Like the Senate bill, the House bill grants an FDA request to create another class of compounding pharmacies (back story). The agency believes that traditional compounders, which mix or alter ingredients for individual patients on an as-needed, should be distinguished from ‘non-traditional’ compounders that sell high volumes and ship out of state because these activities may pose a higher risk (here is the House bill and here is the Senate bill).
There are other similarities: the House bill also calls for compounders to register with the FDA and inform the agency of products that are made; production must be overseen by a state pharmacist; adverse events must be reported and investigated; and only ingredients complying with US Pharmacopeia or National Formulary monograph standards can be used.
However, the House bill is less stringent in one key regard. The Senate bill says that FDA oversight begins when a compounder ships sterile product out of state without a prescription for a specific patient. But the House bill says a compounder is subject to FDA oversight only when such activities constitute 5 percent or more of its business. In either case, though, FDA approval is not required of the drugs made.
The language between the bills must still be reconciled, but the 5 percent threshold suggests some challenges. For instance, such a percentage will represent a different amount of business for different companies, which means some compounders will be manufacturing and shipping much more than others before FDA oversight begins.
Another unanswered question is how Congress attempts, as a practical matter, to help the FDA determine when a company has reached that threshold. The agency has already complained bitterly that it has lacked the legal resources to pursue enforcement actions against recalcitrant compounders under the existing system (see this). How will the agency now determine when compounders exceed 5 percent?
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