8 CRR-NY 29.7NY-CRR
8 CRR-NY 29.7
8 CRR-NY 29.7
29.7 Special provisions for the professions of pharmacy and registered pharmacy technicians.
(a) The requirements of this section set forth for written prescriptions shall also be applicable to electronic prescriptions, as defined in section 63.6(a)(7)(i)(a) of this Title, unless otherwise indicated. For purposes of this section signature shall include an electronic signature, as defined in section 63.6(a)(7)(i)(c) of this Title, when applicable, and sign shall include the affixing of an electronic signature. Unprofessional conduct in the practice of pharmacy shall include all conduct prohibited by sections 29.1 and 29.2 of this Part except as provided in this section, and shall also include the following:
(1) Dispensing a written prescription which does not bear the name, address and age of the patient for whom it is intended; the date on which it was written; the name, strength, if applicable, and the quantity of the drug prescribed; directions for use, if applicable; and, the name, address, telephone number, profession and signature of the prescriber; provided that the pharmacist may record on the prescription the address and age of the patient, the strength and quantity of the drug prescribed, the directions for use and the prescriber's address, telephone number and profession if these are missing or unclear. If the address and age of the patient and the address, telephone number and profession of the prescriber are missing from the prescription, the pharmacist shall not be required to enter any of these items on the prescription if the information is otherwise readily available in the records of the pharmacy. Prescription labels must be legible. An order for a drug to be dispensed for an inpatient in a health care facility by the pharmacy of that facility may be transmitted to the pharmacy in accordance with written procedures approved by the medical or other authorized board of the facility. The items of information required by this paragraph which are found in the records regularly maintained by the facility and which are not essential to the execution of the order need not appear on the order which is transmitted to the pharmacy. A drug which is dispensed for an inpatient in a health care facility by the pharmacy of that facility may be labeled in accordance with the policy adopted by the medical or other authorized board of the facility. That policy shall insure that all the information required by law to be placed on prescription labels is readily available to all concerned parties and that accuracy and safety prevail in the dispensing process. The address of a patient in a hospital or other health care facility may, for the purpose of a prescription, be that of the facility. An order for a drug for a particular patient issued by a practitioner authorized to prescribe, and transmitted to a pharmacy for dispensing, shall constitute a prescription. Prescriptions written for controlled substances shall meet the requirements of article 33 of the Public Health Law.
(2) Failure by a pharmacist to reduce to writing, either through written communication or electronic record, a prescription transmitted orally, which writing or electronic record shall include all the information required by paragraph (1) of this subdivision and the signature, or the electronic equivalent of a signature, or readily identifiable initials of the receiver of the oral prescription, provided that oral prescriptions for controlled substances shall meet the requirements of article 33 of the Public Health Law.
(3) Failure by a pharmacist dispensing a prescription to enter on the prescription the date of dispensing and to sign or initial legibly the prescription in such a manner as not to interfere with any other information on the prescription; provided that when the prescription is dispensed by an intern, the prescription shall bear the signature or readily identifiable initials of the intern and of the pharmacist who is supervising the intern.
(4) Refilling a prescription without entering on the reverse of the prescription or within the electronic record the date of the refill and the signature or readily identifiable initials of the pharmacist and of the intern, if applicable, dispensing the refill, except as provided in paragraph (8) of this subdivision. As a refill instruction, the pharmacist may accept a number of times, a time period, such as one year, or the Latin phrase pro re nata (abbreviated prn— meaning “as needed”). In the case of the latter, the pharmacist shall refill the prescription once only. The pharmacist receiving on oral order to refill a prescription shall reduce the order to writing or to an electronic record and shall sign or initial it legibly as the recipient of the oral order. When a prescription is refilled, the date placed on the label shall be the date of the refill.
(5) Using or substituting without authorization one or more drugs in the place of the drug or drugs specified in a prescription. Unauthorized use or substitution occurs if the same is done without the knowledge and consent of the prescriber. If other than the ingredients specified are utilized by the pharmacist in compounding or dispensing the prescription, improper substitution shall be presumed unless there shall be entered upon the reverse of the original prescription or within the electronic record information setting forth the facts of the substitution, the date, time and manner in which authorization for substitution was given and the signature of the pharmacist who received such authorization.
(6) Failure to identify a generic product or interchangeable biological product dispensed on a prescription by writing the name of the manufacturer and of the distributor, if different, on the prescription and on the label, except as otherwise provided in Education Law, section 6816-a(1)(c) and 6816-a(3)(c).
(7) Failure to number prescriptions consecutively and file them in a numerical or other form which provides for ready retrieval of the prescriptions; provided that orders for drugs to be dispensed for inpatients in a health care facility, including but not limited to a general hospital, in the pharmacy of that facility under a drug distribution system approved by the medical or other authorized board of the facility, need not be numbered if the orders are otherwise readily available and retrievable; and, provided further that prescriptions for controlled substances shall be filed in accordance with the provisions of article 33 of the Public Health Law.
(8) Failure to maintain in a form which provides for ready retrieval of prescriptions a daily record of all prescriptions filled and refilled which identifies clearly the practitioner who ordered the prescription, the patient for whom the prescription is intended, the signature or readily identifiable initials of the pharmacist who filled or refilled the prescription, and the number assigned to the prescription where applicable. The record of the dispensing of a drug for an inpatient in a health care facility, including but not limited to general hospital, by the pharmacy of that facility may be maintained in a form which is consistent with the record of the total health service provided to the patient provided the information required by this paragraph is readily retrievable and available. Original prescriptions filed in accordance with the provisions of paragraph (7) of this subdivision may constitute the record of the initial filling of those prescriptions. The daily record may be maintained by a manual system or, alternatively, by an electronic data processing system which meets the following requirements:
(i) The system shall provide adequate safeguards against improper manipulation or alteration of stored records.
(ii) Arrangements shall be made which assure completeness and continuity of prescription records if the relationship between a pharmacy and a supplier of data processing services terminates for any reason.
(iii) The system shall provide retrieval of information regarding original dispensing and the refilling of prescriptions.
(iv) A pharmacist, and a pharmacy intern, if applicable, using a computerized system shall sign or initial the original prescription at the time of the first dispensing as provided in paragraph (3) of this subdivision and the signature or initials of the pharmacist shall be entered into the computer record of the dispensing.
(v) For all refills of a prescription, the records introduced into the system shall be sufficient if:
(a) the signature or initials of the pharmacist who dispensed the refill are entered by such pharmacist at the time of dispensing; and
(b) a printout or electronic record is produced of all prescriptions filled and refilled each day and the pharmacist(s) whose signature or initials appear(s) on the printout sign(s), either manually or electronically, the printout or electronic record to indicate that it is an accurate record.
(vi) A pharmacy that employs a computerized system shall have an auxiliary procedure which shall be used for documentation of all new and refilled prescriptions dispensed during system downtime. The auxiliary procedure shall provide for the entry into the computer of all data collected during the downtime, and the pharmacist shall insure that the maximum number of refills authorized on the original prescription has not been exceeded.
(vii) Only pharmacists and pharmacy interns shall enter prescription data into the computerized system and access the data, except as provided in paragraph (21) of this subdivision.
(9) Except as otherwise provided in 16 CFR part 1700 (Code of Federal Regulations, 1984 edition, Superintendent of Public Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, Room 3035, Cultural Education Center, Albany, NY 12230), failure to package a drug in a child-resistant container unless either the prescriber or the patient requests otherwise. Such request shall be documented in the records of the pharmacy. Child-resistant containers shall not be reused.
(10) Failure by a supervising pharmacist to provide adequate supervision of a registered establishment. A supervising pharmacist must be a full-time employee of the establishment. For the purposes of this section, full-time shall be deemed to be 30 or more hours per week. In those circumstances in which an establishment operates for less than 30 hours per week, the supervising pharmacist shall be employed for a majority of the hours that the establishment operates. The State Board of Pharmacy shall be notified within seven days of any change in the identity of the supervising pharmacist of a registered establishment. Such notification shall be made by the owner of the registered establishment.
(11) Advertisements of the prices of prescription drugs which do not comply with the following provisions:
(i) The advertised price shall be in effect for a period of time stated in the advertisement.
(ii) When the advertising of prescription prices forms part of a larger advertisement which includes the offering of general merchandise, the advertising pertaining to prescription prices shall be separated physically, such as by a box, from the advertising pertaining to general merchandise.
(iii) Nothing in this subdivision shall be construed to prevent the use in advertising of a statement to the effect that the price for which any prescription will be filled is available on request.
(iv) Such advertisement shall comply with the “Prescription Drug Consumer Price Listing” requirements set forth in section 200.200 of title 21 of the Code of Federal Regulations (1984 edition, Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, Room 3035, Cultural Education Center, Albany, NY 12230).
(12) Advertising or soliciting professional practice by means of providing physicians, or others authorized to prescribe, with prescription blanks imprinted with either the name of the pharmacist or the name of the pharmacy.
(13) Failing to make prescription fee or price information readily available by providing such information upon request and upon the presentation of a prescription for pricing or dispensing. Nothing in this section shall be construed to prohibit the quotation of price information on a prescription drug to a potential consumer by telephone.
(14) Placing in stock of any pharmacy any part of any prescription compounded or dispensed which is returned by a patient; provided, however, that in a health care facility, including but not limited to a general hospital, which has its own pharmacy and in which unit- dose medication is dispensed to inpatients, each dose being individually sealed and labeled with the name of the drug, dosage strength, manufacturer's control number and expiration date, the unused unit dose of medication may be returned to the pharmacy of the facility for redispensing; and provided further that unused medication may be returned to pharmacies by residential health care facilities in accordance with the provisions of 10 NYCRR 415.18(f) or by other facilities, including but not limited to county correctional facilities, provided that such other facilities utilize standards, policies and procedures determined by the State Board of Pharmacy to be equivalent to those enumerated in 10 NYCRR 415.18(f).
(i) Repacking of drugs in a pharmacy, except by a pharmacist or under his/her immediate and personal supervision. Labels on repacked drugs shall bear sufficient information for proper identification and safety. A repacking record shall be maintained, including the name, strength, lot number, quantity and name of the manufacturer and/or distributor of the drug repacked, the date of the repacking, the number of packages prepared, the number of dosage units in each package, the signature of the person performing the repackaging operation, the signature of the pharmacist who supervised the repacking, and such other identifying marks added by the pharmacy for internal recordkeeping purposes. Drugs repacked for in-house use only shall have an expiration date of 12 months, or 50 percent of the time remaining to the manufacturer's expiration date, whichever is less, from the date of repacking. For the repacking of drugs by manufacturers and wholesalers, the provisions of parts 210 and 211 of title 21, Code of Federal Regulations (1984 edition, Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, 89 Washington Avenue, 2nd Floor, Albany, NY 12234), shall apply. Repacking records shall be maintained for five years and shall be made available to the department for review and copying.
(ii) Repacking drugs in customized patient medication packages (patient med-pak or patient medication package) unless the following conditions are complied with:
(a) medications are packaged in moisture-proof containers that are either non-reclosable or are designed to show evidence of having been opened;
(b) medications are dispensed in containers that bear a label affixed to the immediate container in which the medications are dispensed in accordance with section 6810(1) of the Education Law. Such label shall include:
(1) all information required by Education Law section 6810(1);
(2) the name, strength, physical description or identification, and quantity of each medication;
(3) the address and telephone number of the dispenser;
(4) an expiration date for the customized patient medication package, which shall not be longer than the shortest recommended expiration date of the medications included therein, provided that in no event shall the expiration date be more than 60 days from the date of preparation of the package and shall not exceed the shortest expiration date on the original manufacturer's bulk containers for the dosage forms included therein;
(5) a separate identifying serial number for each of the prescription orders for each of the drug products contained in the customized patient medication package and, unless such number provides complete information about the customized patient medication package, a serial number for the customized patient medication package itself; and
(6) any other information, including storage instructions or any statements, or warnings required for the medications contained in the package;
(c) medications shall not be repackaged for or reissued to any patient other than to the patient for whom they are originally dispensed;
(d) medications shall not be dispensed in customized patient medication packages, without the consent of the patient, the patient's caregiver, or the prescriber, and the patient or caregiver shall be properly instructed in the use of such packages, in how to identify each medication, and in the steps to be taken in the event one of the medications is discontinued or the therapy otherwise altered;
(e) controlled substances shall not be dispensed in customized patient medication packages;
(f) medications that are unstable or therapeutically incompatible shall not be dispensed in customized patient medication packages; and
(g) a record of each customized patient medication package shall be maintained by the pharmacist. Each record shall contain:
(1) the name and address of the patient;
(2) the serial number of the prescription order for each medication contained therein, or other means of individualized tracking system acceptable to the department;
(3) the name of the manufacturer or labeler and the lot number for each medication contained therein;
(4) information identifying or describing the design, characteristics, or specifications of the customized patient medication package sufficient to allow subsequent preparation of an identical customized patient medication package for the patient;
(5) the date of preparation of the customized patient medication package and the expiration date that was assigned;
(6) any special labeling instructions; and
(7) the name or initials of the pharmacist who prepared the customized patient medication package.
(16) Holding for sale, offering for sale and selling adulterated and/or misbranded drugs, devices and cosmetics. Any drug, device or cosmetic shall be deemed to be adulterated and/or misbranded if:
(i) it is not manufactured in accordance with the good manufacturing practices specified in parts 210 and 211 of title 21, Code of Federal Regulations (1984 edition, Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, Room 3035, Cultural Education Center, Albany, NY 12230), provided that a drug manufactured by a pharmacy for in-house use may be manufactured in accordance with protocols, including documentation by means of a batch record, which insure the meeting of established standards for purity and potency; and
(ii) at any time it fails to meet standards for purity, potency, labeling, safety and effectiveness established under the Federal Food, Drug and Cosmetic Act, as amended (June 1981, Superintendent of Public Documents, U.S. Government Printing Office, Washington, DC 20402, available at New York State Board of Pharmacy, Room 3035, Cultural Education Center, Albany, NY 12230).
(17) Holding for sale, offering for sale, or selling:
(i) any drug later than the date, if any, marked upon the label as indicative of the date beyond which the contents cannot be expected beyond reasonable doubt to be safe and effective and/or beyond use date, which shall mean the expiration date of the drug; provided, however, that when such drug is identified as an outdated drug by segregation from regular stock or by other means, the holding of such drug beyond its expiration date shall not be deemed a violation of this paragraph. When the expiration date is expressed by month and year, the expiration date shall be the last day of the month indicated; or
(ii) any drug, the nature of which requires storage under special conditions of temperature control as indicated either on the labeling, in the directions for storage of said drug contained in an official compendium, or as directed by common prudence, unless such special condition of temperature control shall have been complied with during the entire period of time in which such drug has been held for sale.
(18) The sale of drugs at auction without filing with the State Board of Pharmacy, at least seven days prior to the date of said auction, a notice giving the date, time and place of the auction. At such auction, drugs in bulk or in open containers may be sold in one lot only to a registered pharmacy. The drugs shall be removed to the premises of the purchaser promptly and the board notified as to the disposition of such drugs; provided, however, that drugs found, by the representative of the board assigned to such auction, to be unfit for human use by virtue of age, adulteration and/or misbranding shall be destroyed voluntarily in the presence of the said representative or shall be quarantined by the representative pending action for seizure and destruction.
(19) Holding for sale, offering for sale, selling or distributing a new drug or an investigational new drug, which is not recognized as a new drug or an investigational new drug under the provisions of part 310 or 312 of title 21, Code of Federal Regulations (1984 edition, Superintendent of Public Documents, U.S. Government Printing Office, Washington, DC 20402: 1984, available at New York State Board of Pharmacy, Room 3035, Cultural Education Center, Albany, NY 12230).
(20) Abandoning the premises of a registered establishment. Premises shall be deemed abandoned if the registrant vacates the premises without surrendering the certificate of registration to the State Board of Pharmacy and without making appropriate arrangements for the disposal of prescription-required drugs.
(21) Aiding and abetting an unlicensed person to dispense drugs.
(i) Subject to the limitations set forth in subparagraph (ii) of this paragraph, an unlicensed person may assist a pharmacist in the dispensing of drugs by:
(a) receiving written or electronically transmitted prescriptions, except that in the case of electronically transmitted prescriptions the pharmacists or pharmacy intern shall review the prescription to determine whether in his or her professional judgment it shall be accepted by the pharmacy, and if accepted, the pharmacist or pharmacy intern shall enter his or her initials into the records of the pharmacy;
(b) typing prescription labels;
(c) keying prescription data for entry into a computer-generated file or retrieving prescription data from the file, provided that such computer-generated file shall provide for verification of all information needed to fill the prescription by a pharmacist prior to the dispensing of the prescription, meaning that the pharmacist shall review and approve such information and enter his or her initials or other personal identifier into the recordkeeping system prior to the dispensing of the prescription or of the prescription refill;
(d) getting drugs from stock and returning them to stock;
(e) getting prescription files and other manual records from storage and locating prescriptions;
(f) counting dosage units of drugs;
(g) placing dosage units of drugs in appropriate containers;
(h) affixing the prescription label to the containers;
(i) preparing manual records of dispensing for the signature or initials of the pharmacist; and
(j) handing or delivering completed prescriptions to the patient or the person authorized to act on behalf of the patient and, in accordance with section 63.6(b)(8) of this Title advising the patient or person authorized to act on behalf of the patient of the availability of counseling to be conducted by the pharmacist or pharmacy intern.
(ii) Limitations on assistance by a registered pharmacy technician and an unlicensed person.
(a) No pharmacists, employed by a facility licensed in accordance with article 28 of the Public Health Law or a pharmacy owned and operated by such a facility, as defined in article 137-A of title VIII of the Education Law, shall obtain the assistance of more than two registered pharmacy technicians in the performance of licensed tasks within their scope of practice or four unlicensed persons in the performance of the activities that do not require licensure as set forth in clauses (i)(b)-(i) of this paragraph, the total number of such persons shall not exceed four individuals at one time. No pharmacist not employed by a facility licensed in accordance with article 28 of the Public Health Law or a pharmacy not owned and operated by such a facility, as defined in article 137-A of title VIII of the Education Law, shall obtain the assistance of more than four unlicensed persons in the performance of the activities set forth in clauses (i)(b)-(i) of this paragraph. Pharmacy interns shall be exempt from such ratios, but shall be supervised in accordance with this Part and Part 63 of this Title. The pharmacist shall provide the degree of supervision of such persons as may be appropriate to ensure compliance with the provisions of this Part and Part 63 of this Title. Individuals who are responsible for the act of placing drugs which are in unit-dose packaging into medication carts as part of an approved unit-dose drug distribution system for patients in institutional settings shall be exempt from such ratio, provided that such individuals are not also engaged in performing the activities set forth in clauses (i)(b)-(i) of this paragraph.
(b) Unlicensed persons shall not be authorized to:
(1) receive oral prescriptions from prescribers;
(2) interpret and evaluate a prescription for conformance with legal requirements, authenticity, accuracy and interaction of the prescribed drug with other known prescribed and over-the-counter drugs;
(3) make determinations of the therapeutic equivalency as such determinations apply to generic substitution or interchangeable biological product substitution;
(4) measure, weigh, compound or mix ingredients or engage in or assist in compounding;
(5) sign or initial any record of dispensing required to be maintained by law;
(6) counsel patients; or
(7) perform any other function involving the exercise of professional judgment.
(c) No drug which is dispensed with the assistance of an unlicensed person, as provided in subparagraph (i) of this paragraph, shall be dispensed without the review and approval of the pharmacist.
(b) Nothing in this Part shall be construed to prevent the ownership of a firm or corporate practice in this State by an unlicensed person or persons or to prevent any contractual arrangement computing the salary of professional employees or the amount due the owner of such firm or corporation or a person leasing space or equipment to such firm or corporation on the basis of a percentage of the receipts from the performance of professional services. This provision shall apply in lieu of section 29.1(b)(4) of this Part.
(c) The requirements of this section and sections 29.1 and 29.2 of this Part shall be applicable to nonresident establishments, as defined in section 6808-b of the Education Law, to the extent prescribed in section 63.8 of this Title.
8 CRR-NY 29.7
Current through May 15, 2021
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