This past November the President signed HR 3204, the Drug Quality and Security Act, into law. This law could substantially limit what medications compounding pharmacies will be able to make.
The law requires ALL compounds to be made from Active Pharmaceutical Ingredients (APIs) that satisfy one of the following requirements:
1) The ingredient must have a USP/NF monograph
2) The ingredient must be a component of an FDA-approved medication
3) The ingredient appears on a list of APIs reviewed and approved by the Secretary of Health and Human Services (a so-called “Positives” List)
The FDA is currently accepting nominations of ingredients that do not already meet these requirements. Many of the drugs commonly prescribed by naturopathic physicians do NOT fall into one of the first two categories. These include but are not limited to Methylcobalamin, Glutathione and Choline.
In order to protect your patients’ right to safely compounded medications, we are requesting IMMEDIATE help in identifying those ingredients that do not fall into the above categories.
In addition to the names of such ingredients, the FDA is requiring the following information about them:
- Chemical name;
- Common name(s);
- Chemical grade or description of the strength, quality, and purity of the ingredient;
- Information about how the ingredient is supplied (e.g., powder, liquid);
- Information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to USP for consideration of monograph development; and
- A bibliography of available safety and efficacy data, including any relevant peer-reviewed medical literature
Also required is information about the RESULTING DRUG PRODUCTthat will be compounded using the given ingredients:
- Information about the dosage form(s) into which the drug substance will be compounded (including formulations);
- Information about the strength(s) of the compounded product(s);
- Information about the anticipated route(s) of administration of the compounded product(s);
- Information about the past and proposed use(s) of the compounded product(s), including the rationale for its use or why the compounded product(s), as opposed to an FDA-approved product, is necessary; and
- Available stability data for the compounded product(s).
Attached is preliminary list of APIs that has been assembled by the International Academy of Compounding Pharmacists (IACP). If you currently prescribe (or would like to prescribe in the future) ANY medication compounded from ingredients NOT included on this list,
WE ASK THAT YOU ACT NOW!
Please know that AANP has convened a Work Group that has been examining the implications of the new law, and will be commenting to the FDA on this and other significant issues. First and foremost is the ability of compounding pharmacies to continue supplying medications for office use. (A certain class of compounding pharmacies may be prohibited from doing so.) But if there are drug ingredients NOT on the IACP list that are essential to the compounded products you provide to your patients, PLEASE LET AANP KNOW THE NAMES OF THESE INGREDIENTS. Email Mike Jawer ([email protected]) BY FRIDAY, FEBRUARY 7. Furthermore, if you can supply the additional documentation that FDA is requiring to accompany the drug ingredient names (as per above), please email Mike by that same date AS THIS ADDITIONAL INFORMATION WILL BE IMPORTANT TO PROVIDE.
Beyond providing AANP with the information requested, you may also nominate drug ingredients directly with the FDA BY MARCH 4TH by clicking here:
THIS IS OUR LAST CHANCE TO PROTECT THE MEDICATIONS AND FORMULATIONS THAT YOUR PRACTICES AND PATIENTS DEPEND ON!
Thank you again to Mike Corrado of Civic Center Pharmacy for all of his assistance to the AzNMA in providing the information on HR3204.
