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Editorial: What is Compounding Pharmacy, Part IV

This week, we will look at the various definitions of Pharmaceutical Compounding. It is interesting to note that they are not all the same and do not necessarily include all the same activities. Also, individual states may define compounding differently.

H.R. 3204 Definition
"The term 'compounding' includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug."

FDA Note
"� the term 'compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling."

U.S.P. Definition
"The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:

• Preparation of drug dosage forms for both human and animal patients
• Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
• Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients
• Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or academic), teaching, or chemical analysis
• Preparation of drugs and devices for prescriber's office use where permitted by federal and state law."

NABP Definition
"'Compounding' means the preparation of Components into a Drug product (1) as the result of a Practitioner's Prescription Drug Order based on the Practitioner/patient/Pharmacist relationship in the course of professional practice, or (2) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or Dispensing. Compounding includes the preparation of limited amounts of Drugs or Devices in anticipation of receiving Prescription Drug Orders based on routine, regularly observed prescribing patterns."

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

Lunesta Starting Dose Cut in Half
The FDA cut in half the recommended dose of Lunesta, concluding some patients were impaired the morning after taking it even if they felt fully awake. Lunesta, made by the Sunovion Pharmaceuticals unit of Japan's Dainippon Sumitomo Pharma Co., generated U.S. sales in 2013 of $867 million. The drug was introduced in 2005.

About a year ago, the FDA made a similar cut in the recommended dose for zolpidem, sold generically and under brand names including Ambien, made by Sanofi. The FDA says it continues to scrutinize the possible risk of impaired mental alertness with all sleeping aids, including those sold over the counter.

The FDA said data from clinical studies had recently become available that allows the agency to better understand the extent of next-morning impairment.
http://online.wsj.com/news/articles/SB10001424052702304908304579564360145164466?cb=logged0.8154248411866404

FDA, Drug Product Ads and the First Amendment
Legal cases have challenged the FDA's approach to regulating industry communications about medical products, and agency officials are now addressing these developments head-on. Following the U.S. v. Caronia and IMS v. Sorrell, the issue of speech-related activity, including product labeling and advertising and promotion of regulated products, is being addressed.

Encompassed in off-label communications is how they relate to a number of key issues for pharmaceutical marketers, including handling of unsolicited requests, involvement in scientific exchange, providing healthcare economic information, communications with formulary committees, and clinical practice guidelines developed by third parties.
http://blog.pharmexec.com/2014/05/15/fda-takes-first-amendment-issues-seriously/

With Saline in Short Supply, Hospitals Look for Alternatives
The saline solution shortage is forcing hospital pharmacists and healthcare clinicians to stretch existing supplies, find workarounds, and formulate substitutes. It is not just saline solution, but it is all IV solutions in general. The FDA has issued three updates so far this year on the nationwide shortage of saline. Even though drug shortages are not uncommon, hospitals have more experience dealing with insufficient cancer drugs rather than a shortage of bags of saline.
http://healthleadersmedia.com/page-1/QUA-304595/With-Saline-in-Short-Supply-Hospitals-Look-for-Alternatives

Drug Safety Concerns in Wake of Scam
Cumberland Distribution, a Nashville, Tennessee drug wholesaler, has been busted for buying diabetic, blood pressure, and HIV drugs on the streets of Miami and New York and then reselling them to pharmacies nationwide. They sold nearly $60 million in secondhand medications to pharmacies nationwide between 2006 and 2009. This brings up the important question: Just how safe are our drugs? The short answer is they're probably safe; but consumer advocates say there's no way to tell for sure. That has consumer advocates and some lawmakers concerned.

The recently passed Drug Supply Chain Security Act creates a new national electronic "track and trace" system that eventually will require unique product identifiers-such as barcodes-on all pharmaceutical drug packages. The FDA said it will take 10 years to put the new system into place.
http://www.tennessean.com/story/news/2014/05/18/pharmaceutical-safety-questioned-wake-scam/9240121/

Glaxo China Accused of Tax Evasion in Addition to Bribery
GlaxoSmithKline's China unit has been accused by a government-run legal newspaper of failing to pay more than 100 million yuan ($16 million) in import duties and taxes for its HIV treatment. The company evaded the taxes from 2005 to 2008 reports China's Legal Daily newspaper. The Legal Daily is an official newspaper of the China Communist Party's Commission for Political and Legal Affairs. It is "the Party's main mouthpiece in the fields of politics and law," according to its website. GSK also allegedly manipulated prices of other imported and locally made drugs by providing falsified costs to Chinese regulators. Glaxo is investigating allegations its employees bribed doctors in Jordan, Lebanon, Iraq, and Poland; they fired 48 employees last year for violating sales and marketing practices and disciplined another 113.
http://www.bloomberg.com/news/2014-05-19/glaxo-china-accused-of-tax-evasion-by-country-s-legal-newspaper.html

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�that Monday, May 26th, is Memorial Day? Memorial Day, formerly known as Decoration Day, is a federal holiday where the men and women who died while serving in the United States Armed Forces are remembered. The holiday, which is celebrated every year on the final Monday of May, originated after the American Civil War to commemorate the Union and Confederate soldiers who died in the Civil War. By the 20th century, it had been extended to honor all Americans who died while in the military service. As an additional note, it typically marks the start of the summer vacation with Labor Day marking its end.

Take advantage of this day of remembrance to spend with family and remember those who gave their lives to help make America free.

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