Editorial: Quality Assurance in Compounding, Part VIII

United States Pharmacopeia (USP) Chapter <831> Refractive Index

When placing a stick in water, the stick appears to "bend." The explanation is that the light is being refracted, as it travels slower in water than it does in the air. The refractive index of a substance is the ratio of the velocity of light in air to the velocity of light in the substance being tested.

Refractive Index can be used as part of a quality-assurance program for confirming identity of incoming materials and checking final compounded preparations. Generally, it is limited in pharmacy practice to clear liquids. Refractometry is commonly used to test for specific gravity of urine in clinical/hospital laboratories. There is a relationship between the refractive index of a substance and its specific gravity. Refractometers can have calibrated scales to make them easy to use.

There are many types of refractometers; the most common type used in pharmacy is the Abbe'. It simply takes a "drop" of liquid placed between the two prisms, adjustments made to an easy-to-read endpoint, and the refractive index read.

Refractive index is good for purity determinations for pure substances and confirming the Certificate of Analysis of incoming clear liquids. In compounding preparations that are clear liquids, the refractive index can be determined on a few batches, the tolerance established, and the documentation made part of the testing in the Master Formula and recorded in the Compounding Record each time the preparation is compounded. It only takes about one minute to do this test.


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

SOUTH CAROLINA BOARD RESPONDS!
The South Carolina Board of Pharmacy quickly responded to the editorial published two weeks ago (about purchasing lidocaine via Internet) and has addressed the issue immediately. The South Carolina Board of Pharmacy report they have already closed up three such sites when they became aware of their existence. Kudos to the South Carolina Board! Read below:

Dr. Allen,

The South Carolina Board of Pharmacy had no report of bulk chemicals being provided through the Orangeburg location. We will address that issue immediately. In the future, if you become aware of any Internet distributor of pharmaceuticals in South Carolina, please notify me. We have closed three when we were aware of their existence. Thanks.

Davis Hook, Jr.
SC BOP Member

This Regulatory Update has been provided by the American Pharmacists Association.

FDA to Hold a Public Hearing on Use of Medication Guides
On June 12 through 13, 2007, the FDA's Center for Drug Evaluation and Research (CDER) will hold a public meeting to obtain feedback on the Medication Guide program. APhA is concerned with the growing number of Medication Guides and the logistics for handling them in the pharmacy and would appreciate your feedback as we develop our comments to the FDA. Provide your feedback to APhA at http://r.listpilot.net/c/aphanet/1c8vcw0/deee

An Update on the Safe Compounding Act of 2007 by The International Journal of Pharmaceutical Compounding, Inc.
The Prescription Drug User Fee Act was passed by the Senate without the compounding provisions. This does not mean that the Safe Compounding Act cannot:

1. Be added to PDUFA later

2. Be voted on as a separate bill

     or

3. Incorporated into another bill

As long as Congress is in session, it is vitally important that we all continue to work to ensure our patients and physicians have access to quality compounded individualized medications. Plan on attending Compounders on Capitol Hill on July 7 through 10 in Washington, DC. You'll be glad you did!

Home Health Quality Improvement Campaign 2007
Learn about the Home Health Quality Improvement National Campaign 2007 at www.homehealthquality.org/hh/

Hospice Care Does Not Hasten Death, Study Shows
Researchers hope a new study will help dispel the myth that medications used in a hospice to relieve pain and other symptoms hasten death. On the contrary, they've found that hospice care may actually prolong life. See http://tinyurl.com/365wv7

This week 33 citations and abstracts on the topics of burning mouth syndrome and orofacial neuropathic pain syndromes have been added to CompoundingToday.com's literature search database. See the complete list of new items at www.CompoundingToday.com/Articles/SearchResult.cfm?Batch=119 .

Better Capsules (Continued)
When using the powder tamper, it is important to scrape all of the powder sitting above the capsules away from the capsule openings prior to tamping. If some powder is piled onto the openings and the tamper is applied, more powder will be forced into those holes and less into others. Also, the tamper will only go down as far as the capsules containing the most powder, so some capsules will not be packed as tightly as others. If all excess powder is moved over to one half of the plate, then using the 25 pin tamper, one can tamp those 50 capsules; then, slide the powder over those holes that were just tamped and tamp the remaining 50 capsules. Then, distribute the powder evenly using a perpendicular scraper technique and repeat as often as necessary to get all the powder in the capsules.