Magazine article Drug Topics

Under DQSA, FDA Reins in Compounding

Magazine article Drug Topics

Under DQSA, FDA Reins in Compounding

Article excerpt

Sometimes it takes a significant crisis to forge the adoption of appropriate government regulations. Passed last November, the Drug Quality and Security Act (DQSA) is a direct response to the aftermath of the devastating fungal meningitis outbreak linked to the New England Compounding Carter (NECC). The legislation, intended to regulate compounding pharmacies and establish a trackand-trace pedigree system for drugs, has engendered a sigh of relief in some patient-safety circles.

Impetus for DQSA

"The NECC catastrophe highlighted dangers of unregulated, large-scale compounding," said Christopher J. Topoleski, BA director of Federal Regulatory Affairs at the American Society of Health-System Pharmacists (ASHP), Bethesda, Md.

After a federal investigation of outsourcing facilities, the FDA and Congress determined that poor regulatory coordination and gaps in pharmacy oversight may have contributed, in part, to the fungal meningitis outbreak.

For decades, the FDA has had authority to regulate drug manufacture, but the compounding of "designer therapeutics" has fallen into a gray area between state and federal oversight. Critics of the previous system assert that the optimal way to balance the need for custom medications with the need for product safety is to give FDA broader powers to regulate compounders.

Traditional compounding

Except for removal of advertising prohibitions, section 503A of the new legislation is essentially unchanged and "applies to all licensed physicians and pharmacists who are engaged in compounding or who compound for individual patients based upon a valid prescription," said David G. Miller, RPh, executive vice president and CEO, International Academy of Compounding Pharmacists (IACP) in Alexandria, Va.

In this case, the standards are dear. The pharmadst can use only drugs that: are part of an accepted nationwide standard, have not been withdrawn or removed from the market for safety or efficacy reasons, are not on a "demonstrably difficult" to compound list, and are not "copies" of commerdally available products.

Topoleski said that ASHP is asking FDA for further guidance, such as an unambiguous definition of "demonstrably difficult" and an updated drug products list to replace the current one, which was created 15 years ago. Miller noted that "future handling of homeopathic products, dietary supplements, and OTC products still remains unknown."

Pharmacies that ship products across state lines must operate in a state that has signed a memorandum of understanding (MOU) with FDA. In the absence of such an agreement, they can distribute no more than 5% of the total prescription orders to another state.

Miller believes that the new legislation has not really changed compounding practices for traditional compounders, but it has raised some unanswered questions about what practitioners are to do in day-to-day patient care when current state and federal laws appear to conflict or when prescribers do not understand or believe that this law applies to them as well. "Doing the 'right' thing for the patient may actually conflict with the law," he said.

New "outsourcing facilities"

The establishment of the new "outsourcing facility" 503B category creates the opportunity for custom sterile drug compounders to voluntarily register with the FDA.

Topoleski considers the new law a pathway for increased patient safety and information transparency; it will help ensure that compounding entities are compliant with current good manufacturing practices (cGMP) requirements and are subject to routine and risk-based FDA inspections, much as are drug manufacturers.

"A 503B outsourcing facility must report which products they are compounding and any associated adverse events," said Topoleski.

Under the new bill outsourcing facilities are also not allowed to compound copies of drugs already on the market, unless they are on a drug shortage list. …

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