Dr. Allen, Expert on Compounding, Points Out Misrepresentations by the Press

Here is part of Dr. Allen's Editorial that appears in the Compounding Today Newletter:

Editorial: Misrepresentations by the Press

Those keeping up with the events in Massachusetts have no doubt read many accounts of the events and the answers to questions posed to pharmacy leadership by the press. Most reporters have very little, if any, knowledge of pharmacy compounding and are either unaware or seemingly don't care if they are not accurate and complete in their reporting.

A specific comment I would like to address is that some reports have misquoted statements that say that compounders want lower standards. This is absolutely false! Pharmacists, pharmacy compounding leadership, and company CEOs involved in providing support to compounding pharmacies want strong quality standards, and they work hard for strong quality standards.

What many reporters do not understand is that there is a difference in Good Manufacturing Practices (GMPs) that are required for FDA-registered manufacturers and the legal standards for compounding developed by the United States Pharmacopeia (USP) and the state boards of pharmacy. USP standards are enforceable by both the FDA and the state boards of pharmacy.

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2012 Minnesota Statute on Compounding Drugs: 151.5

2151.15 COMPOUNDING DRUGS UNLAWFUL UNDER CERTAIN CONDITIONS.

Subdivision 1.Location.

 

It shall be unlawful for any person to compound, dispense, vend, or sell drugs, medicines, chemicals, or poisons in any place other than a pharmacy, except as provided in this chapter.

Subd. 2.Proprietors of pharmacies.

 

No proprietor of a pharmacy shall permit the compounding or dispensing of prescriptions except by a pharmacist or by a pharmacist intern under the personal supervision of a pharmacist; or the vending or selling of drugs, medicines, chemicals, or poisons in the proprietor's pharmacy except under the personal supervision of a pharmacist.

Subd. 3.Unlicensed persons; veterinary legend drugs.

 

It shall be unlawful for any person other than a licensed veterinarian or pharmacist to compound or dispense veterinary legend drugs except as provided in this chapter.

Subd. 4.Unlicensed persons; legend drugs.

 

It shall be unlawful for any person other than a licensed practitioner or pharmacist to compound or dispense legend drugs except as provided in this chapter.

History: 

(5808-16) 1937 c 354 s 16; 1967 c 377 s 3; 1986 c 444; 1988 c 550 s 10; 1990 c 526 s 4; 1991 c 213 s 2; 1994 c 632 art 2 s 3
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One View--Regulate Compound Pharmacies With Care

From The Free Press, Mankato, MN

October 30, 2012

Our view: Regulate compound pharmacies with care

— So far, 24 people who have died of fungal meningitis after they were injected with tainted steroids made at a compounding pharmacy in Massachusetts. Another 328 people in 18 states have fallen ill, including nine in Minnesota.

What those patients didn’t know is that the pharmacy that made the steroids and others like it have been largely exempted from Food and Drug Administration oversight.

More FDA oversight in the specialty businesses is needed, but it should be done in a way that does not bring onerous regulation to the many small compounding pharmacies that provide a valuable service for patients and doctors.

Most of the compounding pharmacies are small operations that custom-mix drugs, such as specific compounds to treat children or seniors who can’t easily swallow pills.

The small, specialized industry didn’t come under the same regulation as large drug makers who must ensure they’re operating sterile facilities in a safe manner.

But some compounding pharmacies have grown into mega-drug manufacturers that are pushing the legal limits.

An FDA official warned in 2003 that some large compounders were using “creative marketing” to sell drugs they claimed were superior, without any evidence of support. Still others were manufacturing drugs they claimed were unique, when they were in fact simply cheaper versions of existing drugs.

Regulation of compounding pharmacies has been left to the states, with some assuming that role well while others are unprepared to provide real oversight.       

Congress will need to find ways to rein in so-called compounding pharmacies that are operating in an unsafe manner. But they and the FDA must also be careful not to put needless and costly regulations on legitimate smaller operations.

Source found here