Chapter 357 further requires that, notwithstanding any other law, when an interchangeable biological product is unavailable and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. If the interchangeable biological product is not available and a medical emergency situation, which for purposes of Chapter 357 is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. In such instances the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions.

Chapter 357 also requires that the prescriber inform the patient whether he or she has prescribed a brand name or its generic equivalent drug product or interchangeable biological product.

Prior to Chapter 357, New York State law permitted and established requirements for the substitution by pharmacists of generic drugs from their branded counterparts, but did not allow for the substitution of biological products. Chapter 357 updated the law to reflect the growing market of biological products and allows for the substitution of an FDA designated interchangeable biological product by a pharmacist when not prohibited by the prescriber. By permitting the substitution of biological products, when the specified requirements for such substitutions are met, Chapter 357 furthers the public health by improving access to these products. Therefore, it is imperative that the requirements for these biological products substitutions be implemented as soon as possible.

The proposed amendment was presented to the Professional Practice Committee for recommendation and to the Full Board for adoption as an emergency action at the December 2017 meeting of the Board of Regents, effective December 12, 2017. Since the Board of Regents meets at fixed intervals, the earliest the proposed rule can be presented for adoption, after expiration of the required 60-day public comment period provided for in the State Administrative Procedure Act (SAPA) sections 201(1) and (5), would be the March 12-13, 2018 Regents meeting. Furthermore, pursuant to SAPA section 203(1), the earliest effective date of the proposed rule, if adopted at the March meeting, would be March 28, 2018, the date the Notice of Adoption would be published in the State Register. However, the December emergency rule will expire on March 11, 2018. If the rule were to lapse, it would impede the ability of pharmacists to substitute FDA designated biological products, when permissible under Chapter 357.

Therefore, emergency action is necessary at the February 2018 Regents meeting for the preservation of the public health and the general welfare in order to enable the State Education Department to continue to implement Chapter 357, which is already in effect, so that pharmacists will be able to substitute FDA designated biological products, unless prohibited from doing so by the prescriber.

It is anticipated that the proposed rule will be presented for permanent adoption as a permanent rule at the March 12-13, 2018 Regents meeting, which is the first scheduled meeting after expiration of the 60-day public comment period prescribed in the State Administrative Procedure Act for State agency rule makings.

(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) . . .

(2) . . .

(3) . . .

(4) . . .

(5) . . .

(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 6816-a(1)(c) and 6816-a(3)(c).

(7) . . .

(8) . . .

(i) . . .

(ii) . . .

(iii) . . .

(iv) . . .

(v) . . .

(a) . . .

(b) . . .

(vi) . . .

(vii) . . .

(9) . . .

(10) . . .

(11) . . .

(i) . . .

(ii) . . .

(iii) . . .

(iv) . . .

(12) . . .

(13) . . .

(14) . . .

(15) . . .

(i) . . .

(ii) . . .

(a) . . .

(b) . . .

(1) . . .

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(4) . . .

(5) . . .

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(c) . . .

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(g) . . .

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(5) . . .

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(7) . . .

(16) . . .

(i) . . .

(ii) . . .

(17) . . .

(i) . . .

(ii) . . .

(18) . . .

(19) . . .

(20) . . .

(21) Aiding and abetting an unlicensed person to dispense drugs.

(i) . . .

(a) . . .

(b) . . .

(c) . . .

(d) . . .

(e) . . .

(f) . . .

(g) . . .

(h) . . .

(i) . . .

(j) . . .

(ii) . . .

(a) . . .

(b) Unlicensed persons shall not be authorized to:

(1) . . .

(2) . . .

(3) make determinations of the therapeutic equivalency as such determinations apply to generic substitution or interchangeable biological product substitution;

(4) . . .

(5) . . .

(6) . . .

(7) . . .

(c) . . .

2. Paragraph (7) of subdivision (a) of section 63.6 of the Regulations of the Commissioner of Education is amended, as follows:

(a) General provisions.

(1) . . .

(2) . . .

(3) . . .

(4) . . .

(5) . . .

(6) . . .

(7) Electronic prescriptions.

(i) . . .

(a) . . .

(b) . . .

(c) . . .

(ii) A pharmacist may, based upon his or her professional judgment, accept an electronic prescription from a prescriber, to the pharmacy of the patient’s choice, subject to the following requirements:

(a) . . .

(b) . . .

(c) . . .

(d) . . .

(e) [such prescriptions shall be processed in accordance with the requirements of section 29.7 of this Title, provided, however, that prescriptions for controlled substances shall be filled in accordance with the requirements of article 33 of the Public Health Law; and] except when the prescriber inserts an electronic direction to dispense the drug as written, the prescriber’s electronic signature shall designate approval of an interchangeable biological product by a pharmacist. Notwithstanding any other provision of this section or any other law to the contrary, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. If the interchangeable biological product is not available and a medical emergency situation, which for purposes of this section is defined as any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated, exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. In such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions;

(f) [in accepting an electronic prescription, the pharmacist shall be subject to the applicable requirements of Part 29 of this Title relating to unprofessional conduct, including but not limited to section 29.1(b)(2) and (3) of this Title.] such prescriptions shall be processed in accordance with the requirements of section 29.7 of this Title, provided, however, that prescriptions for controlled substances shall be filled in accordance with the requirements of article 33 of the Public Health Law; and

(g) in accepting an electronic prescription, the pharmacist shall be subject to the applicable requirements of Part 29 of this Title relating to unprofessional conduct, including but not limited to section 29.1(b)(2) and (3) of this Title.

(iii) . . .

(8) . . .

(i) . . .

(a) . . .

(b) . . .

(c) . . .

(d) . . .

(e) . . .

(ii) . . .

(a) . . .

(b) . . .

(c) . . .

(iii) . . .

(iv) . . .

(v) . . .

(9) . . .

3. Clause (c) of subparagraph (ii) of paragraph (8) of subdivision (b) of section 63.6 of the Regulations of the Commissioner of Education is amended, as follows:

(b) Pharmacies.

(1) . . .

(i) . . .

(ii) . . .

(iii) . . .

(iv) . . .

(2) . . .

(3) . . .

(4) . . .

(5) . . .

(6) . . .

(i) . . .

(a) . . .

(b) . . .

(1) . . .

(2) . . .

(ii) . . .

(a) . . .

(b) . . .

(c) . . .

(d) . . .

(e) . . .

(f) . . .

(g) . . .

(iii) . . .

(7) . . .

(8) Counseling.

(i) . . .

(a) . . .

(1) . . .

(2) . . .

(3) . . .

(4) . . .

(5) . . .

(6) . . .

(7) . . .

(8) . . .

(b) . . .

(c) . . .

(d) . . .

(e) . . .

(ii) Off-premises delivery. For a prescription that is delivered to the patient or the person authorized to act on behalf of the patient off the premises of the pharmacy through mail delivery, a delivery service or otherwise, the pharmacist or pharmacy intern shall meet the requirements of this subparagraph.

(a) . . .

(b) . . .

(c) Except for instances covered by clause (d) of this subparagraph, which applies in those cases, if upon presentation of the prescription, the pharmacist or pharmacy intern determines that the prescription is a prescriber approved alternative drug, meaning a change in the drug originally prescribed exclusive of generic substitutions or interchangeable biological product substitutions, the pharmacist or pharmacy intern shall meet the following requirements in addition to the requirements of clauses (a) and (b) of this subparagraph:

(1) …

(2) …

(3) …

(4) …

(5) …

(6) …

(7) …

(d) . . .

(1) . . .

(2) . . .

(3) . . .

(4) . . .

(5) . . .

(9) . . .

1. STATUTORY AUTHORITY:

Section 207 of the Education Law grants general rulemaking authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.

Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.

Paragraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner of Education to promulgate regulations in administering the admission to and the practice of the professions.

Subdivision (9) of section 6509 of the Education Law authorizes the Board of Regents to define unprofessional conduct in the professions.

Section 6802 of the Education Law, as amended by Chapter 357 of the Laws of 2017, defines the terms “biological product” and “interchangeable biological product.”

Section 6810 of the Education Law, as amended by Chapter 357 of the Laws of 2017, establishes the conditions under which the substitution of a biological product is required and requires the prescriber to inform the patient as to whether he or she has prescribed a brand name or interchangeable biological product.

Section 6816-a of the Education Law, as amended by Chapter 357 of the Laws of 2017, establishes the conditions under which the substitution of a biological product is required and the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed.

2. LEGISLATIVE OBJECTIVES:

The proposed amendment carries out the intent of the aforementioned statutes that the Department shall supervise the regulation of the practice of the professions for the benefit of the public. The proposed amendment will conform the Rules of the Board of Regents and the Regulations of the Commissioner of Education to Chapter 357 of the Laws of 2017 (Chapter 357), which amended the Education Law by adding definitions for the terms “biological product” and “interchangeable biological product”, effective October 23, 2017. Chapter 357 also amended the Education Law to set forth the conditions under which the substitution of a biological product is required and established the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed.

Biological products are regulated by the United States Food and Drug Administration (FDA) and are used to diagnose, prevent, treat and cure diseases. Biological products are generally large complex molecules, produced through biotechnology in living systems such as a microorganism from plant or animal cells, making them more difficult to characterize than small molecule drugs. Currently, there are over 200 biological products approved by the FDA for use, including monoclonal antibodies, vaccines, and proteins. Biological products are used to treat patients with complex chronic disease and/or critically ill patients, including, but not limited to, cancer, heart disease, arthritis, multiple sclerosis, and HIV/AIDS.

Single biological products, already approved by FDA, are called reference products which are the products against which a proposed biosimilar product is compared. Products designated by the FDA as biosimilar are highly similar to, and have no clinically meaningful differences from, an existing FDA-approved reference product. Biosimilar products are specifically prescribed by a practitioner and should not be substituted for a reference product.

A biosimilar product may be designated by the FDA as an interchangeable biological if it is biosimilar to the reference product, and has proven that it can be expected to produce the same clinical result as the reference product in any given patient. In addition, to be determined to be an interchangeable biological product, it must be shown that for a biological product that is administered more than once to an individual, the risk, in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product, is not greater than the risk of using the reference product without such alternation or switch. An interchangeable product may be substituted for the reference product without the involvement of the prescriber.

Prior to Chapter 357, New York State law permitted and established requirements for the substitution by pharmacists of generic drugs from their branded counterparts, but did not allow for the substitution of biological products. Chapter 357 updated the law to reflect the growing market of biological products and allows for the substitution of an FDA designated interchangeable biological product by a pharmacist when not prohibited by the prescriber.

The proposed amendment of subdivision (a) of section 29.7 of the Rules of the Board of Regents adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. The proposed amendment also prohibits unlicensed persons from making determinations of the therapeutic equivalency as such determinations apply to interchangeable biological product substitution.

The proposed amendment of paragraph (7) of subdivision (a) of section 63.6 of the Regulations of the Commissioner of Education provides that a pharmacist may, based upon his or her professional judgment, accept an electronic prescription from a prescriber, to the pharmacy of the patient’s choice except when the prescriber inserts an electronic direction to dispense the drug as written, otherwise, the prescriber’s electronic signature shall designate approval of substitution by a pharmacist of an interchangeable biological product. The proposed amendment further provides that notwithstanding any other provision of section 63.6 or any other law to the contrary, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. In addition, the proposed amendment provides that if the interchangeable biological product is not available and a medical emergency exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. The proposed amendment also requires that, in such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions.

The proposed amendment of clause (c) of subparagraph (ii) of paragraph (8) of subdivision (b) of section 63.6 of the Regulations of the Commissioner of Education includes substitutions of interchangeable biological products along with generic substitutions in the off-premise counseling requirements. The proposed amendment clarifies that permitted substitution of an interchangeable biological product is not a change in prescribed therapy and does not require the additional patient notifications and counseling that result from a prescriber approved alternative therapy.

3. NEEDS AND BENEFITS:

The proposed amendment is necessary to conform the Rules of the Board of Regents and the Regulations of the Commissioner of Education to Chapter 357. The proposed amendment defines the terms “biological product” and “interchangeable biological product.” The proposed amendment also sets forth the conditions under which the substitution of a biological product is required and establishes the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed.

Additionally, the proposed amendment adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. The proposed amendment also prohibits unlicensed persons from making determinations of the therapeutic equivalency as such determinations apply to interchangeable biological product substitution.

4. COSTS:

The proposed amendment imposes no additional costs on the State or local governments or the regulatory agency.

(a) Costs to State government. There are no additional costs to State government.

(b) Costs to local government. There are no additional costs to local government.

(c) Costs to private regulated parties. There are no additional costs to private regulated parties.

(d) Costs to the regulatory agency. There are no additional costs to the State Education Department.

5. LOCAL GOVERNMENT MANDATES:

The proposed amendment does not impose any program, service, duty, or responsibility on local governments.

6. PAPERWORK:

The proposed amendment of subdivision (a) of section 29.7 of the Rules of the Board of Regents adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. This is already the standard for a generic product dispensed on a prescription. Thus, the Department does not anticipate that regulated parties will encounter any challenges with complying with this proposed requirement with respect to an interchangeable biological product dispensed on a prescription.

The proposed amendment of paragraph (7) of subdivision (a) of section 63.6 of the Regulations of the Commissioner of Education provides that a pharmacist may, based upon his or her professional judgment, accept an electronic prescription from a prescriber, to the pharmacy of the patient’s choice except when the prescriber inserts an electronic direction to dispense the drug as written, otherwise, the prescriber’s electronic signature shall designate approval of substitution by a pharmacist of an interchangeable biological product. The proposed amendment further provides that notwithstanding any other provision of section 63.6 or any other law to the contrary, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. In addition, the proposed amendment provides that if the interchangeable biological product is not available and a medical emergency exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. The proposed amendment also requires that, in such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions. This process is the standard used when a brand name medication is dispensed due to generic medication unavailability or if a medical emergency exists. The Department does not anticipate that regulated parties will encounter any challenges with complying with this proposed requirement with respect to an interchangeable biological product.

7. DUPLICATION:

The proposed amendment does not duplicate any other existing State or federal requirements and is necessary to implement Chapter 357.

8. ALTERNATIVES:

The proposed amendment is necessary to implement Chapter 357, which amended the Education Law by adding definitions for the terms “biological product” and “interchangeable biological product”, setting forth the conditions under which the substitution of a biological product is required and establishing the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed. There are no significant alternatives to the proposed amendment and none were considered.

9. FEDERAL STANDARDS:

The proposed amendment conforms the definition for biological and interchangeable biological product with federal standards outlined in the Biologics Price Competition and Innovation Act of 2009 which amended the Public Health Services Act. The proposed amendment does not exceed any minimum federal standards for the same or similar subject areas.

10. COMPLIANCE SCHEDULE:

The proposed amendment is necessary to conform the Rules of the Board of Regents and the Regulations of the Commissioner of Education to Chapter 357. It is anticipated that the regulated parties will be able to comply with the proposed amendments by the effective date.

The purpose of the proposed amendment is to implement Chapter 357 of the Laws of 2017 (Chapter 357), which amended the Education Law by adding definitions for the terms “biological product” and “interchangeable biological product”, effective October 23, 2017. Chapter 357 also amended the Education Law to set forth the conditions under which the substitution of a biological product is required and established the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed.

Biological products are regulated by the United States Food and Drug Administration (FDA) and are used to diagnose, prevent, treat and cure diseases. Biological products are generally large complex molecules, produced through biotechnology in living systems such as a microorganism from plant or animal cells, making them more difficult to characterize than small molecule drugs. Currently, there are over 200 biological products approved by the FDA for use, including monoclonal antibodies, vaccines, and proteins. Biological products are used to treat patients with complex chronic disease and/or critically ill patients, including, but not limited to, cancer, heart disease, arthritis, multiple sclerosis, and HIV/AIDS.

Single biological products, already approved by FDA, are called reference products which are the products against which a proposed biosimilar product is compared. Products designated by the FDA as biosimilar are highly similar to, and have no clinically meaningful differences from, an existing FDA-approved reference product. Biosimilar products are specifically prescribed by a practitioner and should not be substituted for a reference product.

A biosimilar product may be designated by the FDA as an interchangeable biological if it is biosimilar to the reference product, and has proven that it can be expected to produce the same clinical result as the reference product in any given patient. In addition, to be determined to be an interchangeable biological product, it must be shown that for a biological product that is administered more than once to an individual, the risk, in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product, is not greater than the risk of using the reference product without such alternation or switch. An interchangeable product may be substituted for the reference product without the involvement of the prescriber.

Prior to Chapter 357, New York State law permitted and established requirements for the substitution by pharmacists of generic drugs from their branded counterparts, but did not allow for the substitution of biological products. Chapter 357 updated the law to reflect the growing market of biological products and allows for the substitution of an FDA designated interchangeable biological product by a pharmacist when not prohibited by the prescriber.

The proposed amendment of subdivision (a) of section 29.7 of the Rules of the Board of Regents adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. The proposed amendment also prohibits unlicensed persons from making determinations of the therapeutic equivalency as such determinations apply to interchangeable biological product substitution.

The proposed amendment of paragraph (7) of subdivision (a) of section 63.6 of the Regulations of the Commissioner of Education provides that a pharmacist may, based upon his or her professional judgment, accept an electronic prescription from a prescriber, to the pharmacy of the patient’s choice except when the prescriber inserts an electronic direction to dispense the drug as written, otherwise, the prescriber’s electronic signature shall designate approval of substitution by a pharmacist of an interchangeable biological product. The proposed amendment further provides that notwithstanding any other provision of section 63.6 or any other law to the contrary, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. In addition, the proposed amendment provides that if the interchangeable biological product is not available and a medical emergency exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. The proposed amendment also requires that, in such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions.

The proposed amendment of clause (c) of subparagraph (ii) of paragraph (8) of subdivision (b) of section 63.6 of the Regulations of the Commissioner of Education includes substitutions of interchangeable biological products along with generic substitutions in the off-premise counseling requirements. The proposed amendment clarifies that permitted substitution of an interchangeable biological product is not a change in prescribed therapy and does not require the additional patient notifications and counseling that result from a prescriber approved alternative therapy.

The proposed amendment does not impose any additional costs on regulated parties beyond those required by statute. The proposed amendment adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. This is already the standard for a generic product dispensed on a prescription. Thus, the Department does not anticipate that regulated parties will encounter any challenges with complying with this proposed requirement with respect to an interchangeable biological product dispensed on a prescription.

The proposed amendment also provides that a pharmacist may, based upon his or her professional judgment, accept an electronic prescription from a prescriber, to the pharmacy of the patient’s choice except when the prescriber inserts an electronic direction to dispense the drug as written, otherwise, the prescriber’s electronic signature shall designate approval of substitution by a pharmacist of an interchangeable biological product. The proposed amendment further provides that notwithstanding any other provision of section 63.6 or any other law to the contrary, when an interchangeable biological product is not available and the biological product originally prescribed is available and the pharmacist agrees to dispense the prescribed biological product for a price that will not exceed the price that would have been charged for the interchangeable biological substitute had it been available, substitution of an interchangeable biological product will not be required. In addition, the proposed amendment provides that if the interchangeable biological product is not available and a medical emergency exists, then the pharmacist may dispense the prescribed biological product at his or her regular price. The proposed amendment also requires that, in such instances, the pharmacist must record the date, hour and nature of the medical emergency on the back of the prescription and keep a copy of all such prescriptions. This process is the standard used when a brand name medication is dispensed due to generic medication unavailability or if a medical emergency exists. The Department does not anticipate that regulated parties will encounter any challenges with complying with this proposed requirement with respect to an interchangeable biological product. The Department anticipates that the potential costs for complying with these proposed amendment’s requirements will be minimal.

The proposed amendment does not impose any new reporting, recordkeeping, or other compliance requirements on local governments or have any adverse economic impact on small businesses or local governments. Because it is evident from the nature of the proposed amendment that it will not adversely affect small businesses or local governments, no affirmative steps were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses and local governments is not required, and one has not been prepared.

The proposed rule is necessary to implement Chapter 357 of the Laws of 2017 (“Chapter 357”), which amended the Education Law to define the terms “biological product” and “interchangeable biological product”, set forth the conditions under which the substitution of a biological product is required, and establish the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed, effective October 23, 2017. Additionally, the proposed amendment adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. The proposed amendment also prohibits unlicensed persons from making determinations of the therapeutic equivalency as such determinations apply to interchangeable biological product substitution.

Chapter 357 does not provide any exceptions from these requirements for any pharmacists, pharmacies or prescribers located in rural areas. Thus, the proposed amendment does not adversely impact entities in rural areas of New York State because all New York State pharmacists, pharmacies and prescribers must comply with the same interchangeable biological product substitution requirements. Accordingly, no further steps were needed to ascertain the impact of the proposed amendment on entities in rural areas and none were taken. Thus, a rural flexibility analysis is not required and one has not been prepared.

The proposed amendment implements Chapter 357 of the Laws of 2017 by defining the terms “biological product” and “interchangeable biological product”, setting forth the conditions under which the substitution of a biological product is required and establishing the appropriate method of communication by the pharmacist to the prescriber notifying the prescriber of the substitution of the biological product dispensed. Additionally, the proposed amendment adds the failure to identify an 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(3)(c), to the unprofessional conduct special provisions for the profession of pharmacy. The proposed amendment also prohibits unlicensed persons from making determinations of the therapeutic equivalency as such determinations apply to interchangeable biological product substitution.

The proposed amendment will not have a substantial adverse impact on jobs and employment opportunities. Because it is evident from the nature of the proposed amendment that it will not affect job and employment opportunities, no affirmative steps were needed to ascertain these facts and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.