Crandall & Pera Law, LLC
Call 24/7 - Free Consultation
855-444-6651

The Future of Compounding Pharmacies

Questions continue to arise about the future of the compounding industry after 50 people were killed starting last fall by tainted steroid injections distributed by the New England Compounding Center.

Because most of the 2,700 pharmacists in the International Academy of Compounding Pharmacists (IACP) are much smaller than drug manufacturers, they have answered primarily to state pharmacy boards rather than the U.S. Food and Drug Administration.

While FDA inspections have been met with unease and confusion, they have proven necessary as 14 recent risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs have yielded deficiency findings so far. These FDA findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow, have been published online.

In order to close perceived loopholes, laws in 17 states have begun to make their way through state legislatures, some examining whether accreditation should be mandatory for compounding pharmacies, and others clarifying what constitutes a proper prescription.

"The FDA's authority over compounding companies is limited but not nonexistent," said Sarah Clark-Lynn, FDA spokeswoman. "While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers." Read the full details here:

Compounding Pharmacists Await Changes After Fungal Meningitis Scandal

The FDA had been cut out of the regulatory loop for compounding pharmacies, a law which only recently took effect and was clearly misguided. The recent fungal infection which led to numerous injuries and wrongful death, will spotlight the need for change.

If you or a loved one have been injured by a manufactured product, drug, medical device or medical malpractice leading to wrongful death or other injury, you should consult a qualified attorney to protect your rights. The lawyers of Crandall & Pera Law are available to help answer your questions and guide you in determining your next steps.

No Comments

Leave a comment
Comment Information
Email Us For A Response

The Respect And Dignity You Deserve

Our dedicated team of skilled trial attorneys and registered nurses have devoted their careers to seeking justice for clients just like YOU. Please reach out to us today at 855-444-6651 or via the Internet, we are only one call or email away. An initial consultation is free and comes without strings.

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy

Office Locations

Cincinnati Office
36 East 7th St.
Suite 2610
Cincinnati, OH 45202

Toll Free: 855-444-6651
Cincinnati Law Office Map

Cleveland Office
850 Euclid Ave.
Suite 1122
Cleveland, OH 44114

Toll Free: 855-444-6651
Cleveland Law Office Map

Columbus Office
35 E. Gay St.
Suite 226
Columbus, OH 43215

Toll Free: 855-444-6651
Columbus Law Office Map

Cincinnati Office
1095 Nimitzview Dr.
Suite 403
Cincinnati, OH 45230

Toll Free: 855-444-6651
Cincinnati Law Office Map

Chesterland Office
12768 Chillicothe Rd.
Suite 210
Chesterland, OH 44026

Toll Free: 855-444-6651
Chesterland Law Office Map

Lexington Office
1900 Cambridge Dr.
Suite 101
Lexington, KY 40504

Toll Free: 855-444-6651
Lexington Law Office Map

Chagrin Falls Office
15 1/2 N. Franklin St.
Chagrin Falls, OH 44022

Toll Free: 855-444-6651
Chagrin Falls Law Office Map