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Editorial: Documentation vs Opinion on Compounding Regulatory Activities II

This series looks at some of the 483 observations and Board of Pharmacy activities and tries to provide documentation surrounding these specific activities.

Observation: The pharmacy does not sterility test each compounded preparation.

United States Pharmacopeia (USP) Standards:

<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS

STABILITY CRITERIA AND BEYOND-USE DATING
General Guidelines for Assigning Beyond-Use Dates

"In the absence of stability information that is applicable to a specific drug and preparation, the following table presents maximum [beyond-use dates] BUDs recommended for (1) Nonsterile compounded drug preparations that are packaged in tight, light-resistant containers and stored at controlled room temperature, unless otherwise indicated; and for (2) sterile preparations for which a program of sterility testing is in place."

"When high-risk level CSPs are dispensed before receiving the results of their sterility tests, there shall be a written procedure requiring daily observation of the incubating test specimens and immediate recall of the dispensed CSPs when there is any evidence of microbial growth in the test specimens."

<797> PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS

FINISHED PREPARATION RELEASE CHECKS AND TESTS
High-Risk Level CSPs

"For a sterilized high-risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the [compounded sterile preparations] CSPs are properly stored and are exposed for not more than 24 hours at controlled room temperature, for not more than 3 days at a cold temperature, and for 45 days in solid frozen state between -25� and -10�. [NOTE: Sterility tests for autoclaved CSPs are not required unless they are prepared in batches of more than 25 units.]"

VERIFICATION OF COMPOUNDING ACCURACY AND STERILITY
Sterilization Methods

"The licensed healthcare professionals who supervise compounding shall be responsible for determining that the selected sterilization method both sterilizes and maintains the strength, purity, quality, and packaging integrity of CSPs. The selected sterilization process is obtained from experience and appropriate information sources—and, preferably, verified wherever possible-to achieve sterility in the particular CSPs."

FINISHED PREPARATION RELEASE CHECKS AND TESTS
Sterility Testing

"All high-risk level CSPs that are prepared in groups of more than 25 identical individual single-dose packages (e.g., ampuls, bags, syringes, vials) or in multiple-dose vials (MDVs) for administration to multiple patients or that are exposed longer than 12 hours at 2� to 8� and longer than 6 hours at warmer than 8� before they are sterilized shall meet the sterility test (see Sterility Tests <71> before they are dispensed or administered)."

<71> STERILITY TESTS

TEST FOR STERILITY OF THE PRODUCT TO BE EXAMINED
Number of Articles to be Tested

"Unless otherwise specified elsewhere in this chapter or in the individual monograph, test the number of articles specified in Table 3."

Comment:

1. The statement in USP <795>, item (2), states that the BUDs listed can be used if a "program of sterility testing is in place." This does not state that every compounded preparation must be sterility tested but that a "program" of sterility testing must be in place. A program, or "plan of procedure," or "SOP" does not require that every single preparation be tested but that a plan be in place for what is tested and how frequently the testing must be done.
2. The verification paragraph above states that the sterilization method used must be selected based upon experience and appropriate information sources; preferably, it should be verified wherever possible to achieve sterility in the particular CSPs being compounded.
3. In USP <797>, it is clear that batches greater than 25 identical individual units (single- or multiple-dose) must be sterility tested.
4. In USP <71>, it appears that the minimum number required for testing is 4, unless the volume in each is insufficient for the tests where the number will be increased to 8. If one is compounding less than 4 vials, it does not meet the requirements of this chapter. It is impractical in many cases to prepare additional vials to bring the number up to the minimum required for this chapter. For example, it is not feasible to prepare five vials so one can be dispensed and four can be used for sterility testing. One must remember that most of the chapters in the USP General Chapters were designed, developed, and written for the pharmaceutical industry, where large volumes are prepared, not for compounding where only a few may be prepared.

Summary: From the above, it appears that not every CSP must be sterility tested, but that a program of sterility testing is acceptable, except in identical units of 25 or more where sterility testing is required.


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

Pfizer to Sell Viagra Direct to Patients
For the first time in the drug industry, Pfizer Inc. will begin selling Viagra directly to patients on its website. It will still require a prescription, but they no longer have to face a pharmacist to get it filled. If the price of $25 per tablet seems excessive, Pfizer is offering three free tablets with the first order and 30% off the second one. Other pharmaceutical manufacturers will probably watch Pfizer's move closely and, if it works, could begin selling other medicines that are rampantly counterfeited and sold online, particularly treatments for non-urgent conditions seen as embarrassing, including examples such as diet medications, medicines for baldness, and birth control pills.
http://www.washingtonpost.com/business/pfizer-sells-viagra-on-its-website-in-a-drug-industry-first/2013/05/06/80382cc4-b61b-11e2-b568-6917f6ac6d9d_story.html

371 Tons of Prescription Drugs Collected
The American public handed over 371 tons of prescription drugs to the government this past weekend; the DEA collected the unused, expired, and unwanted pharmaceuticals, equal to about nine tractor-trailer trucks, from more than 5,800 nationwide locations as part of its sixth scheduled National Prescription Drug Take-Back Day. The haul collected 50% more than the previous event.
http://thehill.com/blogs/regwatch/healthcare/297465-public-hands-in-371-tons-of-prescription-drugs

Georgia Law to Control "Pill Mills"
Georgia will soon start requiring pain clinics to be licensed by its medical board and owned by physicians. These moves are targeted at slowing the flow of illicit prescription-drug sales in the state. Pain clinics will be required to register every two years, and, if they don't, their owners could face felony indictments. Additionally, the state's medical board could deny licensing to a pain clinic for a variety of reasons, such as an owner's prior criminal conviction related to controlled substances. Georgia will become the ninth state that requires that pain clinics be owned by a physician.
http://online.wsj.com/article/SB10001424127887324582004578459072216867816.html?cb=logged0.4617004797545966

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Should we not celebrate every day as Mothers Day and Fathers Day? If it wasn't for them, we would not be here!

The wolf is shaved,
So neat and trim,
Red Riding Hood,
Is chasing him!
      Burma Shave