Bioidentical Hormones - U.S. Senate Special Committee on Aging

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This report addresses the state laws and regulations related to the five protections
set forth above. 2 As described more fully below, these laws and regulations do not
provide the protections offered to patients under the current or proposed provisions of the
FDCA.
FINDINGS
1. Disclosure that a Product Is Compounded
* Only six states require that a pharmacy disclose to the patient that the drug being
dispensed is a compounded drug.
In Arizona, pharmacists must include on the label: "a statement, symbol, designation, or
abbreviation that the pharmaceutical product is a compounded pharmaceutical product."
Ariz. Admin. Code § R4-23-410(l)(4) (2007). In Colorado, the pharmacist must include
the following statement on the label of all compounded drugs: "This product was
compounded by the pharmacy." 3 Colo. Code Regs. § 719- 1 (2007). In Iowa, when a
compounded product is to be dispensed in place of a commercially available product, the
pharmacist must inform both the prescriber and the patient that the product will be
compounded. See Iowa Admin. Code r. 657-20.3(1) (2007). In Oklahoma, the
pharmacist must include on the label "an appropriate designation that this is a
compounded prescription." Okla. Admin. Code § 535:16-10-9 (2007). In Alaska, the
patient must be made aware that the compounded product will be prepared by the
pharmacist. Alaska Division of Corporations, Business and Professional Licensing,
Pharmacy Statutes and Regulations, at Appendix C (2007). In Washington, a
entrnoumded {Lg con, be substiuted for a cor -crcially available duuig Oity witl dilc
written authorization of both the patient and the prescriber. Wash. Admin. Code § 246-
878-020(1).
2. Active Ingredients Used in Compounded Drugs
* The vast majority of states do not address the quality or types of active ingredients
compounding pharmacists may use.
* Of the fiteen states that address the issue, eleven permit the pharmacist to rely on
"professional
judgment."
See, e.g., Alaska Division of Corporations, Business and Professional Licensure,
Pharmacy Statutes and Regulations, at Appendix C (providing that "a pharmacist shall
use the pharmacist's professional judgment to receive, store and use drug substances for
compounding prescriptions not foundin official compendia").
2 This report reflects research performed by examining state statutes and regulations relating to the
practice of pharmacy. Our research included searches in various databases (including WESTLAW and
LEXIS), as well as review of statutory codes, administrative codes and other compilations published by
various states and available online.