Compounding and the FDA
With Jeffrey S. Baird
Q. On April 29, 2002, the U.S. Supreme Court issued a decision in Thompson v. Western States Medical Center ("Western States Case"), holding that the prohibition against advertising compounded drugs found in Section 503A of the Food and Drug Administration Modernization Act (FDAMA) is an unconstitutional restriction of commercial speech. From a practical standpoint, what does this mean to a compounding pharmacy?
A: Section 503A exempts compounded drugs from FDA drug approval requirements as long as pharmacies comply with certain restrictions. On appeal, the U.S. Supreme Court was asked to review the freedom of speech issue but was not asked to review the 9th Circuit Court of Appeals decision that the advertising restriction could not be severed from the other provisions of Section 503A. The Supreme Court affirmed the 9th Circuit's decision. As a result, all of Section 503A has been stricken from FDAMA.
Now pharmacies throughout the United States can advertise specific compounded drugs, classes of drugs and types of drugs. Remember, however, that the FDA retains its ability to regulate drug manufacturers. Even though Section 503A is no longer in effect, it would be prudent for pharmacies to adhere to the balance of Section 503A which address items that the FDA evaluates in determining when a pharmacy has crossed over the line into manufacturing. By adhering to that portion of Section 503A that is unrelated to advertising, the pharmacy will substantially protect itself from a claim by the FDA that it is engaged in manufacturing unapproved drugs.
Jeffrey S. Baird, Esq. is chairman of the Health Care Group of Brown & Fortunato, P.C., Amarillo, Texas. Reach him at (806) 345-6320 or jbaird2bf-law.com.