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A BILL TO BE ENTITLED
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AN ACT
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relating to the prescription and pharmaceutical substitution of |
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biological products. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 562, Occupations Code, is amended by |
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adding Subchapter F to read as follows: |
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SUBCHAPTER F. PRESCRIPTION AND SUBSTITUTION REQUIREMENTS FOR |
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BIOLOGICAL PRODUCTS |
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Sec. 562.251. DEFINITIONS. In this subchapter, "biological |
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product," "biosimilar," "interchangeable," and "reference product" |
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have the meanings assigned by Section 351, Public Health Service |
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Act (42 U.S.C. Section 262). |
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Sec. 562.252. PRESCRIPTION TRANSMITTED ORALLY BY |
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PRACTITIONER. A pharmacist to whom a prescription for a biological |
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product is transmitted orally shall: |
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(1) note on the file copy of the prescription the |
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dispensing instructions of the practitioner or the practitioner's |
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agent; and |
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(2) retain the prescription for the period specified |
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by law for pharmacy records. |
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Sec. 562.253. RECORD OF DISPENSED BIOLOGICAL PRODUCT. (a) |
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A pharmacist shall record on the prescription form the name, |
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strength, and manufacturer or distributor of a biological product |
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dispensed as authorized by this subchapter. |
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(b) A record established under this subchapter is subject to |
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the recordkeeping requirements applicable to pharmacy records. |
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Sec. 562.254. LABEL. (a) Unless otherwise directed by the |
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practitioner, the label on the dispensing container must indicate |
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the actual biological product dispensed by: |
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(1) the brand name; or |
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(2) if there is not a brand name, the actual name of |
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the biological product, the strength of the biological product, and |
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the name of the manufacturer or distributor of the biological |
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product. |
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(b) In addition to the information required by Subsection |
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(a), the label on the dispensing container of a biological product |
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dispensed by a Class A, Class C, Class D, or Class E pharmacy must |
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indicate: |
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(1) the name, address, and telephone number of the |
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pharmacy; |
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(2) the date the prescription is dispensed; |
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(3) the name of the prescribing practitioner; |
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(4) the name of the patient or, if the biological |
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product was prescribed for an animal, the species of the animal and |
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the name of the owner; |
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(5) instructions for use; |
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(6) the quantity dispensed; |
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(7) if the biological product is dispensed in a |
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container other than the manufacturer's original container, the |
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date after which the prescription should not be used, determined |
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according to criteria established by the United States Food and |
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Drug Administration; and |
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(8) any other information required by board rule. |
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(c) The information required by Subsection (b)(7) may be |
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recorded on any label affixed to the dispensing container. |
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(d) If a biological product has been selected other than the |
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one prescribed, the pharmacist shall place on the container the |
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words "Substituted for brand prescribed" or "Substituted for 'brand |
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name'" where "brand name" is the name of the brand name biological |
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product prescribed. |
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(e) The board shall adopt rules requiring the label on a |
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dispensing container to be in plain language and printed in an |
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easily readable font size for the consumer. |
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Sec. 562.255. OTHER PRESCRIPTION INFORMATION. The board |
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shall adopt rules specifying the information a pharmacist must |
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provide to a consumer when dispensing a prescription for a |
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biological product to the consumer for self-administration. The |
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information must be: |
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(1) written in plain language; |
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(2) relevant to the prescription; and |
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(3) printed in an easily readable font size. |
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Sec. 562.256. REFILLS. Except as provided by Section |
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562.0545, a properly authorized prescription refill must follow the |
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original dispensing instruction unless otherwise indicated by the |
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practitioner or the practitioner's agent. |
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Sec. 562.257. INTERCHANGEABLE BIOSIMILAR BIOLOGICAL |
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PRODUCT AUTHORIZED. (a) A pharmacy may not substitute a biosimilar |
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biological product for a prescribed reference product unless the |
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United States Food and Drug Administration has determined that the |
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biosimilar biological product is interchangeable with the |
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prescribed reference product for the specified indicated use. |
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(b) If a practitioner certifies on the prescription form |
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that a specific prescribed reference product is medically |
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necessary, the pharmacist shall dispense the reference product as |
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written by the practitioner. The certification must be made as |
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required by the dispensing directive adopted under Section 562.263. |
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(c) Except as otherwise provided by this subchapter, a |
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pharmacist who receives a prescription for a reference product for |
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which there is one or more interchangeable biosimilar biological |
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products may dispense any of the interchangeable biosimilar |
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biological products for the specified indicated use. |
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Sec. 562.258. REQUIREMENTS CONCERNING SELECTION OF |
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INTERCHANGEABLE BIOSIMILAR. (a) Before delivery of a prescription |
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for an interchangeable biosimilar biological product, a pharmacist |
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must personally, or through the pharmacist's agent or employee: |
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(1) inform the patient or the patient's agent that a |
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less expensive interchangeable biosimilar biological product is |
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available for the reference product prescribed; and |
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(2) ask the patient or the patient's agent to choose |
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between the interchangeable biosimilar biological product and the |
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reference product prescribed. |
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(b) A pharmacy is not required to comply with the provisions |
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of Subsection (a): |
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(1) in the case of the refill of a prescription for |
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which the pharmacy previously complied with Subsection (a) with |
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respect to the same patient or patient's agent; or |
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(2) if the patient's physician or physician's agent |
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advises the pharmacy that: |
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(A) the physician has informed the patient or the |
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patient's agent that a less expensive interchangeable biosimilar |
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biological product is available for the reference product |
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prescribed; and |
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(B) the patient or the patient's agent has chosen |
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either the reference product prescribed or the less expensive |
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interchangeable biosimilar biological product. |
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(c) A pharmacy that supplies a prescription by mail is |
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considered to have complied with the provisions of Subsection (a) |
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if the pharmacy includes on the prescription order form completed |
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by the patient or the patient's agent language that clearly and |
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conspicuously: |
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(1) states that if a less expensive interchangeable |
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biosimilar biological product is available for the reference |
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product prescribed, the patient or the patient's agent may choose |
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between the interchangeable biosimilar biological product and the |
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reference product prescribed; and |
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(2) allows the patient or the patient's agent to |
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indicate the choice of the interchangeable biosimilar biological |
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product or the reference product prescribed. |
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(d) If the patient or the patient's agent fails to indicate |
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otherwise to a pharmacy on the prescription order form under |
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Subsection (c), the pharmacy may dispense an interchangeable |
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biosimilar biological product. |
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Sec. 562.259. DISCLOSURE OF PRICE; PATIENT'S OPTION. If |
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the price of an interchangeable biosimilar biological product to a |
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patient is lower than the amount of the patient's copayment under |
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the patient's prescription drug insurance plan, the pharmacist |
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shall offer the patient the option of paying for the biosimilar |
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biological product at the lower price instead of paying the amount |
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of the copayment. |
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Sec. 562.260. NOTIFICATION OF SUBSTITUTION. (a) If a |
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pharmacist dispenses an interchangeable biosimilar biological |
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product to a patient, the pharmacist shall notify the prescribing |
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practitioner. |
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(b) The notification required under Subsection (a) must: |
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(1) be transmitted in writing or electronically; |
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(2) identify the name, strength, and manufacturer or |
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distributor of the biological product dispensed to the patient; and |
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(3) be transmitted to the prescribing practitioner not |
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later than the third day after the date the biological product is |
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dispensed. |
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Sec. 562.261. RESPONSIBILITY CONCERNING BIOSIMILAR |
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BIOLOGICAL PRODUCTS; LIABILITY. (a) A pharmacist who selects an |
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interchangeable biosimilar biological product to be dispensed |
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under this subchapter assumes the same responsibility for selecting |
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the biosimilar biological product as the pharmacist does in filling |
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a prescription for a reference product. |
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(b) The prescribing practitioner is not liable for a |
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pharmacist's act or omission in selecting, preparing, or dispensing |
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a biological product under this subchapter. |
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Sec. 562.262. RESTRICTION ON SELECTION OF AND CHARGING FOR |
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BIOSIMILAR BIOLOGICAL PRODUCTS. (a) A pharmacist may not select an |
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interchangeable biosimilar biological product unless the |
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interchangeable product selected costs the patient less than the |
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prescribed reference product. |
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(b) A pharmacist may not charge for dispensing an |
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interchangeable biosimilar biological product a professional fee |
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higher than the fee the pharmacist customarily charges for |
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dispensing the reference product prescribed. |
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Sec. 562.263. DISPENSING DIRECTIVE; COMPLIANCE WITH |
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FEDERAL LAW. The board shall adopt rules to provide a dispensing |
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directive to instruct pharmacists on the manner in which to |
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dispense a biological product according to the contents of a |
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prescription. The rules adopted under this section must: |
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(1) require the use of the phrase "brand necessary" or |
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"brand medically necessary" on a prescription form to prohibit the |
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substitution of an interchangeable biosimilar biological product |
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for a reference product; |
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(2) be in a format that protects confidentiality as |
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required by the Health Insurance Portability and Accountability Act |
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of 1996 (29 U.S.C. Section 1181 et seq.); and |
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(3) comply with federal and state law, including |
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rules, with regard to formatting and security requirements. |
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SECTION 2. The Texas State Board of Pharmacy shall adopt |
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rules necessary to implement Subchapter F, Chapter 562, Occupations |
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Code, as added by this Act, not later than January 1, 2014. |
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SECTION 3. (a) Except as provided by Subsection (b) of this |
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section, this Act takes effect September 1, 2013. |
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(b) Subchapter F, Chapter 562, Occupations Code, as added by |
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this Act, takes effect January 1, 2014. |