Minnesota Board of Pharmacy - Minnesota State Legislature

Food, Drug and Cosmetic Act
21 USC Section 353, the part of the Food, Drug and Cosmetic Act (FDCA) that distinguishes between
prescription and non-prescription drugs, states in part (and with emphasis added):
“(b)(1) A drug intended for use by man which—
(A) because of its toxicity or other potentiality for harmful effect, or the method of its
use, or the collateral measures necessary to its use, is not safe for use except under the
supervision of a practitioner licensed by law to administer such drug; or
(B) is limited by an approved application under section 505 to use under the
professional supervision of a practitioner licensed by law to administer such drug; shall
be dispensed only (i) upon a written prescription of a practitioner licensed by law to
administer such drug, or (ii) upon an oral prescription of such practitioner which is
reduced promptly to writing and filed by the pharmacist, . . . The act of dispensing a
drug contrary to the provisions of this paragraph shall be deemed to be an act which
results in the drug being misbranded while held for sale”.
Unless a practitioner is licensed by law, it is illegal under this section of the FDCA for a prescription
drug to be dispensed to any person. If the boards that license physicians, physician assistants, advance
nurse practitioners, dentists, podiatrists and optometrists were abolished and if the state no longer
licensed those practitioners, Minnesotans would not have legal access to prescription drugs (unless they
were prescribed by practitioners licensed in other states or the federal government somehow waived
this legal requirement).
While this language does not include the word “licensed” before the word “pharmacist”, all states
licensed pharmacists when this language was passed in 1952. It is a fairly safe assumption that
Congressional intent was for licensed pharmacists to fill the prescriptions written by licensed
practitioners. Other sections of the FDCA do specify that pharmacists must be licensed in order to
perform certain activities such as compounding. (See 21 USC Section 353a).
21 USC Section 353 also contains the Prescription Drug Marketing Act provisions of the FDCA which
were signed into law by President Ronald Reagan in 1988. One portion of this section reads (emphasis
added):
“No person may engage in the wholesale distribution in interstate commerce of drugs subject to
subsection (b) in a State unless such person is licensed by the State in accordance with the
guidelines issued under subparagraph (B)”.
In Minnesota, as in many states, the Board of Pharmacy licenses drug wholesalers. Consequently, if the
Board was abolished and if the state stopped licensing drug wholesalers, those wholesalers could not
operate within Minnesota. Again, Minnesotans would have difficulty accessing needed prescription
drugs.
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