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

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Only one state, Utah, requires that active ingredients be approved by FDA for some
medical use.
See Utah Admin. Code r. 156- 17b-614(3)(d). Of the three remaining states, one requires
that the ingredients meet or exceed USP/NF standards, see Nev. Admin. Code § 639.757,
and two require that the chemical be procured from another entity registered by that
state's board, see 3 Colo. Code Regs. § 719-1.00.24 and Mo. Code Regs. Ann. tit. 20, §
2220-2.400.
3. Determination of Medical Necessity.
* No state other than Arkansas requires documentation ofmedical necessity prior to
dispensing a compounded product.
In Arkansas, a pharmacist must obtain documentation of a "specific medical need" when
the compounded product is "essentially a copy" of a commercially available FDAapproved
drug product. 3
4. Standards for Compounding Sterile Pharmaceutical Products
* Onlyfour states require compliance with the United States Pharmacopoeia
(USP) chapter on sterile compounding.
The USP, a private entity recognized in the FDCA with regard to certain pharmaceutical
standards, has provided a chapter containing standards for sterile compounding (USP
) that is intended to be mandatory. The USP standards are far less strict than FDA
standards for approved drugs and provide patients with less protection. Although
opponents of FDA oversight of sterile compounding point to the USP standards as an
alternative to the higher FDA standards, compounding interests have opposed adoption
by the states of the USP requirement and the states have generally failed to adopt the USP
chapter as a requirement. Only four states have adopted the USP chapter. See Utah
Admin. Code r.156-17b-19 (2007); N.M. Code R. § 16.19.6.11 (2007); 856 Ind. Admin.
Code 1-30-1, et seq. (2007); 247 Mass. Code Regs. 9.01(3) (2007).
3 The Arkansas rule provides:
Compounding a drug product that is commercially available in the marketplace or that is
essentially a copy of a commercially available FDA-approved drug product is generally
prohibited. However, in special circumstances a pharmacist may compound an appropriate
quantity of a drug that is only slightly different than an FDA-approved drug that is commercially
available based on documentation provided by the prescribing physician of a patient speci ic
medical need (e.g. the physician requests an alternate product due to hypersensitivity to excipients
or preservative in the FDA-approved product, or the physician requests an effective alternate
dosage form) or if the drug product is not commercially available. The unavailability of such drug
product must be documented prior to compounding. The recommended methodology for
documenting unavailability is to print the screen of wholesalers showing back-ordered.
discontinued, or out-of-stock items." Id (emphasis added).
070-02-0001 Ark. Code R. (2007).