PHARMACY

FDA cites Ranbaxy plant for possible violations

BY Alaric DeArment

GURGAON, India — The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

Ranbaxy said it received a Form 483 from the FDA, a statement issued to a company’s management after it has inspected a plant and found conditions that may violate the agency’s regulations, and that products produced therein could be hazardous to people who use them. The plant in question is in Toansa, in India’s Punjab region.

"Ranbaxy continues to improve its systems and processes and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company," a statement from the drug maker read. "Ranbaxy stays firmly committed to its philosophy of ‘Quality and Patients First.’"

In September, the FDA barred importation of drugs from the company’s plant in Mohali, also in Punjab, through an import alert, meaning customs officials can seize drugs from the plant when they reach the U.S. border. The agency said the alert would remain in effect until Ranbaxy complied with the FDA’s current good manufacturing practices, or CGMP. Two other Ranbaxy plans in India, Paonta Sahib and Dewas, have been under import alerts since 2008.

 

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Reports: Mich. governor signs bill allowing medical marijuana at pharmacies, conditional on federal approval

BY Alaric DeArment

NEW YORK — Gov. Rick Snyder of Michigan has signed into law a bill that will allow medical marijuana to be sold in pharmacies if the federal government legalizes it for that purpose, according to published reports.

As 2013 drew to an end, both houses of Michigan’s state legislature passed a bill that would allow pharmacies to sell medical marijuana, but only if the federal government allows it. Currently, the Drug Enforcement Administration classifies marijuana as a Schedule I controlled substance, meaning it is an illegal drug with no officially recognized medical purpose. Nevertheless, 21 states and the District of Columbia have laws allowing it for medical purposes, while Colorado and Washington have legalized it for recreational use as well.

Legalization of the federal level would address the precarious legal limbo in which legal medical marijuana dispensaries dwell. A New York Times report published Saturday examined one major issue that dispensaries face, which is how to handle money. The dispensaries are forced to store their money in cash on the premises and also do all their business in cash, as banks — even state-chartered ones — generally refuse to give them accounts for fear of being accused by the federal government of money laundering, thus making it difficult for the dispensaries to accept credit cards.

 

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Reports: N.Y. governor issues executive order allowing medical marijuana

BY Alaric DeArment

NEW YORK — New York state has begun to legalize medical use of marijuana, albeit in limited form, according to published reports.

Currently, 20 states and the District of Columbia allow the dispensing of marijuana for medical use, two of which — Colorado and Washington — have legalized recreational use, while Maryland allows medical use as a legal defense in criminal cases.

The New York provision, an executive order by Gov. Andrew Cuomo, would allow prescribing of medical marijuana at up to 20 hospitals in the state, making its scope far more limited than in other states, where medical marijuana is allowed under statutory law and is usually sold in special dispensaries, according to reports. The New York Times reported that Cuomo would use the Antonio G. Olivieri Controlled Substance Therapeutic Research Program, which allows such medical conditions as cancer and glaucoma to be treated using controlled substances.

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