(a) When a pharmacist receives a prescription drug order from a practitioner for a brand or trade name drug, the pharmacist may dispense a therapeutically equivalent drug if the following conditions are met:

(1) The practitioner, in the case of a written prescription, places that practitioner’s own signature on the signature line alongside or above the words “substitution permitted” pursuant to subsection (c) of this section; or, in the case of a verbal prescription or a verbal prescription reduced to writing, the practitioner states that the substitution may be made; or, in the case of an order written in an institution licensed by the Department of Health and Social Services pursuant to Chapter 10 or Chapter 11 of Title 16, the practitioner has given written authorization to fill all prescription drug orders with therapeutically equivalent drugs unless otherwise indicated.

(2) The pharmacist informs the patient or the patient’s adult representative that a therapeutically equivalent drug has been dispensed.

(3) The pharmacist indicates on the prescription and on the prescription label the name of the manufacturer or distributor of the therapeutically equivalent drug substituted unless the practitioner indicates otherwise.

(b) Unauthorized dispensing of a therapeutically equivalent drug in violation of this section is punishable by a fine of not less than $500 nor more than $1,000 or by a term of imprisonment of not less than 30 days nor more than 1 year, or both a fine and a term of imprisonment.

(c) Every prescription in this State that is reduced to writing must be on a prescription form containing a line for the practitioner’s signature. Alongside or beneath the signature line, the words “Substitution Permitted” must be clearly printed. Beneath the signature line the following statement must be clearly printed:

“In order for a brand name product to be dispensed, the prescriber must handwrite ‘Brand Necessary’ or ‘Brand Medically Necessary’ in the space below.”

A second line to accommodate such wording must be provided beneath the statement. Prescription forms containing the appropriate signature line and statement must be used by every practitioner in this State who prescribes drugs.

24 Del. C. 1953, §  2589;  53 Del. Laws, c. 90, §  33;  60 Del. Laws, c. 330, §§  1-3;  62 Del. Laws, c. 161, §  1;  63 Del. Laws, c. 48, §§  1, 2;  65 Del. Laws, c. 378, §  5;  68 Del. Laws, c. 206, §  1;  70 Del. Laws, c. 149, §  216;  70 Del. Laws, c. 186, §  1;  73 Del. Laws, c. 311, §  1;  76 Del. Laws, c. 167, §  1;  85 Del. Laws, c. 49, § 1; 

(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 § 2550 of this title.

(2) The product to be substituted has been designated by the Food and Drug Administration (FDA) 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.

(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 dispensed, by 1 of the following:

(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.

(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 must maintain a record of the biological product dispensed as required in § 2532 of this title.

(d) The Board shall maintain a link on its website to the current list of all biological products determined by the U.S. Food and Drug Administration to be interchangeable with a specific biological product.

(e) Hospital pharmacies are exempt from the requirements of subsection (b) of this section.

79 Del. Laws, c. 238, §  1;  85 Del. Laws, c. 49, § 1; 

A pharmacist may dispense an emergency supply of a noncontrolled drug to a patient pursuant to the requirements set forth in the Board’s rules and regulations.

68 Del. Laws, c. 206, §  1;  70 Del. Laws, c. 186, §  1;  76 Del. Laws, c. 167, §  1;  85 Del. Laws, c. 49, § 1;