Myth 1: DQSA grants the FDA sweeping authority in determining what pharmacies can compound.
Compounding sophisticated, difficult-to-produce drugs will not be prohibited. Traditional compounding pharmacies – those small operations which compound drugs that fill individual prescriptions – will still remain regulated by state pharmacy boards and will be too numerous for FDA to handle. Moreover, they likely will continue to enjoy the protection of the court, which has already determined that FDA does not have authority over the practice of pharmacy compounding. DQSA did not suddenly grant that authority. Compounding for a prescription is still perfectly fine. However, pharmacies that elect to become outsourcing facilities (ordinarily, larger operations would consider this) will be subjected to FDA’s regulation.
Myth 2: DQSA drew a clear distinction between pharmacy and outsourcing facilities.
The line between pharmacy compounding and manufacturing has always been a hazy yet important one. When a pharmacy compounds prospectively in large quantities without responding to specific prescription for a specific patient, ships over state lines in bulk quantities to others who commercialize the product, and otherwise, looks more like a manufacturer, FDA will regulate the pharmacy as a manufacturer of an unapproved and misbranded new drug. DQSA adds the new entity “outsourcing facility”, which is sort of a hybrid pharmacy/generic drug manufacturer. When DQSA takes effect, a pharmacy becomes a an outsourcing facility when it acts like one — when its conduct crosses over from traditional compounding to compounding bulk quantities of customized medicines, for intra- and/or inter-state distribution, with or without prescriptions, with or without a state pharmacy license. When a pharmacy crosses this line, FDA gains jurisdiction over the facility as an outsourcing facility and all the products it compounds will be subject to the new drug, adulteration, misbranding and drug track-and-trace provisions and requirements (that last one was also created by DQSA). Of course, if a compounding pharmacy (or other entity) voluntarily registers with FDA as an outsourcing facility, and meets all the conditions, it will be exempted from these provisions (except the adulteration provisions).
Myth 3: DQSA improves drug security and makes it easy for compounders to compound drugs in bulk.
Not really. One significant (and apparently) overlooked provision in DQSA virtually guts it, in one simple stroke. It is surprising, given the significance of this provision, that it has not been the key element in discussion about the policy. Although outsourcing facilities are promised exemptions from certain regulatory provisions, they only apply if the outsourcing facility does not use bulk drug substances (Active Pharmaceutical Ingredients, or APIs) in compounding (subject to exceptions controlled entirely by FDA). APIs are the source material used today to compound virtually every drug in the USA. Reducing the universe of potential drugs for compounding to those not starting with APIs is so drastic it is jaw-dropping. “I’m surprised that this escaped the attention of those who view the bill as a new opportunity for pharmacy compounding! I’m sure it didn’t escape the attention of drug manufacturers,” Ben England said. If compounding is so restricted for those facilities that elect to be outsourcing facilities, then why volunteer?
The Statute requires FDA to create lists of drugs that outsourcing facilities can compound using APIs – and of course, FDA would have to want to publish and populate such lists. The list, if ever established, will change frequently, leaving outsourcing facilities with little chance of actually purchasing APIs with any regularity.
Overall, the DQSA has made big strides in clarifying FDA’s authority over compounding. Nonetheless, whether the Bill is an effective approach in elevating drug safety remains questionable. A poorly-written drug safety bill will pave the way for more pharmaceutical fraud, resulting in more devastating public health problems in the future.
