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Editorial: Repackaging Nonsterile Products
In the previous two issues of this newsletter, we discussed the repackaging of sterile products, using two scenarios, that show that this activity falls under USP <797> Pharmaceutical Compounding—Sterile Preparations. Now we will look at the General Chapters that discuss repackaging of nonsterile products, as contained in the following enforceable and informational chapters:
| <681> | | Repackaging into Single-unit Containers and Unit-dose Containers for Nonsterile Solid and Liquid Dosage Forms |
| <1136> | | Packaging-Unit-of-Use |
| <1079> | | Good Storage and Distribution Practices for Drug Products |
| <1146> | | Packaging Practice-Repackaging a Single Solid Oral Drug Product into a Unit-dose Container |
| <1178> | | Good Repackaging Practices |
There are primarily two entities involved in repackaging nonsterile products: (1) commercial repackaging firms that must be registered, and (2) pharmacies. The latter is the subject of this series. First, a few definitions:
Dispenser (USP <1146>) is a licensed or registered practitioner who is legally responsible for providing a preparation for patient use, with a specific patient label, pursuant to a prescription or a medication order. Dispensers are governed by the board of pharmacy of the individual state.
Repackaging (USP <1146>) is the act of removing a preparation from its original primary container and placing it into another primary container, usually of smaller size.
Repackager (USP <1146>) is an establishment that repackages drugs and sends them to a second location in anticipation of a need. Unlike dispensers, repackaging firms are required to register with the FDA and to comply with the Current Good Manufacturing Practice regulations in 21 CFR 210 and 211.
To provide support for pharmacy repackaging of nonsterile pharmaceuticals, the activity is discussed in the following chapters:
- USP <795> Pharmaceutical Compounding—Nonsterile Preparations, which defines "compounding" as "The preparation, mixing, assembling, altering, packaging and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Later in the chapter it states: "For information on assigning BUDs when repackaging drug products for dispensing or administration, see USP <681>� and USP <1136>�".
- USP <1146> Packaging Practice—Repackaging a Single Solid Oral Drug Product into a Unit-dose Container, in the opening paragraph, states "Repackaging of solid oral drug products, such as tablets and capsules, into unit-dose configurations is common practice both for the pharmacy that is dispensing drugs pursuant to a prescription and for the pharmaceutical repackaging firm.
- USP <1163> Quality Assurance in Pharmaceutical Compounding, when discussing the Quality Assurance program, states �(7) containers, packaging, repackaging, labeling, and storage�".
- USP <1191> Stability Considerations in Dispensing Practice under the responsibility of pharmacists, lists "�(4) properly treating and labeling products that are repackaged, diluted, or mixed with other products�" Also, the chapter states "In repackaging, diluting a product or mixing it with another product, the pharmacist may become responsible for its stability." It also contains a section on "Repackaging"
Next week, we will look at the content of these repackaging chapters in the USP.
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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Judge Allows Civil Suits to Proceed and Sees Potential Criminal Investigation into NECC Pharmacy
A federal judge in Boston is allowing civil suits (about 70) against NECC to proceed and noted that any criminal case would have priority in gathering evidence. There may be a grand jury investigation, and there is certainly a potential criminal investigation overlaid on this. Over 500 people in 19 states were diagnosed with meningitis and 36 have died in the outbreak linked to the NECC.
http://www.reuters.com/article/2012/11/28/usa-health-meningitis-court-idUSL1E8MS3ON20121128
Fungal Infections Reach 510
The number of individuals diagnosed with meningitis has risen to 510 with 36 deaths, the U.S. Centers for Disease Control and Prevention has announced. Almost all the illnesses are classified as fungal meningitis, strokes related to that disease or other infections of the central nervous system; others include peripheral joint infections of the knee, hip, shoulder, or elbow.
This week, the Tennessee Health Department will begin the task of recontacting the more than 1,000 people exposed to the contaminated, preservative-free methylprednisolone acetate, produced by New England Compounding Center, which is under criminal investigation in Massachusetts and an ongoing probe by federal and state health officials. These contacts are because the latest wave of infections is different from the first meningitis cases.
http://www.tennessean.com/article/20121126/NEWS07/311260056/Meningitis-outbreak-Fungal-infections-reach-510-nationwide
Judge Orders Tobacco Companies to Admit Deception
Major tobacco companies that have lied for decades to the U.S. public about the dangers of cigarettes must spend their own money on a public advertising campaign explaining that they did lie, a federal judge ruled. This may be the harshest sanction to come out of a historic case that the Justice Department brought in 1999 accusing the tobacco companies of racketeering. U.S. District Judge Gladys Kessler wrote that the punishment would be an appropriate counterweight to the companies' "past deception" dating to at least 1964. The advertisements are to be published in various media for as long as two years.
http://www.reuters.com/article/2012/11/28/us-usa-tobacco-idUSBRE8AQ18A20121128
(Editor's Note: It is interesting that a federal judge can require someone to admit they lied but politicians and federal employees can lie with apparently no requirement to admit it!)
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