ESTRIOL

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Obtaining an IND for Estriol

Some menopausal hormone therapy drugs compounded by pharmacies contain the

ingredient estriol. Estriol is not a component of any FDA approved drug and it

has not been shown to be safe and effective for the uses for which it is being

prescribed.

Under a well-established policy, pursuant to an Investigational New Drug

Application (IND), FDA permits drug compounding with active ingredients that -

like estriol - are not components of FDA-approved drugs. The Agency's position

has been improperly cast as a ban on estriol. But FDA has repeatedly stated that

it respects a healthcare provider's decision that his or her patient should

receive estriol.

At the same time, FDA must assure that patients receive accurate information

about the risks and benefits of unapproved drug therapies so that they can make

informed decisions about those therapies. The requirement for patients to give

informed consent when receiving a product under an IND ensures that patients

receive important safety information. Another advantage of INDs is their

requirement that practitioners collect and report adverse event information to

FDA.

There are some misconceptions that obtaining an IND is a costly, cumbersome, and

time consuming process. To the contrary, INDs are well known, well understood,

and widely used in the healthcare community. Thousands of physicians use INDs

every day to treat patients with drugs that have not been approved by FDA. FDA

does not charge a fee to file an IND, although review fees may be charged by

private Institutional Review Boards. In addition, FDA has streamlined the IND

process for estriol to make it as efficient and convenient as possible for

practitioners, while still maintaining patient safety.

Under this streamlined process, FDA is willing to accept INDs covering multiple

patients, on behalf of multiple health care providers, and for a range of doses.

The general requirements for practitioners filing an IND application for estriol

are:

Completed FDA Form 1571 [PDF ]

Drug formulation and chemistry information including:

Names and addresses of the pharmacies making the drugs

Attestation from the pharmacies that they will use only USP/NF grade ingredients

and adhere to USP processes and procedures when preparing the compounded

products

Detailed description of the drug formulation that will be used (ingredients,

quantities, and production processes)

Clinical information including:

Number of patients

Types of symptoms that will be treated by the drugs

Dose ranges for each formulation

Monitoring procedures, including safety monitoring

Copy of current medical license of the practitioner

For more information regarding IND or new drug application submissions for drugs

containing estriol, please contact Margaret Kober in the Division of

Reproductive and Urologic Products at .

Please submit all completed IND applications for estriol to the following

address:

Food and Drug Administration

Center for Drug Evaluation and Research

Central Document Room

5901-B Ammendale Road

Beltsville, MD 20705

Attn: Margaret Kober

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Date created: July 16, 2008; updated August 1, 2008