If you’re in the pharmaceutical industry then you know the importance of keeping an eye on compliance for the storage of your prescription drug samples. Finding business storage that meets both the compliance and budget can be a hard feat. Keep these tips in mind while you’re on the hunt:
The Food and Drug administration mandates that storage of your prescription drug samples fall in line with the Prescription Drug Marketing Act. The list below will spell out 21 CFR Parts 203 and 205 of this act. With these parts in mind, you will want to be sure that the storage unit you choose is up to par with these regulations. Keep these three specific regulations in mind and ask yourself these questions when choosing a storage unit for your drug samples:
1. Security – To provide “suitable protection against theft and diversion.” [21 CFR 205.50(b)]
- Is this storage facility safe? When you’re on the storage hunt for your prescription samples, does the facility in question offer any type of security? This can be an on-site security guard, alarm system, key-codes or a 24-hour surveillance system. You’ll want a facility that can offer assurance that your samples are protected against theft, diversion and counterfeiting.
2. Climate Control – To “store and handle all drug samples under conditions that will maintain their stability, integrity, and effectiveness, and ensure that the drugs are free of contamination, deterioration, and adulteration.” [21 CFR 203.32 & 205.50(c)]
- Will your samples maintain their stability? Prescription drug samples are temperature- sensitive! For optimum compliance, your samples will need cooling in the summer and heating in the winter. Confirm that your storage facility offers climate controlled units.
3. Auditing, Inventory Control & Record Keeping – To conduct “random and for-cause audits of sales representatives by personnel independent of the sales force …” [21 CFR 203.34(B)(3)] and To “maintain a list of the names and addresses of representatives who distribute drug samples and of the sites where drug samples are stored.” [21 CFR 203.31(e)]
- How will you maintain inventory and record keeping control in case of an audit? Some companies will offer a business storage program to help manage your storage units. These storage programs provide day-to-day management of your storage units such as room searches, reservations, billing inquiries or tracking move-in and move-outs.
What has been your experience with finding pharmaceutical storage? Share your tips and suggestions in the comment section below: