Part 80: Rules and Regulations on Controlled Substances in NYS

Effective Date: Title: Section 80.62 - Use of controlled substances in treatment 80.62 Use of controlled substances in treatment. (a) Physicians and other authorized practitioners in the course of their professional practice, may dispense, administer or prescribe controlled substances for legitimate medical purposes or treatment, other than treatment for addiction to controlled substances, when the practitioner regulates the dosage and prescribes or administers a quantity of such drugs no greater than that ordinarily recognized by members of his profession as sufficient for proper treatment in a given case. (b) Such practitioners shall maintain a written patient record of administration, dispensing and prescription of all controlled substances. The patient record shall contain sufficient information to justify the diagnosis and warrant the treatment. The record shall contain at least the following information: patient identification data; chief complaint; present illness; physical examination as indicated; diagnosis; other data which support the diagnosis or treatment; and the regimen including the amount, strength, and directions for use of the controlled substance. This subdivision shall not be construed to require a record distinct from the medical record of the patient.

80.63 Prescribing. (a) A prescription as defined by the Public Health Law means: (1) an official New York State prescription; (2) a written prescription; or (3) an oral prescription. (b) The use of preprinted prescriptions which indicate the controlled substance or the strength, dosage and/or quantity of the controlled substance is prohibited. (c)(1) No controlled substance prescription shall be issued prior to the examination of the patient by the practitioner except as otherwise permitted by this subdivision. (2) Once the initial examination has been completed, the frequency and necessity for future examinations prior to prescribing, either for the same acute or chronic condition, will be made by the practitioner utilizing generally accepted medical standards, including taking into account the drug to be prescribed and the patient's condition, history and disposition toward the use of controlled substances. (3) In the temporary absence of the initial prescriber, an authorized practitioner may issue a controlled substance prescription for a patient as part of a continuing therapy if the practitioner: (i) had direct access to the patient's medical records and such records warrant continued controlled substance prescribing, or (ii) had direct and adequate consultation with the initial prescriber, who assures the necessity of continued controlled substance prescribing and with which the practitioner concurs. If the patient record is not available, the practitioner shall document the activity for his or her own record and shall transmit to the initial prescriber the prescription information. The initial prescriber shall include the prescription information in the patient's record. (4) A practitioner may prescribe a controlled substance to his or her patient after review of the patient's record if the record contains the result of an examination performed by a consulting physician or hospital and such record warrants the prescribing. (5) If a patient develops a new condition that would warrant the issuance of a prescription for a controlled substance, a practitioner may issue such prescription prior to performing an examination if: (i) the prescribing practitioner has a previously established practitioner/patient relationship with the patient; and (ii) an emergency exists; and (iii) the prescription does not exceed a 5 day supply as determined by the directions for use. An emergency means that the immediate administration of the drug is necessary for the proper treatment of the patient and that no alternative treatment is available. If the prescription is for a substance which requires an official New York State prescription form, and the practitioner prescribes such substance orally, the practitioner must comply with the requirements of section 80.68. If the prescription is for a substance which does not require an official New York State prescription form, and the practitioner prescribes such substance orally, the practitioner must comply with the requirements of section 80.70.

Title: Section 80.71 - Practitioners; dispensing controlled substances 80.71 Practitioner; dispensing controlled substances. (a) Practitioners, in good faith and in the course of their professional practice only, and as limited in this Part may dispense controlled substances. (b) Except as provided in subdivision (c) of this section, the quantity of substances dispensed may not exceed a 30-day supply if the substances were used in accordance with the directions for use. No additional dispensing of a controlled substance may be made by a practitioner to an ultimate user within 30 days of the date of the previous dispensing unless and until the ultimate user has exhausted all but a seven days' supply of that controlled substance previously dispensed. (c)(1) A practitioner may dispense up to a three month supply of a controlled substance, including chorionic gonadotropin, or up to a six month supply of an anabolic steroid if used in accordance with the directions for use, provided that such supply has been dispensed for the treatment of a condition specified in section 80.67(d) and 80.69(d) of this Part. (d) No controlled substance shall be dispensed unless it is enclosed within a suitable and durable container upon which is indelibly typed, printed or otherwise legibly written upon an orange label affixed to such container, in a manner which would inhibit its removal, the following: (1) name and address of the ultimate user for whom the substance is intended, or, if intended for use upon an animal, the species of such animal and the name and address of the owner or person having custody of such animal; (2) name, address and telephone number of the dispensing practitioner; (3) specific directions for use, including but not limited to the dosage and frequency of dosage, and the maximum daily dosage; (4) the legend, prominently marked or printed in either boldface or upper case lettering: "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED"; (5) the date of dispensing; and (6) either the name of the substance or such code number assigned by the department for the particular substance pursuant to section 80.24 of this Part. (e) The practitioner shall submit dispensing information, for all controlled substances dispensed, electronically to the department utilizing a transmission format acceptable to the department by not later than the 15th day of the next month following the month in which the substance was delivered. The information filed with the department shall include but not be limited to: (1) practitioner identifier; (2) patient name;(3) patient address, including street, city, state, ZIP code; (4) patient date of birth; (5) patient’s sex; (6) date controlled substance dispensed; (7) metric quantity; (8) national drug code number of the drug; (9) number of days supply; (10) prescriber's Drug Enforcement Administration (DEA) number; and (11) payment method.