USP Guidance for Repackagers


Erik Swain

There are all kinds of federal regulations governing the original package produced by a pharmaceutical manufacturer. However, most prescription drugs are repackaged at some point in their distribution, and there are few requirements regarding those packages. 

For example, manufacturers must produce precise package specifications, qualify containers, and perform stability tests. Repackagers have no specification requirements and rarely any stability data. Their containers must only meet the United States Pharmacopeia's (USP; Rockville, MD) standard for "tight."

Some in industry believe this dichotomy should change. The USP Packaging, Storage, and Distribution Project Team has identified the repackaging process as a high-risk area of the distribution chain. 

Part of the problem, said Rich Hollander, chair of the USP project team, is that repackagers don't often have access to the packaging data generated by the original manufacturers. Hollander, who is also senior director for packaging services at Pfizer Inc. (New York City), spoke at the Healthcare Compliance Packaging Council's (HCPC; Falls Church, VA) 11th annual symposium on patient compliance, held May 6-7 in Philadelphia. 

"Let's stop playing this game," he said. "Let's recognize that (repackagers) exist and give them some guidance."

If repackagers get better information from the pharmaceutical manufacturers and better guidance from USP and FDA, they should be able to use packages more appropriate for a drug's protective requirements, Hollander said. That means if a manufacturer determines its drug must be packaged in a blister, it should instruct repackagers to repackage it in a blister. 

"I don't want people repackaging my drug into something that's less protective," he said. "It's not good for the patient. So why don't we give that instruction (to the repackager)? Because no one is telling us to do it."

As a result, the task force is recommending improving dissemination of information from manufacturers to repackagers. It is also suggesting USP <671> be expanded to better correlate bottle and blister classifications. To help with the correlation, it is asking USP to consider adopting the moisture vapor transmission rate (MVTR) per unit concept that industry often uses for postapproval change evaluation. 

Hollander also said the project team would like to see USP establish a dialogue with the Consumer Product Safety Commission (CPSC; Washington, DC). This is because "the child-resistant mechanisms used often cause medicines to be stored in a compromised state," especially because some manufacturers find the protocol tests for blisters too difficult.
At the patient level, Hollander said, the project team would like to see USP develop an education program on proper handling and storage of medicines. It should also encourage package formats that facilitate compliance and add a chapter on prescription-container labeling. He said that currently, it may be difficult for patients to differentiate between medications if they have more than five of them in identical-looking prescription vials. 

USP was scheduled to publish the project team's findings in May, and hopes to convene an open meeting on the topic in fall 2003, Hollander said.

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