New York Codes, Rules and Regulations › Title 8 - EDUCATION DEPARTMENT › Chapter I - Rules of the Board Of Regents › Part 29 - Unprofessional Conduct › Section 29.7 - Special provisions for the professions of pharmacy and registered pharmacy technicians

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The
				requirements of this section set forth for written prescriptions shall also be
				applicable to electronic prescriptions, as de fined in section
				63.6(a)(7)(i)(a) 
				of this Title, unless otherwise indicate d. 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, sections 6816a(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).
(15)
(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 [two] 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 interchange
				able 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.