable, a physician or practitioner must file a “zero report” with the Department. A zero report is a report that states no controlled substance was dispensed during the relevant period of time. - 10 N.Y.C.R.R. § 80.71.
8. Addicts or Habitual Users
Controlled substances may not be prescribed for, or administered or dispensed to, addicts or habitual users of controlled substances except as permitted by a specific provision in the Public Health Law or Department of Health regulations.
Public Health Law § 3350; 10 N.Y.C.R.R. § 80.76.