It's all in the wrist package!

From the USP:

• Packaging must not interact physically or chemically with official articles in any way that causes their safety, identity, strength, quality, or purity to fail to conform to requirements.
• The packaging system (also referred to as a container-closure system) is the sum of packaging components that together contain and protect the article.

We are all familiar with recent announcements of the syringe companies that their syringes were not developed for long-term storage of medications. A recent FDA release (Posted 08/18/2015) is entitled "Compounded or Repackaged Drugs Stored in Becton-Dickinson (BD) 3 mL and 5 mL Syringes: FDA Alert—Do Not Use Unless There Is No Suitable Alternative."

The notice states "Hospital and pharmacy staff should check supply stocks and remove drug products that were filled by pharmacies or outsourcing facilities and stored in general purpose BD 3 mL and 5 mL syringes."

NOTE: This doesn't state, but I assume, it also applies to hospital pharmacies that prepackage drugs in syringes for later use.

It has been well-known for years that some drugs will "sorb" to plastic containers, especially soft plastic IV bags, etc. It has also been known that some will "sorb" to syringes/plunger tips. This is especially critical in high-potency, low-concentration drugs but not as critical in drugs in high concentration. There are many published studies that address this clinical pharmaceutics situation.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Generic Delalutin by McGuff Approved by the FDA
The FDA has approved McGuff Pharmaceuticals' ANDA for hydroxyprogesterone caproate injection USP, 250 mg/mL, the generic equivalent to Delalutin Injection, 250 mg/mL formerly produced by Bristol-Myers Squibb. AMAG Pharmaceuticals also markets the same injection, 250 mg/mL, under the brand name Makena.
http://seekingalpha.com/news/2812706-fda-clears-mcguff-pharmas-generic-delalutin-injection

Baxter Recalling More Saline�Potential Mold Contamination
Sodium chloride injection availability is taking another hit as Baxter recalls yet more sodium chloride: nearly 140,000 bags more because of the possibility that some bags have mold in them. It is recalling its 100-mL minibag Viaflex containers of 0.9% sodium chloride injection after receiving a complaint of mold on the interior surface of an overpouch. The product was made at a Baxter plant in Jayuya, Puerto Rico; the plant received an FDA warning letter two years ago for a number of problems including 20 nonconformance reports on liquid products containing everything from skin to human hair to rayon.
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1816-2015&w=09302015⟨=eng

Rust in Vials Causes Hospira Recalls of More Lidocaine with Rust
Last spring Hospira recalled a lot of lidocaine, saying particles of iron oxide had been spotted in some vials; they have added another 100,200 vials to its recall for the same reason. In recent years, Hospira has led in U.S. recalls of drugs, including nearly 40 million vials of ketorolac tromethamine, 314,600 bags of 0.9% sodium chloride, and 126,075 vials of propofol. It also recalled 181,704 bags of magnesium sulfate in 5% dextrose that potentially bore labels indicating they were the blood thinner heparin.
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1815-2015&w=09302015⟨=eng

Drug Products Recalled by Park Compounding Pharmacy Due to Lack of Sterility Assurance
The FDA's recent inspection of Park Compounding Pharmacy's facility in Westlake Village, California revealed unsanitary conditions, including poor sterile-production practices, which raised concerns about the company's ability to assure the sterility of drug products that it produces. The FDA recommended that Park Compounding Pharmacy cease sterile operations until adequate corrections are made at its facility, and recall all of its non-expired sterile-drug products. The FDA is not aware of any adverse events associated with this recall to date.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor
HumanMedicalProducts/ucm465582.htm

PharMEDium Acquired by AmerisourceBergen
AmerisourceBergen has announced that it has signed a definitive agreement to purchase PharMEDium Healthcare Holdings, Inc., the privately held leading national provider of outsourced compounded sterile preparations (CSPs) to acute care hospitals in the U.S. for $2.575 billion in cash, subject to certain adjustments and on a cash-free, debt-free basis. PharMEDium is the largest provider of customized outsourced CSPs that meet specific hospital and physician clinical needs and quality standards in formulations that are not otherwise commercially available.
http://www.fiercepharmamanufacturing.com/press-releases/amerisourcebergen-acquire-pharmedium-healthcare-holdings-inc?utm_medium=nl&utm_source=internal

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Did You Know ...

�that Monday is "Columbus Day"?

Tip of the Week

Did Columbus stop and ask directions? Many countries in the New World and elsewhere officially celebrate Columbus Day as a holiday on the anniversary of Christopher Columbus' arrival in the Americas, which occurred on October 12, 1492. Since 1970 (October 12), the holiday has been fixed to the second Monday in October.

Looking Back

HIS face was loved,
By just his mother,
He Burma-Shaved,
And now-Oh, brother!
     Burma Shave