ACT
STOP UNNECESSARY USP REGULATIONS
Support Bill HR-1959
Nutritional Substances List
USP guidelines are also being revised. The proposed guidelines severely limit the scope of compounding pharmacies to the point that compounding outside of a hospital may no longer be feasible. The proposed USP guidelines are currently under appeal.
The purpose of the new regulations was to ensure public safety however the current legislation ensures safety by eliminating nutritional compounded products almost entirely and significantly reducing what can be compounded. The 2012 tragic incident of 64 deaths from contaminated steroids which prompted new regulations in the compounding industry were due to faulty manufacturing and had nothing to do with the source materials. The product manufactured was a steroid, not a nutritional product.
Since that time, numerous new safety regulations have been enacted and today's existing compounding pharmacies all employ these very high safety standards. Recent USP modified guidelines restrict patient access to medications. Creation of the approved substance list does not enhance safety. It only eliminates access to many beneficial medicines. In essence the entire industry of nutritional medicines will become extinct. This is a case of regulation into extinction.
Representative Griffith (R-VA) has brought forth HR-1959 Preserving Patient Access to Compounded Medications Act of 2019. This bill maintains all safety measures set forth for the compounding industry but allows for continued production of the many necessary and highly useful medical compounds.
Write your representative by clicking on the action link. (external website)
Nutritional Substances up for Review
The FDA is reviewing substances that compounding pharmacies may use. They will determine whether a substance has any medicinal value. To date approximately 400 substances have been submitted for review. 350 were immediately denied without opportunity for comment or presentation by proponents. The Board deemed that these 350 substances did not merit an official hearing. Of the those that remain, most have been denied. To date only 16 have been approved, of which 6 are only approved for topical use.
Other reasons for non-merit of evaluation of a substance include the Board's lack of perceived need for what the substance treats. For example, Curcumin is often used as an anti-inflammatory. During the hearings it was stated that there is no need for additional anti-inflammatories because we have FDA approved drugs like Ibuprofen. As we now know, ibuprofen is very hard on the kidneys and is not recommended for diabetics. We also know that long term use injures the digestive system and may cause ulcers. Curcumin does not. Other nutritional substances that did not merit review where those that help the symptoms of cancer. The FDA stated that there are already FDA approved cancer drugs, so no more are needed. (These accounts can be read in the Federal Register).
Eliminating source materials reduces patient access to many drugs. Compounding pharmacies specialize in providing medications to people who need medicines that are not made by pharmaceutical companies. This can be nutritional medicines that are simply not available elsewhere, it can mean custom compounding without ingredients to which a patient is sensitive, or it can mean customized dose or route of administration (nebulizer, subligual, in a lollipop for children, etc.).