(a) A pharmacist may substitute for a prescribed biological product only if:
(1) The practitioner has not expressly prohibited substitution in a manner specified in § 2549 of this title;
(2) The product to be substituted has been designated by the Federal Food and Drug Administration as interchangeable with or therapeutically equivalent to the prescribed product;
(3) The pharmacist informs the patient or the patient’s adult representative that an interchangeable biological product has been dispensed; and
(4) The pharmacist indicates on the prescription and on the prescription label the name of the manufacturer of the interchangeable biological product substituted unless the practitioner indicates otherwise.
(b) If a biological product is dispensed, the pharmacist or the pharmacist’s designee shall, within a reasonable time but not to exceed 10 days following dispensing, communicate to the practitioner the name and manufacturer of the biological product dispensed, by:
(1) Recording such information in an interoperable electronic health records system shared with the prescribing practitioner, to the extent such a system is in place between a pharmacist and practitioner; or
(2) In the case where electronic health records are not in place between a pharmacist and a practitioner, communicating such information to the practitioner using any prevailing means available. No communication is required under this subsection where there is no interchangeable or therapeutically equivalent biological product for the prescribed biological product, or where a refill prescription is not changed from the biological product originally dispensed.
(c) The pharmacy shall maintain a record of the biological product dispensed as required in § 2532 of this title.
(d) The Board of Pharmacy shall maintain a link on its web site to the current list of all biological products determined by the Federal Food and Drug Administration to be interchangeable with a specific biological product.
(e) Hospital pharmacies shall be exempt from the requirements of subsection (b) of this section.
79 Del. Laws, c. 238, § 1.
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