Simple Weights and Simple Weighing

Weighing is probably the simplest quality assurance method available in a compounding pharmacy, regardless of the setting. Two basic types of weights for quality assurance are important; first, the total weight of a prescription should match what is being compounded, and second, in many cases, each individual dosage unit can be weighed to document it is in conformance with USP compounding standards (±10% of the target value unless there is an official monograph for that specific preparation). See USP Chapter <795>.

Total prescription weight is appropriate for bulk powders, ointments, gels, creams, and pastes, as well as some solutions, suspensions, and emulsions that might be prepared by weight. Weighing individual dosage units is suitable for capsules, tablets, lozenges/troches, suppositories, sticks, solid implants, etc.

Weighing can be easily accomplished by calibration of the balance, taring the balance with a weighing paper or weigh boat, and calculating the target value with the acceptable low and high cutoffs. Next, each capsule, tablet, lozenge/troche, suppository, etc. can simply be individually placed on the balance and the weight recorded manually or into a compounding software system that is connected to the balance (or printed if a printer is attached). This becomes a part of the "Compounding Record" for that prescription. Any dosage unit falling outside the limits should not be dispensed. Even though this is not an official USP test method, it does provide good documentation for a part of your quality assurance program and can be performed in-house.

Next week we will briefly discuss the USP tests on Content Uniformity and Weight Variation.


Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief

House Resolution (HR) 1474, the Fair and Speedy Treatment (FAST) of Medicare Prescriptions Drug Claims Act of 2007. This bill will ensure timely payment for pharmacy services. For more information http://www.house.gov/list/press/ar01_berry/PROMPTPAY.html

There is a lot of activity ongoing regarding the proposed legislation by Senators Kennedy, Roberts, and Burr for the U.S. Food and Drug Administration (FDA) to control compounding. To read more about the proposed bill and hill activities go to www.iacprx.org or www.iacprx.org/site/PageServer?pagename=Press_Releases#030707

Want to know more about taurine? Check out the 52 abstracts and citations that have been added to CompoundingToday.com's literature search database this week at www.compoundingtoday.com/Articles/SearchResult.cfm?Batch=113

Want to know if a drug is on short supply or discontinued? Visit the American Society of Health-System Pharmacists up-to-date website at www.ashp.org/s_ashp/sec_drug_shortages.asp?CID=1500&DID=1544

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Obtain the e-mail addresses of your patients.
E-mails are an inexpensive way to send a newsletter to patients/physicians, to send out prescription refill reminders, and to provide prescription information. Encourage your patients to use this mode of communication to request prescription refills. Also, visit with your physicians to determine if they would be willing to use e-mail interactions for requesting refills, etc. It's much faster than using the telephone and you have a hard copy for documentation, as a reminder and to use as a "work order."