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Editorial: Repackaging Sterile Products
The USP has a number of General Chapters on repackaging of nonsterile products but does not have one specifically on repackaging sterile products. However, it does fit in USP <797> Pharmaceutical Compounding—Sterile Preparations as follows, so this activity must be done under USP <797> compliant standards:
<797> Pharmaceutical Compounding—Sterile Preparations
*Low-Risk Level CSPs:
2. The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or package of sterile product or administration container/device to prepare the CSP.
3. Manipulations are limited to aseptically opening ampuls, penetrating disinfected stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
<797> Examples of Low-Risk Compounding-
1. Single-volume transfers of sterile dosage forms from ampuls, bottles, bags, and vials using sterile syringes with sterile needles, other administration devices, and other sterile containers�
From #2 above, low-risk level CSPs involve "not more than three," which includes one, two or three commercially manufactured packages. Use of "one" could include removal of a portion of the contents of a commercial package, as in repackaging.
From #3 above, the manipulations include removing from one container and transferring the sterile liquid using sterile syringes to a second container or device, as in repackaging.
Other general chapters where repackaging is addressed include the following:
- <1146>: Repackaging is the act of removing a preparation from its original primary container and placing it into another primary container, usually of smaller size.
- <1163> discusses repackaging.
- <1191> states "Pharmacists help to ensure that the products under their supervision meet acceptable criteria of stability by�(4) properly treating and labeling products that are repackaged, diluted, or mixed with other products."
And
- "�if a sterile product is repackaged from a multiple-dose vial into unit-dose (disposable) syringes, discard the latter if not used within 24 hours, unless data are available to support longer storage."
The very diverse topic of repackaging will be covered in more detail in future issues of the International Journal of Pharmaceutical Compounding, starting with the January/February 2013 issue.
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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Head of Massachusetts Pharmacy Board Fired
The Massachusetts' health department has fired the director of its pharmacy board, after he failed earlier this year to investigate a complaint about the NECC. James Coffey, former director of the Massachusetts Board of Pharmacy, failed to follow up on a complaint from the Colorado pharmacy board accusing NECC of illegally selling pharmaceuticals without a prescription.
Last year, the Colorado pharmacy board, after investigating NECC's sales to hospitals in Colorado, issued a "cease and desist" order to NECC. Also, a Colorado inspector sent the order as well as other materials to Mr. Coffey, who pledged to follow up.
The Massachusetts health department's interim commissioner said that it was "incomprehensible" that Mr. Coffey didn't follow up on Colorado's complaint given previous concerns raised about NECC's and the board's responsibility to investigate complaints.
http://online.wsj.com/article/SB10001424127887324073504578105412195419472.html?mod=dist_smartbrief
Substandard Drugs Rampant in India
The sale of substandard drugs involving India is on the rise. The quantity of such drugs has increased voluminously when compared to the figure in 2011. Although they have enforcement procedures in place at all points of sale, wholesale dealers and drug stores continue to sell it without any restriction. They have been strictly monitoring the sale of such drugs.
http://articles.timesofindia.indiatimes.com/2012-11-05/kochi/34926188_1_substandard-drugs-drugs-control-erectile-dysfunction
Drug Companies Cutting Jobs
The parade of drug company layoffs continues, as summarized below:
- Bristol-Myers Squibb plans to eliminate 479 sales reps and related jobs
- Pfizer is cutting 300 jobs in Quebec
- J&J has eliminated 130 jobs
- Teva Pharmaceuticals cut 65 jobs at its California plant
- Abbott Laboratories axed 550
- Merck cuts 150 jobs as part of an ongoing restructuring
- AstraZeneca eliminated 260 positions from its MedImmune unit
http://www.pharmalot.com/2012/11/the-axe-falls-bristol-myers-to-cut-nearly-500-jobs/
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