Why an FDA Document Could Mean an End to Many Compounded Medications

The FDA’s recent guidance on drug compounding—together with the underlying legislation passed by Congress last year—contain a number of proposed regulations that are harmful to doctors, patients, and compounding pharmacists. Already the Senate Appropriations Committee has criticized the FDA for issuing proposed new regulations on compounding pharmacies without sufficiently consulting the stakeholders.

Three provisions in the new guidance are particularly troubling:

No More “Office Use”

This is an area of the rulemaking that has garnered the biggest negative reaction from the compounding community. Instead of allowing a doctor to dispense compounded drugs from his or her office, the FDA will now be requiring a patient-specific prescription for all drugs compounded, with a narrow exception if the compounding is based on an established relationship with the patient. The FDA will bring action against traditional compounders who do not require prescriptions before they dispense compounded medications. 

This conflicts with state laws governing the pharmacist-prescriber relationship, and it impinges on the doctor-patient relationship. Keeping a supply of medications for office use allows doctors to respond quickly to patients in need of treatment; it also ensures patient compliance, and allows the physician to monitor physical reactions. Limiting office use does nothing to improve patient safety and instead limits doctors’ ability to do what is best for their patients.

The 5% Rule

Traditional compounders (as opposed to large outsourcing facilities) are, under this guidance, allowed to send only 5% of their sales out of state. This is an arbitrary limit on the movement of compounded drugs that has no impact on the health and safety of patients. The only plausible benefit of the rule would be to large drug companies who wish to limit access to compounded medications that compete with their drug sales.

Bulk Ingredient Lists and “Clinical Need”

The FDA has asked for nominations for “bulk ingredient” lists, which will delineate which drugs may be used by traditional compounders and outsourcing facilities. Pharmacies and medical professionals have attempted to nominate the most important compounding ingredients for the lists; however, the FDA has asked for information to be included in the nomination process that is extremely difficult to compile, especially given the limited timeframe provided.

In the underlying statute, Congress stated that to be on the approved list, there must simply be a "clinical need" for the bulk drug substances. The FDA now says the nominator must:

Note that the FDA is saying that there must be an existing market for this product and it must be of some size. New products, or old products that might prove useful in new ways or for new populations, will be barred.

How You Can Help

In order to protect the integrity of the doctor-patient relationship and preserve access to compounded drugs, we must call on Congress to fix the provisions of the Food, Drug, and Cosmetic Act that relate to compounding, and ask them to direct the FDA to change their regulations.

Please sign this petition to let Congress and the FDA know that you value access to personalized healthcare and respect for the doctor-patient relationship. 

Recipients

  • Your Senators
  • Your Representative
  • Stephen Ostroff

Contact

*Required fields
 
 

Message

Please Protect Compounded Medications!

Dear [Decision Maker],

Compounded medications are vital to the health of many Americans and an important tool for personalized medicine. Recent regulations proposed by the Food and Drug Administration (FDA) are a blatant power grab that would benefit the mainstream pharmaceutical industry and crush small, independent compounding pharmacies. Already the Senate Appropriations Committee has criticized the FDA for issuing proposed new regulations on compounding pharmacies without sufficiently consulting the stakeholders.

The FDA's latest draft regulations on compounding include a number of proposed rules that are harmful to doctors, patients, and compounding pharmacists.

Instead of allowing a doctor to dispense compounded drugs from his or her office, the FDA will now be requiring a patient-specific prescription for all drugs compounded, with a narrow exception if the compounding is based on an established relationship with the patient. The FDA will bring action against traditional compounders who do not require prescriptions before they dispense compounded medications.

This conflicts with state laws governing the pharmacist-prescriber relationship, and it impinges on the doctor-patient relationship. Keeping a supply of medications for office use allows doctors to respond quickly to patients in need of treatment; it also ensures patient compliance, and allows the physician to monitor physical reactions. Limiting office use does nothing to improve patient safety and instead limits doctors' ability to do what is best for their patients.

Traditional compounders (as opposed to large outsourcing facilities) are, under this guidance, allowed to send only 5% of their sales out of state. This is an arbitrary limit on the movement of compounded drugs that has no impact on the health and safety of patients. The only plausible benefit of the rule would be to large drug companies who wish to limit access to compounded medications.

The FDA has asked for nominations for "bulk ingredient" lists, which will delineate which drugs may be used by traditional compounders and outsourcing facilities. Pharmacies and medical professionals have attempted to nominate the most important compounding ingredients for the lists; however, the FDA has asked for information to be included in the nomination process that is extremely difficult to compile, especially given the limited timeframe provided. The FDA's misinterpretation of the term "clinical need" is an overly burdensome requirement that was never intended by Congress.

In order to protect the integrity of the doctor-patient relationship and preserve access to compounded drugs, I call on my legislators to fix those provisions of the Food, Drug, and Cosmetic Act that relate to compounding. I also ask you to direct the FDA to change its regulations.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]