P.R. Laws tit. 20, § 410b
(a) Drugs that may be interchanged.— The interchange of a prescribed medication for a bioequivalent medication shall be allowed in Puerto Rico when the therapeutic equivalence of the latter has been recognized by the U.S. Food and Drug Administration (FDA), and the same is codified as such in the Approved Drug Products with Therapeutic Equivalence Evaluations, better known as the Orange Book.
(b) Pharmacist’s authority to interchange bioequivalent medications.— The pharmacist may interchange bioequivalent medications in the manner stated below:
(1) When a medication is prescribed under a brand name or trademark, it shall be construed that any medication which is bioequivalent to the latter has been prescribed, unless the prescribing professional writes down in his/her own handwriting the phrase “Do not interchange” or indicates in the electronically generated and transmitted prescription that he/she does not authorize such interchange. The pharmacist shall advise the patient or his/her authorized representative of the possibility of interchanging the prescribed medication; Provided, That in all cases the patient or his/her representative must be over the age of eighteen (18). If the patient or his/her representative agrees to the interchange, the pharmacist shall choose that bioequivalent medication which meets each and every one of the following conditions:
(A) The same is included in the Orange Book under a codification starting with the letter “A”.
(B) The same costs less than the prescribed medication. In the event the prescribed medication or another at a lesser price is not available, an equally priced medication may be dispensed, if the patient or his/her representative agrees.
(C) The patient or his/her representative has given his/her consent to interchanging. The patient’s consent shall be documented with his/her signature on the back of the prescription, except in the case of an electronically generated and transmitted prescription, which shall be documented in the patient’s pharmacy record.
(2) If the patient requests to interchange the prescribed brand name medication despite the fact that the prescribing professional has written down in his/her own handwriting the phrase “Do Not Interchange,” the pharmacist shall obtain the authorization of the prescribing professional before interchanging the medication and record in the patient’s pharmacy record or on the back of the prescription that date and time in which he/she obtained such an authorization.
(3) When a medication is prescribed under its generic name, the pharmacist shall choose the generic medication or the brand name product available which costs the [least].
(4) When interchanging the medication, the pharmacist shall record in the patient’s pharmacy record or on the back of the prescription the date on which the medication is interchanged and he/she shall sign the prescription. Provided, That in the event that the prescription is electronically generated and transmitted, the device that receives and processes the same shall authenticate the identity of the pharmacist assuming responsibility for such medication dispensation. Furthermore, the pharmacist shall also record on the back of the prescription or on the patient’s pharmacy record, the brand name or trademark of the medication thus dispensed. Should the medication have no brand name or trademark, he/she shall record the generic name and the name of the manufacturer or distributor that appears on the medication’s label.
(5) The pharmacist shall label the product thus dispensed with the brand name or trademark in the event he/she has dispensed a brand name product, or with the generic name and the name of the manufacturer, in the event he/she has dispensed a generic product. In the event that the pharmacist interchanges the prescribed medication for another one, pursuant to this section, the labeling of the dispensed product shall include the names of both medications together with the phrase “bioequivalent to” or a similar language indicating that the prescribed medication was interchanged, except when the prescribing professional indicates otherwise in writing.
(6) When interchanging a prescribed brand name medication for a bioequivalent medication pursuant to the provisions set forth in this section, the pharmacist shall not incur any liability other than that which he/she may incur if he/she dispenses the prescribed brand name medication.
(c) List of most frequently used bioequivalent medications.— Pharmacies shall post in a visible place accessible to consumers, a list of at least twenty-five (25) most frequently used medications with their bioequivalent medications and their prices.
(d) In any pharmacy coverage under a health services plan, all the provisions of this chapter concerning the interchange for bioequivalent medications shall apply.
History —Sept. 3, 2004, No. 247, § 5.03; Nov. 16, 2009, No. 138, § 3; June 5, 2011, No. 85, § 2.