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FDA says things haven't changed.
They have been a long time coming, but the regulations implementing the Prescription Drug Marketing Act of 1987 were finally published in the Federal Register (vol. 64, no. 232) (draft regulations were published in the March 14, 1994 Federal Register). However, the delay between the passing of the statute and the publication of the regulations, caused by the implementation of the Food and Drug Administration Modernization Act, has led some pharmaceutical reps to believe that a whole new set of requirements has been published - particularly with regard to sample storage.
"In terms of specific sample storage, [the regulation] repeats what the statute says, which is that samples are to be stored according to their labeling requirements or the USP requirements, if the drug is USP," said Margaret O'Rourke, Prescription Drug Marketing Act senior regulatory expert for the FDA's Center for Drug Evaluation and Research.
In other words, with regard to sample storage, nothing has changed in the last 10 years.
That isn't to say, however, that reps can breath easy about storing their samples wherever they find convenient. Although the statute isn't specific about where samples must be stored, label storage requirements must still be strictly adhered to. "That usually requires that [samples] would be stored at controlled room temperature, which means thermostatic control, not just ambient temperature," said O'Rourke. "We haven't pursued it down to the level of individual representatives or storage units up to this time."
This means it's up to individual representatives and their employers to determine their sample storage needs, which vary widely between reps in different locations. For example, a representative in Arizona might want to think twice about storing samples in the trunk of his or her car all day or keeping extra samples in a garage that isn't temperature-controlled.
For representatives who want to stay on the safe side of the regulations, climate-controlled storage facilities may be an option. Climate-controlled storage facilities offer much more protection from the whims of Mother Nature than a standard storage unit.
"A standard storage unit would be like storing it in a detached garage, where there is no insulation at all, so it is shielded from the wind and the rain, that's it," said Robert Soudan Jr., co-owner of the Northfield, IL-based storage company Lock Up Development Corp. "In cases where it's climate-controlled, the majority of those units â especially the ones pharmaceutical reps use â are interior, which means that they would pull their vehicle in and the door shuts behind them, and if it's blowing or raining outside, they're totally inside. So they can load and unload their stuff onto pushcarts, and roll them down the hallway to their unit and it's temperature-, humidity-controlled."
According to Soudan, who said that up to 10% of Lock Up's total business comes from pharmaceutical sales representatives, the units are not individually temperature- and humidity-controlled; however, Lock Up keeps the building the units are contained in at about 73 degrees in the summer and 65 degrees in the winter.
The cost of climate-controlled storage differs by geographic region, according to Soudan, but reps can generally expect to pay between 20% and 40% more for a climate-controlled unit.
The extra costs may be worth it. While the wording in the regulations is general right now, the Food and Drug Administration said it would consider altering the regulations if it received reports that problems were being found with drug samples distributed to licensed practitioners.
"The drugs that are being sampled have undergone rigorous stability testing," said O' Rourke. "However, some drugs are more sensitive than others to environmental factors such as heat, light and moisture. Sampling of such drugs, if done at all, should ensure that the storage conditions these drugs are exposed to are within requirements. We are interested in determining whether a firm has written standards and maintains controls over how their representatives store their samples. If problems are found with sample storage, we could pursue regulatory action based on the storage requirements contained in the PDMA and the final regulations." PR