To place a classified advertisement please contact: Lauren Bernick lbernick@ijpc.com or 405-513-4236

Editorial: More on the United States Pharmacopeia General Notices, Part VI

MONOGRAPH COMPONENTS
This section is rather long and detailed so a part of it will be discussed generally; it contains the following subsections:

5.10. Molecular Formula
The molecular formula, when appropriate, defines the article (substance) named and is intended to designate the chemical entity or entities, as given in the complete chemical name of the article assuming absolute purity.

5.20. Added Substances
Added substances are not to be included in an official article and are prohibited if they generally involve producing an effect, impairment of the bioavailability, therapeutic efficacy, or safety of the official article, or they may interfere with the assays and tests prescribed for compendial compliance. Air in a container of an official article may be evacuated or replaced by carbon dioxide, helium, argon, or nitrogen, or by a mixture of these gases.

5.20.10. Added Substances, Excipients, Ingredients in Official Substances
Only specific added substances permitted by the individual monograph can be included in official substances. When permitted, the label shall indicate the name(s) and amount(s) of any added substance(s).

5.20.20. Added Substances, Excipients, and Ingredients in Official Products
Appropriate excipients can be included in official product formulations to enhance stability, usefulness, or elegance, or to facilitate its preparation (unless otherwise specified in the individual monograph). These excipients may include antimicrobial agents, pharmaceutical bases, carriers, coatings, flavors, preservatives, stabilizers, and vehicles may be added to an official product. Coloring substances may be incorporated into official products but not those intended for parenteral or ophthalmic use if appropriate guidelines are followed.

Ointment and suppository base compositions may be varied to maintain a suitable consistency under different climatic conditions, provided that the concentrations of active ingredients are not varied and provided that the bioavailability, therapeutic efficacy, and safety of the preparation are not impaired.

5.20.20.1. In Compounded Preparations
Official compounded preparation formulas shall contain only the ingredients named in the monograph unless specifically exempted. Deviation from the specified processes or methods of compounding may occur provided that the finished preparation conforms to the relevant standards and to preparations produced by following the specified process.

This section also discusses the use of ingredients where an allowance is made for the water or other volatile substances present in the quantity taken and specially denatured alcohol formulas.

(Editor's Note: Please review Part III of this series regarding compounded preparation names that appeared in the 9/30/2011 issue found at 3.20.)

5.20.20.2. In Dietary Supplements
Ingredients may be added to dietary supplement products if the additional ingredients comply with applicable regulatory requirements and do not interfere with the assays and tests.

5.30. Description and Solubility
A monograph may describe an article but information about an article's "description and solubility" is provided separately in a reference table (Description and Relative Solubility of USP and NF Articles) in a different section of the compendia. The approximate solubility of a compendial substance is described by descriptive terms in this section (freely soluble, very soluble, soluble, etc.).

Most of the other components of the monograph are important for manufacturers, producers, providers, and laboratories for compliance with the contained standards. Pharmacists will use the resulting data in the form of a Certificate of Analysis (CofA). These sections include: 5.40.Identity; 5.50. Assay; 5.50.10. Units of Potency (Biological); 5.60. Impurities and Foreign Substances; 5.60.10. Other Impurities in USP and NF Articles; 5.60.20. Residual Solvents in USP and NF Articles; 5.70. Performance Tests; 5.80. USP Reference Standards.


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

Delaying Generic Competition by Another "Score" on a Tablet!
Adding another so-called score, or line, across a tablet may force generic rivals to rework their own versions, which amounts to a delay in approval and more profits for the drug company. This has just occurred when Warner Chilcott added a score to its Doryx acne product.

Supposedly, the additional score will make it easier for patients to divide a Doryx tablet into thirds. The Doryx tablets had one score, which generic rivals planned to copy and sell by September 30. However, on September 21, Warner Chilcott added a second score to its tablet and filed a citizen's petition asking the FDA to reject any copycat that lacked the new design.

The petition states that approving a generic with one score "would raise public health concerns." The company argued that prescribers might write a prescription for Doryx and instruct patients to divide its 150-mg tablet into thirds, but patients would find it difficult to obtain the correct dose from a table with one score. "This could lead to patient confusion and sub-optimal dosing," according to the petition.

In August, the FDA issued new draft guidance on scoring tablets and the sort of data that companies need to submit on their applications to support scored tablets. This new guidance was issued partly because a growing number of insurers and prescribers are encouraging cash-strapped patients to split their meds.
http://www.pharmalot.com/2011/10/how-to-delay-generics-draw-a-line-on-a-pill/

New Ipratropium-albuterol CFC-free Spray to Treat COPD Approved by FDA
The combination of ipratropium bromide and albuterol sulfate (Combivent Respimat) inhalation spray for treatment of chronic obstructive pulmonary disease (COPD) has been approved by the FDA. This treatment is a non-aerosol form of the existing Combivent Inhalation Aerosol, which is being phased out due to restrictions placed on products that produce chlorofluorocarbons as a result of the Montreal Protocol on Substances that Deplete the Ozone Layer. The new delivery system uses a slow-moving mist rather than a propellant-based delivery in a single inhalation-per-dose.
http://www.medpagetoday.com/Pulmonology/SmokingCOPD/28973

Patients Die Because of Drug Shortages
"How can they write me an IOU for medication?" Aiello, 26, was on his last few courses of Atra, a drug known to raise cure rates to 80 percent from the usual 40 percent. But when he went to the pharmacy at Massachusetts General Hospital to get his medication at the beginning of September, he was told there wasn't any.

Aiello's doctor, Eyal Attar, uses much stronger language. "It's absolutely outrageous that we cannot have these drugs available in our country - with one of the most advanced medical systems available to treat our patients. It is very frustrating and it makes me, quite frankly, angry."

According to a recent survey by the American Hospital Association, 99.5 percent of hospitals have experienced a drug shortage in the past six months and about 82 percent have had to delay treatment; also, more than 50 percent report that they were not able to provide patients with the recommended treatment.

One source said "We're dealing with 286 different shortages." Also, we have a staff of four that's dedicated to sourcing medications on shortage.

As another example, recently on a Monday morning, Emory learned there was no intravenous valium to put on its crash carts; IV vitamins were in short supply as were front-line chemotherapy drugs. The facility also only had a day's supply of the anesthetic propofol at one of its four hospitals.

"It really is gut wrenching," Dr. Attar says, "especially when it gets to questions of treating adults versus kids. Treating patients with up-front disease versus patients that have relapse disease. These are some very difficult decisions that we don't like to make."

Reasons given for the shortages include (1) some pharmaceutical companies have experienced manufacturing delays, (2) raw materials may be in short supply, and (3) since most of these drugs have been off-patent for years, some drug companies don't want to spend the money to upgrade lines to produce drugs with slim profit margins.
http://www.foxnews.com/health/2011/10/13/hospital-drug-shortages-threaten-patient-health-prove-costly/

�Amendment 10 - Powers of the States and People. Ratified 12/15/1791.
The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

Required Reading
In our "politically charged" contemporary environment, go back and read the Constitution and its Amendments!

Compounding Equipment Wanted
Needed: 2 used ointment mills and 1 digital Ohaus scale. Also interested in any other used pharmacy compounding equipment. Contact Juan at (909) 987-2518.