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Editorial: Repackaging Nonsterile Products, Part 3
Regarding nonsterile repackaging activities, this week we will complete our review of the USP General Chapters related to the repackaging of nonsterile products. This week we will look at the emphasis on the last two of the following chapters.
| <681> | | Repackaging into Single-unit Containers and Unit-dose Containers for Nonsterile Solid and Liquid Dosage Forms |
| <1079> | | Good Storage and Distribution Practices for Drug Products |
| <1136> | | Packaging—Unit-of-Use |
| <1146> | | Packaging Practice—Repackaging a Single Solid Oral Drug Product into a Unit-dose Container |
| <1178> | | Good Repackaging Practices |
<1146>
This chapter applies to the repackaging of solid oral products, such as tablets and capsules, into unit-dose packaging and applies to both the pharmacists and to repackaging firms. Following the introduction and definitions, the chapter discusses the materials and design of different blister-type unit-dose packaging systems. It then discusses the performance requirements of the systems, the beyond-use dates that can be applied and then requirements for personnel, facility, equipment, process, labeling, materials, storage, drug product, complaints, returned goods, reprocessing, and special considerations (oxygen, moisture, light sensitivity).
<1178>
This chapter is not intended for pharmacists engaged in dispensing prescription drugs in accordance with a state practice of pharmacy; it is intended to provide guidance to those engaged in repackaging of oral-solid drug products. It defines a repackager and a contract packager as well as an equivalent container-closure system. The emphasis on this chapter appears to be the establishment of the expiration date for unit-dose and multiple-unit packaging.
Next week, some interesting items regarding these chapters and beyond-use-dates will be highlighted.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy
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Drug Shortages Increase Post-meningitis Situation
The FDA's critical drug shortage list contains six products formerly supplied by NECC. These drug shortages are increasing in some parts of the nation, as many hospitals and other medical centers relied on the companies. These facilities are now scrambling to identify new sources for drugs, including antibiotics, lifesaving medicine, and pain medications. In 2012, the FDA has listed more than 100 drugs in short supply in the U.S. The six products on the critical shortage list include sodium bicarbonate injection, succinylcholine injection, atropine sulfate injection, bupivacaine hydrochloride injection, lidocaine hydrochloride injection, and furosemide injection.
http://www.ama-assn.org/amednews/2012/12/10/hlsa1210.htm#top
Servier Founder in France Being Investigated in Drug Deaths
A Paris court has formally placed the founder of French drugmaker Servier under investigation on suspicion of manslaughter for his role in the Mediator anti-diabetes drug scandal. French officials blamed at least 500 deaths on the drug that was often prescribed for weight loss before being pulled from the French market in 2009, about a decade after its withdrawal from Spain, Italy, and the U.S.
http://www.reuters.com/article/2012/12/11/france-mediator-idUSL5E8NBGI520121211
Porcupine Quills and Injections?
Porcupine quills can easily penetrate human flesh but are difficult to remove due to microscopic barbs. Researchers studied the structures to understand how they effortlessly enter flesh but do not leave as smoothly. Their ease of penetration appears to be due to the presence of the barb, as it appears to significantly reduce the penetration force required. The barbs have been compared to serrated knife blades that localize the penetration force at the tip of the teeth rather than along the length of the blade. The analogy used is that of slicing a tomato—it is much easier to slide with a serrated versus non-serrated knife, and use of a serrated knife imposes less damage. They found that the quills required 60% to 70% less force to penetrate muscle tissue than quills without barbs.
http://www.bbc.co.uk/nature/20628302
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