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Drug Quality and Security Act Signed – Will it Pass?

DQSA passes SenateThe healthcare industry remains in the spot light focusing on increased patient safety and controlling escalating associated costs.

On November 18, 2013, the U.S. Senate approved the Drug Quality and Security Act (H.R. 3204), which will create a national set of standards to track pharmaceuticals through the distribution chain to help prevent the introduction of fake medications into the drug supply.

This bill is intended to modify the Federal Food, Drug and Cosmetic Act to allow the FDA to regulate the manufacturing of compounded drugs. Compounding is the creation of a particular pharmaceutical product to fit the unique need of a patient.

This bill was introduced after 64 people were killed and another 750 were infected  by a meningitis outbreak linked to the New England Compounding Center in Framingham, Massachusetts in 2012.

If passed this law exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements.

It is now up to President Obama to sign this bill.

Being in the labeling and barcode business, we see how challenging some things are to be positively identified through its intended lifecycle and used for tracking or traceability.  For example: items that look alike, others that require sterilization, lots/batches that may be traced back to the manufacturer in an adverse event, expiration dates, etc. all have their own label or direct mark requirements. The new FDA’s UDI rule is an example of a global and unique identification system in the healthcare industry to protect patient safety, create traceability from manufacturing to end use, and improve operations such as inventory control.

Do you know if your business will be affected? Will you know what to do if this rule passes?

We work with various industry compliance mandates and help our customers get in to compliance. If you need answers to compliance labeling, direct marking, or other identification questions, give David Holliday a call at 603-598-1553 x237 or use our contact form.

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