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

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5. Compounding Copies of FDA-Approved Drugs
The vast majority of states impose no restriction on the compounding of copies of
FDA-approved drugs.
Only eight states impose limitations on substitution compounding. See Iowa Admin.
Code r. 657-20.3(1) (requiring a "significant difference" from the FDA-approved
product, which would include, for example, the removal of a dye for a medical reason
such as an allergic reaction); La. Admin. Code tit. 46, § 2533 (2007) (excluding from the
definition of compounding "the compounding of drug products that are essentially copies
of a commercially available product"); N.M. Code R. § 16.19.30.9 (2007) (requiring that
the commercial product not be reasonably available from normal distribution channels in
a timely manner to meet patient's needs and that the prescribing practitioner request that
the drug be compounded); 14-130-001 R.I. code R. § 1.19 (2007) (excluding from the
definition of compounding "the routine preparation, mixing or assembling of drug
products that are essentially copies of a commercially available product"); Utah Code
Ann. § 58-17b-102(18)(b) (2007) (excluding from the definition of compounding "the
preparation by a pharmacist or pharmacist intern of any prescription drug in a dosage
form which is regularly and commonly available from a manufacturer in quantities and
strengths prescribed by a practitioner"); 024-059-013 Wyo, Code R. § 3(a) (limiting to
medications or dosage forms that are not commercially available in the marketplace); 07-
02-0001 Ark. Code R. § I (requiring documentation provided by the prescriber of a
patient specific medical need or the unavailability of the drug product in the
marketplace); Wash. Admin. Code § 246-878-020(1) (requiring both the patient and the
prescriber authorize in writing the use of the compounded product); Alaska Division of
Corporations, Business and Professional Licensing, Pharmacy Laws and Regulations, at
Appendix C (requiring the authorization of the prescribing practitioner).
Two states expresslypermit such substitution compounding.
In Georgia and South Carolina, such compounding is specifically permitted when (I)
based on the existence of a pharmacist/patient/prescriber relationship and the presentation
of a valid prescription drug order; or (2) in anticipation of a prescription drug order based
on routine, regularly observed prescribing patterns. See Ga. Comp. R. & Regs. 480- 1l -
0.02 (2007); S.C. Code Ann. § 40-43-86 (2007).
CONCLUSION
Congress determined over 60 years ago when it enacted the FDCA that patients
receiving compounded drugs, like patients receiving commercially available drugs, are
entitled to protection under federal law as well as under state law. While opponents of
FDA oversight of pharmacy compounding argue that state regulation is adequate and
obviates the need for federal standards, it is clear that state laws and regulations fail to
provide many of the basic protections offered to patients under the current provisions of
the FDCA and under proposed revisions to the statute.
Dated: May 15, 2007
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