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

Compounding pharmacies have long evaded the tight oversight governing established drug makers Mass. congressman seeks tougher rules for compounders

Lawmakers’ calls for tougher regulation of compounding pharmacies are nothing new. Over decades, there have been a series of attempts at the federal level to rein in a business that has largely evaded the kind of stringent oversight established drug makers face. 

Read full Boston Globe article here

K-V Pharmaceutical Seeks Extension to File Chapter 11 Plan

By Joseph Checkler 
 

K-V Pharmaceutical Co. (KVPBQ) wants to extend the amount of time it can control its own bankruptcy case without the threat of rival proposals, as the company continues trying to sort out issues regarding its flagship premature birth drug, Makena.

In a Friday filing with the U.S. Bankruptcy Court in Manhattan, K-V said it wants until March 4, to file a plan of reorganization without the threat of competing proposals and until May 2, to solicit votes on that plan. Without court approval, the company's right to file the plan and seek the votes would expire on Dec. 3 and Jan. 31, respectively.

"The purpose of the Debtors' present request for an extension of the Exclusive Periods is, among other things, to ensure that the Debtors have an opportunity to seek to address the concerns of all stakeholders," K-V said in its filing.

K-V's bankruptcy, like its business before it filed for Chapter 11, centers on the success of Makena. K-V bought the rights to Makena from Hologic Inc. (HOLX) in a deal that closed last year. Hologic, which K-V still owes money tied to Makena, is trying to get the rights to the drug back. It claims that K-V has made missteps that have sapped value out of the drug.

When Makena hit the market, K-V sold it for $1,500 per shot, a price that set off protests from detractors who said the drug was too costly. The Food and Drug Administration then decided not to take action against "compounder" companies making cheaper drugs using the same active ingredient as Makena, which hurt the drug's sales. K-V eventually lowered the price.

Although the FDA clarified its statement about Makena in June, the company thought it didn't go far enough and sued. A judge threw out the initial lawsuit, though K-V could appeal.

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