Statement from the FDA Commissioner on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

03,September 2018

The FDA has stressed the need for closer collaboration with states on taking steps to reduce the risks associated with compounded drugs, even as it seeks to ensure complete access to them. Towards fostering this collaboration, the FDA issued a set of revised draft memoranda of understanding (MOU) between it and the states.

The aim of signing these MOU's is to collaborate with the states and pool and combine the resources available at each other’s disposal to ensure better health for those seeking treatment with compounded drugs.

Understanding compounded drugs

First, an understanding of compounded drugs: Compounded drugs are personalized medications for individual patients. Compounders, who are pharmacy professionals who assist doctors and practice in many areas of the world, customize medications prescribed by the doctor according to the exact mix of ingredients to suit the needs of the patient. What mass production medicines do is to fix a standard formulation or strength. This may or not be suited to the individual needs of a particular patient.

A compounder makes sure that these are added in the right proportion as prescribed by the doctor. The compounder could take parameters such as dosage forms, flavors, strengths and ingredients that the patient could be allergic to, from the preparation. This is why this practice is pretty popular to this day. Many patients favor compounded drugs because the compounder takes care to supply the drug with the exact specification of the drug ingredients that could be of the most effective use to the patient.

Challenges for the FDA

However, the popularity of this form of medication notwithstanding, compounded drugs pose a challenge for the FDA. Compounded drugs are not approved by the FDA. Since they are not FDA-approved, the FDA does not vouch for the safety or effectiveness of these drugs. These drugs do not go through the usual stringent regulatory process such as Premarket Approval that other drugs do. The FDA could be concerned about the dosage, a small variation in which can cause serious problems for the patient but is in no position to do anything about it. It has no oversight or control of the conditions in which these medications are prepared, administered or marketed.

Once a compounder distributes a compound drug, it is difficult to track it because there is no batch or lot number or any other tracking or documenting procedure. The meningitis outbreak of 2012, which was traced to a fungus from a compounded drug, is just one example of the dangers of compounded drugs.

It is with the intention of overcoming these challenges that this latest MOU was signed. It builds on the draft MOU of 2015, which invited public comments on how to deal with spurious or dangerous compounded drugs. Revisions to this draft were worked out in consultation with the National Association of Boards of Pharmacy.

The new guidelines

This reissued MOU looks at the issue of the percentage of compounded drugs that are distributed interstate, known as the inordinate amounts. According to the 2015 MOU, states could take action against compounders when this amount exceeded 30 percent of the total sale from a pharmacy.

This has been fixed at 50 percent by the new MOU. The aim is to restrict the sale of specialized compounded drugs and to help track them across the states. States can take a risk based, flexible approach to the issue of inordinate amounts for interstate drug distribution.

When a pharmacist, a pharmacy, or a physician located in a state that has not entered into the MOU distributes compounded drugs outside the state, it is allowed to do so for only five percent of this total prescriptions. This new MOU removes this restriction for drugs compounded by outsourcing facilities and to veterinary drugs. The main reason behind this is that outsourcing facilities could go about preparing compounded drugs without fully understanding the specifications and ensure quality.

The FDA will send the MOU to states for signatures over a six-month period. During this time, the five percent rule will not be enforced.