April 30, 2013
While there are good things about the proposed federal compounding legislation, there are also somethings that make this not the best possible legislation that Congress can pass. Here are ten reasons that the proposed compounding federal legislation is not a good idea to pass in its current form:
1. Congress appears to be rushing to pass Federal legislation without taking the time to allow all affected parties time to analyze this legislation. While Congress is asking for comments, they are not allowing much time to submit those comments. Comments are due May 3, 2013.
2. There are currently state rules and regulations covering some of the same areas. These state rules and regulations need to be enforced. Adding more piecemeal regulations when the current ones are not enforced makes little sense.
3. The FDA already has jurisdiction over manufacturers. If a compounding pharmacy is engaged in manufacturing the FDA should already be enforcing its laws. A new category muddies the water, creates more gray area, and leaves open more areas for litigation.
4. This proposed legislation contains a number of loopholes. The bad compounders will continue to find ways around the legislation and use the loopholes to their advantages.
5. The labeling requirements should not only require the name, address, and phone number of the applicable compounding manufacturer, but should also require the name of the pharmacist responsible for preparing the compound.
6. Exempting hospitals pharmacies who ship interstate within a hospital system from the definition of compounding manufacturer or to excuse them from registration with the FDA will not save lives or ensure public safety. People receiving these compounds deserve the same protections as everyone else.
7. Charging a $15,000.00 fee for inspections may cause some good compounders to stop compounding much needed drugs. This is a huge amount to be charged for inspections. In addition the compounder must pay 100 percent of the cost of reinspection.
8. Only covering preparations prepared without a prescription or in advance of prescription does not ensure public safety. Compounds prepared with a prescription can also be deadly. Just because the number of deaths may not be as great as in NECC this does not mean we should not do everything we can to prevent all deaths from bad compounds.
9. This legislation will require the larger compounders who prepare prescriptions in advance of prescription or without a prescription to be monitored by the FDA but in no way ensures a way for the FDA to monitor, inspect or keep track of the "bad compounders" who do not fit the proposed definition.
10. The legislation creates a number of areas such as who is a compounding manufacturer that could be highly litigated and take years to be settled by courts. The "bad compounders" who probably meet these definitions will have the resources and money to tie these issues up for years in court, which in effect does not truly advance the ball as far as public safety.
As a side note, Congress is spending too much time trying to place blame on someone when in truth the blame is shared by a number of people--the FDA, the states, bad compounders, organizations and lobbyists, doctors and vets not demanding the highest quality of compounds, and the public for not being educated and knowledgeable and demanding more from doctors, vets, pharmacists, the FDA and states. Congress needs to be careful to not adopt legislation that actually punishes the the good compounders who are are making every effort to play by the rules.