In Limbo: Legal Status of Pharmacy Compounding Uncertain
In Limbo: Legal Status of Pharmacy Compounding Uncertain
Perhaps pharmacists have seen the last of FDA activity in the compounding arena, at least for a while. Or maybe legal limbo is reopening doors for the agency to set its own limits in declaring where bulk compounding ends and manufacturing begins.
Those are two of the many possible scenarios that may result from a February federal court decision striking down the compounding section of the 1997 Food and Drug Administration Modernization Act (FDAMA). While some pharmacists and pharmacy groups have hailed the decision as a victory for the profession, the lack of any statutory limits could be a bane if future events create a perceived need for FDA to act aggressively.
No Safe Haven
To understand why Section 127 of FDAMA was important, one only needs to recall the position FDA took before the law was passed: Pharmacy compounding constituted manufacturing and, therefore, fell under the agency's regulations governing the pharmaceutical industry. Those rules, which require extensive expenditures to meet Good Manufacturing Practices, would effectively put pharmacists out of the compounding business.
In its decision in Western States Medical Center v. Shalala, the U.S. Court of Appeals for the Ninth Circuit seemed to rule that this FDA position was untenable. The court was considering an FDA appeal of a lower court ruling, which had held that the advertising portion of the section was unconstitutional in that it unreasonably interfered with commercial First Amendment rights to freedom of speech. But in its appeal, FDA asked the court of appeals to strike down the entire section if it found the advertising section unconstitutional. The court obliged.
Specific language in the court's decision should, in the short term, hinder FDA from continuing to make its earlier broad claims about the dangers of pharmacy compounding. The court ruled that FDA failed to do the following:
The court also noted that pharmacy compounding is legal under state law and that most states actually require pharmacists to know how to compound.
But the court's ruling was based on First Amendment considerations, and those present a very high legal bar. Should problems crop up with pharmacy compounding, FDA might not feel constrained in acting to regulate the practice in ways that would not affect such a basic constitutional right.
On March 23, the U.S. Department of Justice filed a petition with the Ninth Circuit asking for a rehearing of the Western States case.
Hiding Behind Compounding
The original problem that attracted FDA's attention -- "pharmacies" making large quantities of compounded preparations and distributing them for resale -- no doubt still exists. Will state boards of pharmacy be able to regulate these successfully, or will the need for a federal approach recur?
Randy P. Juhl, PhD, dean of pharmacy at the University of Pittsburgh and chair of FDA's Pharmacy Compounding Advisory Committee, believes that new legislation will be required to fill this legal void. He recommended three actions.
First, Juhl said, pharmacy needs a set of standards that say what compounding is, what the requirements are, and what the limitations are. Both the United States Pharmacopeial Convention (USP) and the American Society of Health-System Pharmacists have standards for sterile compounding (in the form of intravenous admixtures). But such extensive standards do not exist for nonsterile compounding, he said. Without them, pharmacists are susceptible to attacks from regulators who rely solely on existing laws. Juhl said a wise approach would be for the profession to partner with USP on development of such standards. USP is more than willing to participate, he added.
After such standards are recognized, state boards will need to adopt and enforce them, Juhl continued. This will require new and different kinds of expertise on the parts of pharmacy examiners, but he is confident that state-level regulation of organizations can be effective.
Third, Juhl said that organized pharmacy needs to go back to Congress, in partnership with FDA and consumer groups, to rewrite Sect. 127. "We need to establish in the law a good boundary between what FDA and state boards do," Juhl concluded.
Perhaps pharmacists have seen the last of FDA activity in the compounding arena, at least for a while. Or maybe legal limbo is reopening doors for the agency to set its own limits in declaring where bulk compounding ends and manufacturing begins.
Those are two of the many possible scenarios that may result from a February federal court decision striking down the compounding section of the 1997 Food and Drug Administration Modernization Act (FDAMA). While some pharmacists and pharmacy groups have hailed the decision as a victory for the profession, the lack of any statutory limits could be a bane if future events create a perceived need for FDA to act aggressively.
No Safe Haven
To understand why Section 127 of FDAMA was important, one only needs to recall the position FDA took before the law was passed: Pharmacy compounding constituted manufacturing and, therefore, fell under the agency's regulations governing the pharmaceutical industry. Those rules, which require extensive expenditures to meet Good Manufacturing Practices, would effectively put pharmacists out of the compounding business.
In its decision in Western States Medical Center v. Shalala, the U.S. Court of Appeals for the Ninth Circuit seemed to rule that this FDA position was untenable. The court was considering an FDA appeal of a lower court ruling, which had held that the advertising portion of the section was unconstitutional in that it unreasonably interfered with commercial First Amendment rights to freedom of speech. But in its appeal, FDA asked the court of appeals to strike down the entire section if it found the advertising section unconstitutional. The court obliged.
Specific language in the court's decision should, in the short term, hinder FDA from continuing to make its earlier broad claims about the dangers of pharmacy compounding. The court ruled that FDA failed to do the following:
Prove it has a substantial interest in preventing widespread compounding.
Support the opinion that increased distribution of compounded drugs is dangerous because of health risks associated with large numbers of patients taking such drugs.
The court also noted that pharmacy compounding is legal under state law and that most states actually require pharmacists to know how to compound.
But the court's ruling was based on First Amendment considerations, and those present a very high legal bar. Should problems crop up with pharmacy compounding, FDA might not feel constrained in acting to regulate the practice in ways that would not affect such a basic constitutional right.
On March 23, the U.S. Department of Justice filed a petition with the Ninth Circuit asking for a rehearing of the Western States case.
Hiding Behind Compounding
The original problem that attracted FDA's attention -- "pharmacies" making large quantities of compounded preparations and distributing them for resale -- no doubt still exists. Will state boards of pharmacy be able to regulate these successfully, or will the need for a federal approach recur?
Randy P. Juhl, PhD, dean of pharmacy at the University of Pittsburgh and chair of FDA's Pharmacy Compounding Advisory Committee, believes that new legislation will be required to fill this legal void. He recommended three actions.
First, Juhl said, pharmacy needs a set of standards that say what compounding is, what the requirements are, and what the limitations are. Both the United States Pharmacopeial Convention (USP) and the American Society of Health-System Pharmacists have standards for sterile compounding (in the form of intravenous admixtures). But such extensive standards do not exist for nonsterile compounding, he said. Without them, pharmacists are susceptible to attacks from regulators who rely solely on existing laws. Juhl said a wise approach would be for the profession to partner with USP on development of such standards. USP is more than willing to participate, he added.
After such standards are recognized, state boards will need to adopt and enforce them, Juhl continued. This will require new and different kinds of expertise on the parts of pharmacy examiners, but he is confident that state-level regulation of organizations can be effective.
Third, Juhl said that organized pharmacy needs to go back to Congress, in partnership with FDA and consumer groups, to rewrite Sect. 127. "We need to establish in the law a good boundary between what FDA and state boards do," Juhl concluded.
