Bill Text: GA HB1124 | 2011-2012 | Regular Session | Introduced

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Bill Title: Pharmacists and pharmacies; prescription biologic product and biosimilar product; define

Spectrum: Partisan Bill (Republican 4-0)

Status: (Introduced - Dead) 2012-02-23 - House Second Readers [HB1124 Detail]

Download: Georgia-2011-HB1124-Introduced.html

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12 LC 33 4625

House Bill 1124

By: Representatives Jerguson of the 22nd, Cooper of the 41st, Watson of the 163rd, and Clark of the 98th

A BILL TO BE ENTITLED
AN ACT

To amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and pharmacies, so as to define prescription biologic product and prescription biosimilar product; to provide for substitutions; to provide for recording in the patient record; to provide for related matters; to repeal conflicting laws; and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

SECTION 1.

Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists and pharmacies, is amended by revising Code Section 26-4-5, relating to definitions, so as to add new paragraphs and to revise paragraph (40) to read as follows:

"(34.1) 'Prescription biologic product' means any drug that is approved by the United States Food and Drug Administration that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases.

(34.2) 'Prescription biosimilar product' means any drug product that has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biologic product for the specified indicated use."

"(40) 'Substitution' means to dispense pharmaceutically equivalent and therapeutically equivalent drug products or prescription biosimilar products as regulated by the board in place of the drug prescribed."

SECTION 2.

Said chapter is further amended by revising Code Section 26-4-81, relating to substitution of generic drugs for brand name drugs, so as to revise subsection (f) and to add a new subsection to read as follows:

"(f) A patient for whom a prescription drug order is intended may instruct a pharmacist not to substitute a generic name drug in lieu of a brand name drug and may also instruct a pharmacist not to substitute a prescription biosimilar product for a prescription biologic product. In the case of substitutions involving prescription biosimilar products for cancer or other life threatening conditions, the pharmacist shall notify the prescribing physician of the substitution within 24 hours."

"(h) If a practitioner of the healing arts prescribes a prescription biologic product, a pharmacist may substitute a prescription biosimilar product if such prescription biosimilar product has been listed by the board of pharmacy as interchangeable with such prescription biologic product. Such listing shall be included on the website of the board of pharmacy and available through other publicly accessible means."

SECTION 3.

Said chapter is further amended by revising Code Section 26-4-83, relating to patient record systems, so as to revise subsection (d) and to add a new subsection to read as follows:

"(d) Except as otherwise provided in subsection (e) of this Code section, a A patient record shall be maintained for a period of not less than two years from the date of the last entry in the profile record. This record may be a hard copy of a computerized form.

(e) The patient record shall also include a recording of any substitution of a prescription biologic product for a prescription biosimilar product for not less than five years. Such information shall be made available to the board of pharmacy without any patient identifying information as needed to address any public health and safety concerns."

SECTION 4.

All laws and parts of laws in conflict with this Act are repealed.