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.

Article on Federal Regulation of Compounded Drugs

An excellent article, Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split, appears in the 2010 American Society of Law, Medicine & Ethics, Inc., and Boston University (36 Am. J.L. and Med. 220).  The author is Jesse M. Boodoo.  A courtesy copy of the article can be read here.

A Suggestion from the American Podiatric Medical Association Regarding Compounding Pharmacies and Medication Errors

The following recommendation can be found at this link.

Due to recent medication errors made by compounding pharmacies, APMA recommends that if
you are purchasing medications from compounding pharmacies, you consider obtaining a letter
of attestation from the compounding pharmacy accompanying the deliverance of each drug to
your office. This letter of attestation would contain a statement verifying the content and
concentration of the medication provided.  Due to recent errors, at least one reaction was life
threatening, which involved a patient who received 70 times the correct dose of atropine in
capsule form directly from a compounding pharmacy. APMA is aware that there are
approximately 218 drugs in short supply according to the American Society of Health System
Pharmacists, and this is a crisis for patients, physicians and hospitals.