Maybe this will help further confuse everyone. Take care. Billylll

Before passage of the 1938 act, patients could acquire from pharmacists any nonnarcotic drug without a prescription order. Patients who felt ill could obtain a medication order from a physician or could instead consult a pharmacist. Pharmacists could make recommendations for patients, and they could dispense a drug simply because a patient requested it. In this way, patients, physicians, and pharmacists shared responsibility for the acquisition and use of nonnarcotic drugs. In late 1938, several months after the new act took effect, FDA set in motion a series of events that would take this responsibility away from patients and pharmacists and concentrate it in the hands of physicians.

FDA interpreted the 1938 act’s exemption from labeling disclosure requirements to mean that, among other conditions, if a drug was dispensed pursuant to a prescription order, then it need not be labeled with directions and warnings.4 To be sure that a drug would be dispensed pursuant to a prescription order, FDA required that the label bear a prescription-only warning, that other warnings be directed to health care professionals, and that the drugs be shipped solely for sale pursuant to a prescription. The federal “legend” was thus born, separating so-called “legend” and “nonlegend” drugs. By permitting manufacturers to label their products, “Caution: To be used only by or on the prescription of a _____” (with the blank to be filled in with physician, dentist, or veterinarian), FDA permitted manufacturers to create a class of drugs that could not be used without a prescription.

This FDA interpretation was not discussed when Congress passed the 1938 act. It was not specifically authorized under the act, and it was taken without an opportunity for comment or compromise. Over the next several years, things began to sort themselves out with little coordinated input from pharmacists into their profession’s own governance. During World War II, attentions were apparently turned to other matters. The difficulty some pharmacists faced in practice was that the labeling of pharmaceuticals determined the standard for dispensing (with or without a prescription order), and this standard was applied in different ways by different manufacturers. One manufacturer of a drug might choose to use the federal legend, while another manufacturer of the same drug might choose not to. It is hard to imagine how the most fundamental of pharmacist responsibilities could be left to the whims of a manufacturer’s marketing decisions.

The chaotic situation pharmacists faced in practice was put in order by the Supreme Court in 1948. In United States v Sullivan,5 the Court affirmed the conviction of a pharmacist who had dispensed, without a prescription order, a medication that bore the federal prescription legend when received from the manufacturer. Never mind that the same medication made by other manufacturers did not bear the legend and would not have led to a prosecution. This case established the important principle that federal law applies to the dispensing of a medication by a pharmacist to a patient within a state. It may be counterintuitive to believe that this intrastate transaction could be considered “interstate commerce” subject to federal regulation under the provisions of Article 1 of the Constitution, but the Court held that it was. The most significant aspect of this case was the court’s firm recognition that FDA and the pharmaceutical manufacturers had authority to assign to physicians—at the expense of pharmacists and patients—complete responsibility for controlling patients’ acquisition of the most useful medications.

The legislative reaction to this development was not what one might have expected. Rather than opposing it or seeking a compromise based on decades of responsibility over decisions about medication use, many pharmacists embraced it and sought to institutionalize it. Senator Hubert Humphrey and Congressman Carl Durham, both pharmacists, introduced legislation that would, for the first time ever, formally establish a uniform prescription-only class of drugs.6 This legislation took effect in 1952 and led to the clear separation of dispensing pharmacists from prescribing physicians.

Why would some pharmacists be so eager to limit themselves in this way? Perhaps the answer lies in the provisions of the act regulating dispensing of refills and verbal authorization to dispense. Before 1952 it was not clear that refills could be legally authorized or that any order other than a written order was legally sufficient as a prescription. The Durham–Humphrey amendment to the FDCA clarified that refills and verbal orders were clearly permissible under the law. Apparently, the tradeoff for this concession was relinquishment of any claim of responsibility pharmacists may have had on initiation of therapy. The amendment carved out a “safe harbor” for pharmacists, who were made secure in their dispensing role but utterly excluded from primary decisions about medication use.

By 1952 pharmacists had become, through governance, what they sought to be: respected custodians of the nation’s drug supply, at the tail end of the chain of distribution. This is an important role, but not a fulfillment of the promise of the profession in 1902, when an expansive patient-oriented practice appeared to be developing. Pharmacists had given over to physicians primary responsibility for making decisions about drug therapy. It would take another half-century for pharmacists to begin taking this responsibility back.

David B. Brushwood, JD, is a pharmacist and professor of pharmacy health care administration, College of Pharmacy, University of Florida, Gainesville.