                                 CODE OF VIRGINIA

DISPENSING OF INTERCHANGEABLE BIOSIMILARS PERMITTED (§ 54.1-3408.04)

A. A pharmacist may dispense a biosimilar that has been licensed by the U.S.
Food and Drug Administration as interchangeable with the prescribed product
unless (i) the prescriber indicates such substitute is not authorized by
specifying on the prescription &#8220;brand medically necessary&#8221; or (ii)
the patient insists on the dispensing of the prescribed biological product. In
the case of an oral prescription, the prescriber&#8217;s oral dispensing
instructions regarding dispensing of an interchangeable biosimilar shall be
followed. No pharmacist shall dispense a biosimilar in place of a prescribed
biological product unless the biosimilar has been licensed as interchangeable
with the prescribed biological product by the U.S. Food and Drug Administration.

B. When a pharmacist dispenses an interchangeable biosimilar in the place of a
prescribed biological product, the pharmacist or his designee shall inform the
patient prior to dispensing the interchangeable biosimilar. The pharmacist or
his designee shall also indicate, unless otherwise directed by the prescriber,
on both the record of dispensing and the prescription label, the brand name or,
in the case of an interchangeable biosimilar, the product name and the name of
the manufacturer or distributor of the interchangeable biosimilar. Whenever a
pharmacist substitutes an interchangeable biosimilar pursuant to a prescription
written for a brand-name product, the pharmacist or his designee shall label the
drug with the name of the interchangeable biosimilar followed by the words
&#8220;Substituted for&#8221; and the name of the biological product for which
the prescription was written. Records of substitutions of interchangeable
biosimilars shall be maintained by the pharmacist and the prescriber for a
period of not less than two years from the date of dispensing.

C. [Expired]

D. [Expired]

HISTORY: 2013, cc. 412, 544.