N.Y. Comp. Codes R. & Regs. tit. 10 § 80.69

Current through Register Vol. 46, No. 50, December 11, 2024

Section 80.69 - Schedule iii, iv and v substances

(a) In addition to the requirements set forth in sections 80.67 and 80.70 of this Part, substances in schedule III, IV or V shall be prescribed by a practitioner on an official New York State prescription or, subject to the following, an electronic prescription, in good faith, and in the course of his/her professional practice. Electronic prescriptions may be created, signed and transmitted electronically provided the practitioner complies with all other requirements for issuing controlled substance prescriptions in this Part, and with Federal requirements for electronic prescribing of controlled substances. A prescription generated on an electronic system that is printed out or transmitted via facsimile is not considered an electronic prescription and shall be manually signed.

(b) The prescription shall contain the following:

(1) name, address and age of the ultimate user for whom the substance is intended, or, if the ultimate user is an animal, the species of such animal and the name and address of the owner or person in custody of such animal;

(2) the printed name, address, Drug Enforcement Administration registration number, telephone number and handwritten signature or, in the case of an electronic prescription, the electronic signature of the prescribing practitioner. The printed name of the prescriber who has signed the prescription shall be imprinted or stamped legibly and conspicuously on the prescription, shall appear in an appropriate location on the prescription form and shall not be entered in or upon the space or line reserved for the prescriber's signature. The imprinted or stamped name shall not be a substitute for or fulfill any legal requirement otherwise mandating that the prescription be signed by the prescriber;

(3) specific directions for use, including but not limited to the dosage and frequency of dosage and the maximum daily dosage;

(4) the date upon which such prescription was actually signed by the prescribing practitioner. A prescription shall be dated as of, and signed on, the date when issued; and

(5) the quantity of dosage units prescribed and the number of times that the prescription may be refilled. On an official New York State prescription, the quantity of dosage units and the number of times that the prescription may be refilled shall be indicated in both numerical and written word form.

(6) An electronic prescription shall contain the requirements as provided in paragraphs (1)-(5) of this subdivision except such prescription shall contain an electronic signature and shall be transmitted and received by electronic means. Such electronic signature shall meet the signature requirements set forth in paragraph (2) of this subdivision.

(7) A section wherein prescribers may indicate whether an individual is limited English proficient, as defined in section 6829 of the Education Law; and if the patient is limited English proficient, a specification of the preferred language indicated by the patient. Failure to include such indication on the part of the prescriber shall not invalidate the prescription.

(c) Except as provided in subdivision (d) of this section, no such prescription shall be made for a quantity of substances which would exceed a 30-day supply if the substance were used in accordance with the directions for use, as specified on the prescription. No additional prescriptions for a controlled substance may be issued by a practitioner to an ultimate user within 30 days of the date of any prescription previously issued unless and until the ultimate user has exhausted all but a seven days' supply of that controlled substance provided by any previously issued prescription.

(d)

(1) A practitioner may issue a prescription for up to a three month supply of a controlled substance if used in accordance with the directions for use, provided that the prescription has been issued for the treatment of:

(i) panic disorders, designated as code A;

(ii) attention deficit disorder, designated as code B;

(iii) chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity, designated as code C;

(iv) relief of pain in patients suffering from conditions or diseases known to be chronic or incurable, designated as code D;

(v) narcolepsy, designated as code E; or

(vi) hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, metastatic breast cancer in women, anemia and angioedema, designated as code F.

(2) Such prescription shall specify the condition being treated on the face of the prescription. The practitioner issuing such prescription shall either:

(i) specify the name of such condition on the face of the prescription; or

(ii) specify a code on the prescription to denote the condition for which the prescription has been issued, in accordance with codes issued by the department.

(3) Either the name of the condition or one of the designated codes shall fulfill the requirement in:

(i) section 3332 (3) of the Public Health Law for the specific condition to be given on the face of the prescription; and

(ii) section 3333 (1) of the Public Health Law for the statement that the controlled substance has been prescribed to treat one of the conditions that have been enumerated by the regulations of the commissioner as warranting the prescribing of greater than a 30 days' supply of a controlled substance.

(e) Such official New York State prescription or an out-of-state written prescription for a patient enrolled in a hospice program or for a patient residing in a residential health care facility (RHCF) may be transmitted by the practitioner, or a person authorized by the practitioner, to the dispensing pharmacy by facsimile, provided:

(1) the hospice program or RHCF is licensed or approved by the department;

(2) the dispensing pharmacy has a written agreement or contract with the hospice program or RHCF to dispense controlled substances to a patient of such program or facility;

(3) the practitioner shall note on the prescription that the patient is a "hospice patient" or "RHCF patient"; and

(4) within 72 hours, the prescribing practitioner shall cause to be delivered to the pharmacist the original official New York State prescription or the original out-of-state written prescription. If the pharmacist fails to receive such prescription, he/she shall notify the department in writing or electronically within seven days from the date of dispensing the substance.

(f) An official New York State prescription or an out-of-state written prescription for a schedule III, IV or V controlled substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner, or a person authorized by the practitioner, to the dispensing pharmacy by facsimile. Within 72 hours, the prescribing practitioner shall cause to be delivered to the pharmacist the original official New York State prescription or the original out-of-state written prescription. If the pharmacist fails to receive such prescription, he/she shall notify the department in writing or electronically within seven days from the date of dispensing the substance.

(g) An official New York State prescription, an out-of-state written prescription, or an electronic prescription for a schedule III, IV, or V controlled substance, other than such substances as listed in section 80.67 of this Part, may be refilled, but not more than the number of times specifically authorized by the prescriber upon the prescription; provided, however, no such authorization shall be effective for longer than six months from the date the prescription is signed and that not more than five refills are made. When the initial prescription is issued for a quantity of substance in excess of a 30- day supply under the authority of subdivision (c) of this section, the prescription may only be refilled once.

(h) Unless an earlier refilling is authorized by the prescriber, no prescription shall be refilled earlier than seven days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use.

(i) On refills the dispensing pharmacist shall indicate on the prescription the amount dispensed, the date dispensed, and the signature of the dispensing pharmacist. When refills are recorded in an electronic recordkeeping system:

(1) the pharmacist shall ensure that the computer application used for such recordkeeping shall:

(i) provide online retrieval of original prescription information; and

(ii) provide online retrieval of the current refill history for schedule III, IV and V controlled substance prescriptions.

(2) each time an official New York State prescription or an out-of-state written prescription for a schedule III, IV or V controlled substance is refilled, the dispensing pharmacist shall document that the refill information entered into the computer has been reviewed and is correct by manually signing:

(i) a hard-copy printout of each day's controlled substance prescription refill data; or

(ii) a bound log book containing a statement that the refill information entered into the computer that day has been reviewed and is correct as shown.

(3) When a prescription is received electronically, the prescription and all required annotations shall be retained electronically.

(4) The pharmacy shall employ a procedure to be used for documentation of refills of schedule III, IV and V controlled substance prescriptions in the event of system downtime. The procedure shall ensure that refills are authorized by the original prescription and that the maximum number of refills authorized has not been exceeded.

(j) Prescriptions which indicate pharmacy prescription numbers only of prior controlled substances prescriptions are not valid and shall not be refilled.

(k) Upon expiration of the authorization of the prescription to be refilled or the six month limitation of the prescription, the practitioner shall execute a new prescription if he desires the medication to be continued.

(l) When a prescription prepared by a practitioner is incomplete, the practitioner may orally furnish the missing information to the pharmacist and authorize him or her to enter the missing information on the prescription. The pharmacist shall write the date he or she received the oral authorization on the prescription and shall affix his or her signature. This procedure shall not apply to unsigned or undated prescriptions or where the name and/or quantity of the controlled substances is not specified or where the name of the ultimate user is missing. The pharmacist is not required to obtain authorization from the practitioner to enter the patient's address, sex or age if the pharmacist obtains the information through a good-faith effort.

(m) A practitioner may orally authorize a pharmacist to change information on a controlled substance prescription. This procedure shall not apply to the practitioner's signature, date the prescription was signed by the practitioner, drug name or name of the ultimate user. The pharmacist shall write the date he or she received the oral authorization on the prescription, reason for the change and his or her signature. The pharmacist shall also indicate the change on the prescription and initial the change.

(n) When a pharmacist fills a prescription in a manner that would require, under subdivision (l) or (m) of this section, the pharmacist to make a notation on the prescription if the prescription were written, the pharmacist shall make the same notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record.

(o) When a practitioner is notified that an electronic prescription was not successfully delivered, the practitioner shall ensure that any written or oral prescription issued as a replacement of the original electronic prescription indicates that the prescription was originally transmitted electronically, shall indicate which pharmacy the prescription was originally transmitted to, and that the transmission failed.

(p) If the content of any of the information required by this Part for a controlled substance prescription is altered during the transmission of an electronic prescription, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.69