N.Y. Comp. Codes R. & Regs. tit. 10 § 80.73

Current through Register Vol. 46, No. 51, December 18, 2024

Section 80.73 - Pharmacists; dispensing schedule ii substances and certain other controlled substances

(a) A licensed, registered pharmacist, or a pharmacy intern acting in conformity with the provisions of section 6806 of the Education Law and regulations thereunder in a registered pharmacy, may, in good faith and in the course of his/her professional practice, sell and dispense to an ultimate user schedule II controlled substances or those schedule III or schedule IV controlled substances listed in section 80.67(a) of this Part, provided they are dispensed pursuant to an official New York State prescription, an out-of-state prescription or an electronic prescription delivered within 30 days of the date such prescription was signed by the authorized practitioner or an oral prescription where permitted.

(b) No such substance shall be dispensed or sold unless it is enclosed within a suitable and durable container to which is affixed, in such a manner which would inhibit its removal, an orange label upon which is indelibly typed, printed or otherwise legibly written:

(1) the 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) the name, address and telephone number of the pharmacy from which such substance is dispensed;

(3) specific directions for use as stated on the prescription;

(4) the name of the prescribing practitioner;

(5) the legend, prominently marked or printed in either boldface or upper case lettering: "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED";

(6) the number of the prescription under which it is recorded in the pharmacy prescription file;

(7) the date of filling; and

(8) the name of the controlled substance or such code number assigned by the department for the particular substance pursuant to section 80.24 of this Part.

(c) A licensed, registered pharmacist in a registered pharmacy may, in good faith and in the course of his/her professional practice, sell and dispense, to an ultimate user, controlled substances upon the delivery to such pharmacist, within 30 days of the date such prescription was issued by an authorized practitioner, an official New York State prescription or an out-of-state written prescription transmitted by facsimile in accordance with section 80.67(e) or (f) of this Part.

(d) The pharmacist filling the prescription shall endorse upon the prescription his/her signature, the date of filling, and the number of the prescription under which it is recorded in the pharmacy prescription file.

(e) A pharmacy shall make a good faith effort to verify the identity of any person accepting delivery of a dispensed prescription for a controlled substance by requiring such person, if unknown to the pharmacy, to present appropriate identification.

(f)

(1) The endorsed prescription shall be retained by the proprietor of the pharmacy for a period of five years. The prescription information shall be filed electronically with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the department, not later than 24 hours after the substance was delivered. A waiver allowing a pharmacy to make such filings within a longer period of time may be issued by the commissioner based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the pharmacy, or other exceptional circumstance demonstrated by the pharmacy. Such waiver and any subsequent waiver shall be applied for in the same manner and shall be subject to the same requirements as specified in section 80.63(c)(2)(x) of this Part and, if granted, such waiver shall not provide for a filing period longer than the 15th day of the next month following the month in which the substance was delivered. Pharmacies delivering prescriptions by mail or licensed express delivery services shall file the prescription information with the Bureau of Narcotic Enforcement, utilizing a transmission format acceptable to the department, not later than 72 hours after the substance was shipped from the pharmacy. The information filed with the department shall include but not be limited to:

(i) pharmacy prescription number;

(ii) pharmacy's national identification number;

(iii) patient name, in the case of an animal, the patient name field shall be filled with the name of the animal's owner;

(iv) patient address, including street, city, state, ZIP code;

(v) patient date of birth;

(vi) patient's sex;

(vii) date prescription filled;

(viii) metric quantity;

(ix) national drug code number of the drug;

(x) number of days supply;

(xi) prescriber's Drug Enforcement Administration number;

(xii) date prescription issued;

(xiii) serial number of official prescription form, or an identifier designated by the department;

(xiv) payment method;

(xv) number of refills authorized;

(xvi) refill number;

(xvii) species code; and

(xviii) name of animal, if applicable.

(2)

(i) When applicable, pharmacies and dispensing practitioners shall file a zero report with the Bureau of Narcotic Enforcement in a format acceptable to the department. For the purposes of this Part, a zero report shall be a report that no controlled substances were dispensed by a pharmacy or dispensing practitioner during the relevant period of time. A zero report shall be submitted no later than 14 days following the most recent previously reported dispensing of a controlled substance, the submission of a prior zero report, or the termination of a waiver of the requirement to file a zero report.

(ii) A waiver of the requirement to file a zero report may be issued by the commissioner based upon a showing that a pharmacy or practitioner does not dispense controlled substances within the State of New York. The request for a waiver shall include a sworn statement of facts detailing the circumstances in support of a waiver, and should be accompanied by any and all other information which would be relevant to the commissioner's determination, as well as any information which would tend to negate the need for a waiver. A waiver granted by the commissioner shall be for a specified period of time, but in no event for more than two years. Subsequent waivers shall be applied for in the same manner and shall be subject to the same requirements set forth above. A pharmacy or practitioner who has been granted a waiver shall notify the department in writing within five business days of any change in circumstances that would result in the possible dispensing of a controlled substance. The waiver granted to the pharmacy or practitioner shall be terminated effective the date of notification, and the pharmacy or practitioner shall comply with all reporting requirements of this Part until or unless a subsequent waiver is granted.

(g) Emergency oral prescriptions for schedule II controlled substances or those schedule III or schedule IV controlled substances listed in section 80.67(a) of this Part may be dispensed by a pharmacist to an ultimate user in an emergency situation, provided the pharmacist shall:

(1) contemporaneously reduce such prescriptions to written memoranda or, to the extent authorized by Federal requirements, to an electronic record and shall indicate on such memoranda the name and address of the prescriber and his/her Drug Enforcement Administration registration number, name and address of the ultimate user, date on which it is ordered, name and quantity of drugs prescribed, directions for use and the fact that it is a telephone order. The memoranda or electronic record for such emergency oral prescription shall be filed in the same manner as is otherwise required for such prescription. The pharmacist filling such oral orders shall indicate on the face of such telephone order his/her signature, the date filled and the number of the prescription under which it is recorded in the pharmacy prescription file;

(2) dispense the substance in conformity with labeling requirements applicable to the type of prescription which would be required but for the emergency; and

(3) make a good-faith effort to verify the identity of both the practitioner and the ultimate user;

(4) no emergency oral prescription shall be filled for a quantity of controlled substances which would exceed a five-day supply if the substance were used in accordance with the directions for use;

(5) within 72 hours after authorizing an emergency oral prescription, the prescribing practitioner shall cause to be delivered to the pharmacist a written or an electronic prescription. Such prescription shall, in addition to the information otherwise required, also have written or typed upon its face the words: "Authorization for emergency dispensing". 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.

(h) Within 72 hours after transmitting a prescription to a pharmacist by facsimile in accordance with section 80.67(e) or (f) of this Part, the prescribing practitioner shall cause to be delivered to the pharmacist the original official New York State prescription or an original out-of-state written prescription. Such original prescription shall be attached to any prescription transmitted by facsimile. 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.

(i) Such prescriptions shall be endorsed, retained and filed in the same manner as is otherwise required for such prescriptions. The follow-up prescriptions shall be attached to, or otherwise associated with, the corresponding memoranda of oral orders or to prescriptions transmitted by facsimile. The information required in section 80.68(d)(2) of this Part shall be filed electronically with the New York State Department of Health, not later than 24 hours after the substance was delivered. The pharmacy must submit this information electronically to the department utilizing a transmission format acceptable to the department. A waiver allowing a pharmacy to make such filings within a longer period of time may be issued by the commissioner based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the pharmacy, or other exceptional circumstance demonstrated by the pharmacy. Such waiver and any subsequent waiver shall be applied for in the same manner and shall be subject to the same requirements as specified in section 80.63(c)(2)(x) of this Part and, if granted, such waiver shall not provide for a filing period longer than the 15th day of the next month following the month in which the substance was delivered.

(j) A pharmacist may partially fill an official New York State prescription for a schedule II controlled substance or those schedule III or schedule IV controlled substances listed in section 80.67(a) of this Part provided that:

(1) the pharmacist does not have a sufficient quantity to fill a prescription and he/she makes a notation of the quantity supplied on the prescription. The remaining portion of the prescription may be filled within 72 hours of the first partial filling. However, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription;

(2) the patient is a resident in a residential health care facility ("RHCF") which is licensed or approved by the department; or

(3) the patient has been diagnosed as being terminally ill;

(4) when such prescription is partially filled in accordance with paragraph (2) or (3) of this subdivision, the pharmacist shall:

(i) record on the prescription whether the patient is "terminally ill" or is a "RHCF patient"; and

(ii) record on the prescription the date of the partial filling, quantity dispensed, quantity remaining and the signature of the dispensing pharmacist;

(5) the prescription shall be valid for a period not to exceed 30 days from the date the prescription was issued by the practitioner unless terminated sooner upon notification from the practitioner of the discontinuance of medication. All partial fillings filled under subdivision (l) of this section must occur within 30 days from the date the prescription was issued, except that partial fillings of prescriptions issued for more than a 30 day supply for patients residing in a residential healthcare facility or for patients enrolled in a hospice program that is licensed or approved by the department must occur within 60 days from the date the prescription was issued.

(6) the date of filling on the prescription shall be the date when the prescription has been filled to completion or the date when the pharmacy is notified by the practitioner that the prescription has been discontinued.

(k) When an official New York State prescription or an out-of-state written 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 such 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 substance 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 this information through a good-faith effort.

(l) A practitioner may orally authorize a pharmacist to change information on an official New York State prescription or an out-of-state written 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.

(m) When a pharmacist fills a prescription in a manner that would require, under subdivision (k) or (l) 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.

(n) When a pharmacist receives a written or an oral prescription for a schedule II controlled substance or those schedule III or schedule IV controlled substances listed in section 80.67(a) of this Part that indicates that it was originally transmitted electronically to the pharmacy, the pharmacist shall conduct a reasonable search of the pharmacy records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist shall mark one as void.

(o) When a pharmacist receives a written or an oral prescription for a schedule II controlled substance or those schedule III or schedule IV controlled substances listed in section 80.67(a) of this Part that indicates that it was originally transmitted electronically to a separate pharmacy, the pharmacist shall confer with the separate pharmacy to determine if the separate pharmacy received that prescription and if the separate pharmacy dispensed upon that electronic prescription. If the separate pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy shall mark the electronic version as void or cancelled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy receiving the written or oral version shall not dispense the prescription and shall mark it as void.

(p) A pharmacist shall use a pharmacy computer application that meets Federal security requirements to process electronic controlled substance prescriptions and shall register such pharmacy computer application with the New York State Department of Health, Bureau of Narcotic Enforcement.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.73