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BACKGROUND
What is the role of drug packaging or container-closure (CC) systems? This includes packaging for nonsterile and sterile, solids, semisolids, liquids etc. What are the United States Pharmacopeia (USP) standards/specifications for CC systems and how do they impact the expiration and beyond-use dates (BUDs) for pharmaceuticals?
A drug product may be involved in multiple CC systems in its "life." For example, in each of the steps below, a different container-closure may be involved:
Manufactured Products
| CC #1 | CC #2 | CC #3 | CC #4 |
| Bulk Materials → | Mfg'd Product → | Repkg/Distrib Centers → | Patient |
Compounded Preparations
| CC #1 | CC #2 | CC #3 |
| Bulk Materials → | Compounded Preparation → | Patient |
CC SYSTEM REQUIREMENTS
USP <659> Packaging and Storage Requirements (Official May 1, 2016)
Packaging must not interact physically or chemically with official articles in any way that causes their safety, identity, strength, or purity to fail to conform to requirements.
�For drug products and active pharmaceutical ingredients (APIs), the choices are tight, well-closed, or, where needed, light-resistant. For excipients, given their typical presentation as large-volume commodity items (containers ranging from drums to tank cars), a well-closed container is an appropriate default.
Tight container: A packaging system that protects the contents from contamination by extraneous liquids, solids, or vapors; from loss of the article; and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution and is capable of tight reclosure.
Well-closed container: A packaging system that protects the contents from contamination by extraneous solids and from loss of the article under the ordinary or customary conditions of handling, shipment, storage, and distribution.
COMMENTS
- Packaging (CC system) must maintain the contents in conformance to requirements (i.e., the specifications in the official monographs).
- The CC is useful only during the time period during which the contents are enclosed.
- Once removed, the contents are manufactured, compounded, repackaged, etc., and a new CC is involved with identical requirements of protecting its contents until use.
- The CC system is "neutral" in its relationship with its contents; it does not interact with the contents.
- Containers used in dispensing/compounding must meet the same requirements further detailed in USP <671> Containers-Performance Testing.
- Moving the drug product or ingredient from one appropriate CC system to another should have no effect on the requirement that the contents meet specifications.
- Stability studies establishing BUDs for compounded preparations must use stability-indicating analytical methods that will detect any change in intact drug that may occur regardless of cause, including any interaction with the CC system. The CC systems used in stability studies supporting beyond-use dating must be described in the studies. The CC systems used for the studies must meet USP <659> requirements.
- The requirements/standards for CC systems used in studies and for dispensing to the patient are the same (i.e., maintain the contents in conformance to the specifications in the monographs).
- In summary, the CC system is nonreactive and protective. A drug product is generally involved in two or more CC systems during its manufacturing, compounding, distribution, and dispensing.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
Lobbyists' Battle Cry On Prices: "Blame the Others!"
Recently, hundreds of independent pharmacists swarmed the House and Senate office buildings pitching lawmakers on their plan to rein in the soaring drug prices that have enraged American consumers. They pointed a finger at pharmacy benefit managers like Express Scripts and CVS Health, which handle the drug coverage of millions of Americans. Also involved are brand—name and generic drug makers, and even local pharmacists—with each blaming others for the rising price of medicine. The question remains whether public outrage, political will, and presidential leadership can bring about a meaningful change that will slow the drain on consumers' pocketbooks.
https://www.nytimes.com/2017/05/29/health/drug-lobbyists-battle-cry-over-prices-blame-the-others.html
Children Recruited to Rob Pharmacies
The Mob, according to court documents, committed at least one murder and at least 24 pharmacy robberies throughout the city, terrorizing the north-side neighborhood for years, threatening violence against anyone who talked to the police (calling on them to uphold the "code of silence"). Neighborhood children were recruited by gang members, some as young as 12, to sell the pharmacy drugs they robbed at gunpoint.
Gang members would rob CVS and Walgreen's pharmacies at gunpoint, stealing hundreds of tablets of Adderall, Xanax, Ritalin, OxyContin, and others. They would then sell them on the streets, fueling an opioid epidemic resulting in hundreds of overdose deaths in Indiana. The Mob called the children "peons" and put them to work, writing on social media: "(Expletive) school, sell dope A.S.A.P." In another post, a gang member wrote, "We the murder rate."
Pharmacies have also worked to combat the problem by implementing safes for drugs that open with a time-delay.
http://www.indystar.com/story/news/crime/2017/05/23/feds-say-deadly-gang-recruited-children-rob-pharmacies/339300001/
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