(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. (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. (2) the name, address and telephone number of the pharmacy from which such substance is dispensed;
3. (3) specific directions for use as stated on the prescription;
4. (4) the name of the prescribing practitioner;
5. (5) the legend, prominently marked or printed in either boldface or upper case lettering: “CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED”;
6. (6) the number of the prescription under which it is recorded in the pharmacy prescription file;
7. (7) the date of filling; and
8. (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.

(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.

1. (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:

   1. (i) pharmacy prescription number;
   2. (ii) pharmacy's national identification number;
   3. (iii) patient name, in the case of an animal, the patient name field shall be filled with the name of the animal’s owner;
   4. (iv) patient address, including street, city, state, ZIP code;
   5. (v) patient date of birth;
   6. (vi) patient's sex;
   7. (vii) date prescription filled;
   8. (viii) metric quantity;
   9. (ix) national drug code number of the drug;
   10. (x) number of days supply;
   11. (xi) prescriber's Drug Enforcement Administration number;
   12. (xii) date prescription issued;
   13. (xiii) serial number of official prescription form, or an identifier designated by the department;
   14. (xiv) payment method;
   15. (xv) number of refills authorized;
   16. (xvi) refill number;
   17. (xvii) species code; and

   18. (xviii) name of animal, if applicable.

       (2)

   19. (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.
   20. (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.

(f)

(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. (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. (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. (3) make a good-faith effort to verify the identity of both the practitioner and the ultimate user;
4. (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. (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.

(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. (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. (2) the patient is a resident in a residential health care facility ("RHCF") which is licensed or approved by the department; or
3. (3) the patient has been diagnosed as being terminally ill;

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

   1. (i) record on the prescription whether the patient is "terminally ill" or is a "RHCF patient"; and
   2. (ii) record on the prescription the date of the partial filling, quantity dispensed, quantity remaining and the signature of the dispensing pharmacist;
5. (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. (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.