California Guidance Regarding Compounding

The state of California has a website that contains specific questions and answers regarding the compounding laws and regulations in that state.  Click here to read that guidance.

Chemical Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations

USP 797 is an important tool in the compounding world.  Sterile Compounding Pharmacies need ot be compliant with 797.  The International Journal of  Pharmaceutical Compounding has a number of helpful articles about 797.  One entitled, Chemical Testing Aspects of USP Chapter 797 for Compounded Sterile Preparations,  discusses quality controls.  To read the article, click here.

13 Vacancies on the FDA Pharmacy Compounding Advisory Committee

As of May 1, 2012, the FDA has 13 vacancies on the Pharmacy Compounding Advisory Committee.  A summary of that committee found here is reproduced below:

Pharmacy Compounding Advisory Committee

Provides advice on scientific, technical, and medical issues concerning drug compounding by pharmacists and licensed practitioners.

Knowledgeable in the fields of pharmaceutical compounding, pharmaceutical manufacturing, pharmacy, medicine and other related specialities.

13

INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets - Veterinarians

On April 20, 2012, the U.S. Food and Drug Administration (FDA) approvedf INCURIN (estriol) Tablets and PROIN (phenylpropanolamine hydrochloride) Chewable Tablets to control urinary incontinence in dogs. The FDA noted:

By prescribing FDA-approved INCURIN and PROIN, you provide your clients and their dogs with the only marketed estriol and phenylpropanolamine products shown to be safe and effective for controlling urinary incontinence in dogs. INCURIN and PROIN are also the only marketed estriol and phenylpropanolamine products that are manufactured to meet FDA’s strict standards for quality, purity, and potency.

Please be aware that estriol and phenylpropanolamine products should not be imported from other countries for use in animals. In addition, bulk estriol and phenylpropanolamine should not be used to compound animal drugs.

The FDA also reminded veterinarians about compounding other strengths or dosages of INCURIN AND PROIN: 

A compounded animal drug is not FDA-approved. This means FDA has not evaluated the safety and effectiveness of the compounded drug or the adequacy of the manufacturing process. 

You may have specific patients that need estriol or phenylpropanolamine in strengths or dosage forms not offered by INCURIN or PROIN. In these limited cases, estriol or phenylpropanolamine can be legally compounded by using FDA-approved INCURIN or PROIN as the source of the active pharmaceutical ingredient. Please find additional requirements for legal animal drug compounding at Title 21, Code of Federal Regulations, Section 530.13.

To read entire FDA notice, click here.