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Editorial: Repackaging Nonsterile Products, Part 2
Regarding nonsterile repackaging activities, last week we looked at the basis for repackaging in pharmacy practice and some applicable definitions (dispenser, repackaging, repackager). This week we will look at the emphasis on the first three of the following repackaging chapters within the USP:
| <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 |
USP <681>
This chapter is "to provide guidance to those engaged in pharmaceutical dispensing, not commercial repackaging." It discusses labeling, storage, reprocessing, and customized patient medication packages (patient med paks). It also discusses the beyond-use dates to be assigned since the expiration date in the original manufacturer's container-closure system is not applicable to a repackaged product
USP <1079>
This chapter provides good storage and distribution practices to ensure that drug products reach the end user unchanged and maintaining their original quality characteristics. It discusses storage and distribution for the entire distribution chain, including the dispensing function. The reason it is included in this series is that repackaging operations (repackagers) are discussed where the drug product may be owned by an organization other than the primary manufacturer.
USP <1136>
This chapter provides guidance for unit-of-use packaging to manufacturers, repackagers, and pharmacists. The unit-of-use container is one that contains a specific quantity of a drug product that is intended to be dispensed as such without further modification except for the addition of appropriate labeling. It may be a multiple container or a single-unit container. The chapter discusses the types of containers for unit-of-use (single-unit, unit-dose, single-dose, and multiple-unit), packaging fabrication materials (glass, plastic), packaging closure types (reclosables, nonreclosables), labeling, repackaging and processing, information from manufacturers, responsibility of the dispenser (labeling, information to patient), and quality control of packaging system.
We will conclude this series next week and then point out some interesting parts of these chapters as they relate to expiration dates the following week.
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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Antiseptic Skin Prep Sterility Questioned
The FDA is now considering whether antiseptic skin prep products should be required to be sterile. They will discuss ways to reduce potentially dangerous bacteria in antiseptic wipes, swabs, pads, and solutions, which have been linked to massive product recalls—and infections blamed for illness and death.
Currently, the prep products used to swab the skin before injections or surgeries are not required to be sterile. In the 1970s, experts thought the antiseptic solutions were strong enough to kill any bacteria, but recent reports of contamination in widely used antiseptics have raised new worries.
http://vitals.nbcnews.com/_news/2012/12/05/15702729-bacteria-in-antiseptic-skin-prep-fda-ponders-sterility?lite
Off-label Use Promotion Ruled as Free Speech
The conviction of a sales representative for promoting off-label use of a prescription drug was overruled by the 2nd U.S. Circuit Court of Appeals in New York, making it harder for the government to police how drugs are marketed and sold. The court said that the sales representative's free speech rights under the First Amendment had been violated. The decision overturned the October 2008 conviction of the sales representative.
Many large healthcare settlements with the U.S. government have involved off-label promotions, including GlaxoSmithKline Plc.'s $3 billion and Pfizer Inc.'s $2.3 billion accord in 2009.
http://www.reuters.com/article/2012/12/04/us-offlabel-conviction-idUSBRE8B21DC20121204
New Massachusetts Regulations Slammed by Pharmacy Representatives
Several of the new Massachusetts regulations are ambiguous and overreaching, industry advocates charged. They state that the deadly meningitis outbreak behind the new crackdown could have been prevented if the state's pharmacy board had only enforced its existing regulations.
"The regulations in Massachusetts were stricter than in most states...It doesn't matter what regulations you have, if they are not enforced, it doesn't mean anything," Todd Brown, executive director of the Massachusetts Independent Pharmacists Association said after testifying before the state board today that governs pharmacies.
"Both the FDA and the Board of Pharmacy had the opportunity to go into the New England Compounding Center, inspect it and shut it down based on the violations of existing regulations. But unfortunately, in both those instances it did not happen," he added.
http://bostonherald.com/news/regional/view/20221204pharmacy_representatives_
slam_states_new_emergency_regulations
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Essentials of Pharmacy Management
2nd Edition
Tootelian DH, Wertheimer AI, Mikhailitchenko A.
Pharmaceutical Press; October 2012; 464 pages; $65.00
With authors from two Colleges of Business Administration and one from a College of Pharmacy, this is a good volume to read prior to jumping into management in an increasingly business-oriented environment. Its 17 chapters are divided into six parts: (1) Pharmacy practice in perspective, (2) Planning and risk management, (3) Accounting and financial management, (4) Marketing strategies, (5) Organization and staffing the pharmacy, and (6) Pharmacy operations management. The text focuses on the basics of good business practice and includes cases that allow application of what has been learned in the chapters to business situations in the context of diverse practice settings. A really good book to read!
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