Editorial: Quality Assurance of Oral and Topical Liquids

Editor's Note: This is the second in a series of brief quality-assurance notes and reminders on different compounded dosage forms. Many of the testing methods can be done in-house and some may need to be outsourced; this is up to the individual pharmacist. However, a program of quality assurance is the responsibility of compounding pharmacists in all aspects of their practice.

Oral and topical liquids are commonly compounded today. There are many relatively simple tests that can be done in-house on liquids, including observation and pH. Others can be conducted either in-house with proper equipment or outsourced to an analytical laboratory. The pharmacist can select the appropriate tests, conduct or outsource them, and document the results on the compounding record for the individual compounded preparation.

Quality-control assessment generally used for these oral and topical liquids includes:

1. Weight and/or volume of the final preparation
2. pH
3. Specific gravity
4. Active-drug potency/assay
5. Color and clarity (if applicable)
6. Globule size range (if an emulsion)
7. Particle size range (if a suspension)
8. Rheological properties/pourability
9. Physical observation
10. Physical stability (discoloration, foreign materials, gas formation, mold growth).

Procedures for these tests are described and a worksheet to be used in association with the compounding record is provided in a publication of the International Journal of Pharmaceutical Compounding,¹ as well as on www.CompoundingToday.com.

Reference
1. Allen LV Jr. Standard operating procedure for quality assessment of oral and topical liquids. IJPC 1999; 3(2): 146-147.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

FDA Acts Against Unapproved Drugs: Morphine, Hydromorphone, Oxycodone
On Tuesday, the U.S. Food and Drug Administration (FDA) warned nine companies to stop making and distributing 14 unapproved narcotic products. They include oral morphine solutions and immediate-release tablets containing morphine, hydromorphone, or oxycodone.

Investigators Win Approval of Fake Medical Product
Government Accountability Office (GAO) investigators looking into lax screening of medical research said that they easily won approval from a private review board of a fake product to be used in medical testing on human subjects.

The GAO also said it was able to register with the Health and Human Services Department a fictitious institutional review board (IRB; a panel of doctors and scientists that must approve any medical drug or device to be used in federally funded testing on humans). The president of this fake review board was a dog named Trooper.

While two of the IRB's competitors rejected the fake product as "junk" or the "riskiest thing I've ever seen on this board," the third said it was "probably very safe." The company involved has charged back that the GAO violated federal and state criminal laws by falsely representing itself to be a medical device company and forging a medical license.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1897688&contentType=sentryarticle&channelID=33amed Trooper

Cardinal Health to Cut 1,300 Jobs at Clinical Unit
Cardinal Health Inc. has announced that its clinical and medical products unit will eliminate 1,300 jobs, with most of the cuts made over the next six months, as hospitals cut back on equipment purchases.

Industry Money Jeopardizing Integrity of Medical Associations, Experts Say
Health experts are saying that professional medical societies are at risk of eroding the public's trust in medicine and should nearly eliminate money they receive from drug and medical device manufacturers.

The push to curb industry contributions has emerged as physicians come under increasing scrutiny in Congress over perceptions of conflicts of interest and concerns over professional integrity in medicine.
http://jama.ama-assn.org/cgi/content/short/301/13/1367

IMS, SDI Seek U.S. Supreme Court Review in Critical First Amendment Case
IMS Health reports they have filed a joint petition for a writ of certiorari with the U.S. Supreme Court in the case of IMS Health vs. Ayotte, the U.S. Court of Appeals First Circuit ruling that upheld a New Hampshire law restricting the commercial use of prescriber-identifiable data.

This decision has reversed a U.S. District Court decision that previously ruled that such restrictions were in violation of the First Amendment's protection of commercial speech. The appellate court, instead, found that the First Amendment afforded no such protection to the gathering, analysis, or publication of data for commercial purposes, and that restriction of such data was not an abridgment of free speech. A writ of certiorari asks the Supreme Court to review the lower court's opinion.
http://pharmalive.com/news/index.cfm?articleID=614990&categoryid=9&newsletter=1

�back in the 60s and 70s, the FDA removed from the market the "combination" medications because of "lack of flexibility of dosing." Today, they are looking at combining up to seven different drugs in a single dosage form called the "Polypill"! d�j� vu? If it was so dangerous then, what has changed?

CCH 2009
To get up-to-date seminars on compounding and to meet with your elected representatives and senators in an organized and effective setting, plan to attend the IACP 2009 Annual Meeting & Compounders on Capitol Hill. The event occurs June 13-16 in Washington, DC.