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Editorial: Unapproved Drugs, What's the big deal?

What do the following drugs have in common?

• Acetaminophen, Codeine Phosphate and Caffeine Capsules and Tablets
• Amobarbital Sodium Capsules
• Amyl Nitrate Inhalant
• Chloral Hydrate Capsules, Syrup and Suppositories
• Codeine Phosphate Injection, Oral Solution and Tablets
• Codeine Sulfate Tablets
• Colchicine Injection and Tablets
• Digitoxin Tablets
• Digoxin Elixir and Tablets
• Ephedrine Sulfate Capsules and Injection
• Ergonovine Maleate Injection and Tablets
• Ergotamine Tartrate Tablets
• Hydrocodone Bitartrate Tablets
• Hydrocodone Bitartrate, Aspirin and Caffeine Tablets
• Hydromorphone Hydrochloride Suppositories
• Levothyroxine Sodium for Injection
• Morphine Sulfate Oral Solution and Tablets
• Nitrolycerin SL Tablets
• Opium Tincture
• Oxycodone Tablets
• Oxycodone Hydrochloride Oral Solution
• Paregoric
• Phenazopyridine Hydrochloride Tablets
• Phenobarbital Capsules, Elixir and Tablets
• Phenobarbital Sodium Injection
• Pilocarpine Hydrochloride Ophthalmic Solution
• Potassium Bicarbonate Effervescent Tablets for Oral Solution
• Potassium Chloride Oral Solution
• Potassium Gluconate Elixir and Tablets
• Potassium Iodide Oral Solution
• Quinine Capsules
• Quinine Sulfate Tablets
• Salsalate Capsules
• Sodium Fluoride Oral Solution and Tablets
• Thyroid Tablets

Simple……these are examples of "Pre 1938" products that have never been approved by the FDA. They were all "grandfathered in" and allowed to remain on the market without further regulatory approval if they were labeled with the same conditions of use.

What's the point? When someone discusses "FDA-unapproved drugs", inform them that some of the most important drugs on the market today are unapproved by the FDA, including these pre-1938 drugs, compounded preparations, intravenous admixtures, etc. It is interesting that the media and even others in leadership positions, cast disparaging remarks that compounding is involved with FDA-unapproved drugs and do not even realize the number of FDA-unapproved drugs that are on the commercial market manufactured by the pharmaceutical industry. The fact is, patients depend upon FDA-unapproved drugs every day. As has been mentioned in this column before, ANY manipulation to an FDA-approved drug outside the FDA-approved labeling, changes it to an FDA-unapproved drug.

We all need to be educated so we can appropriately respond to these misrepresentations and untruths that are propagated in the media.

For a more complete list of Pre-1938 drugs, please go to: http://compoundingtoday.com/FDA

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

Need a book related to compounding? Look no further than CompoundingToday.com. All of the books and the reviews published in the International Journal of Pharmaceutical Compounding for the last nine years have been uploaded to CompoundingToday.com. Not only can you read the review and view a picture of the book, but you can click a link to purchase the book through Amazon.com.

CompoundingToday.com book database is just one more electronic tool to save you researching time and money. CompoundingToday.com is the one-stop shop for compounding information and resources.

• Bolour S. Braunstein G. Testosterone therapy in women: A review. Int J Impot Res 2005; 17(5): 399-408.
• Castro-Diaz D, Amoros MA. Pharmacotherapy for stress urinary incontinence. Curr Opin Urol 2005; 15(4): 227-230.
• Dessole S. Rubattu G, Ambrosini G et al. Efficacy of low-dose intravaginal estriol on urogenital aging in postmenopausal women. Menopause 2004; 11(1): 49-56.
• Haefner HK, Collins ME, Davis GD et al. The vulvodynia guideline. J Low Genit Tract Dis 2005; 9(1): 40-51.
• Kessel B, Nachtigall L, Plouffe L et al. Effect of raloxifene on sexual function in postmenopausal women. Climacteric 2003; 6(3): 248-256.
• Agrawal YP. Low dose naltrexone therapy in multiple sclerosis. Med Hypotheses 2005; 64(4): 721-724.
• Eilertsen AL, Hoibraaten E, Os I et al. The effects of oral and transdermal hormone replacement therapy on C-reactive protein levels and other inflammatory markers in women with high risk of thrombosis. Maturitas 2005; 52(2): 111-118.

There are now more than 300 Standard Operating Procedures on CompoundingToday.com. The following are the top most downloaded SOPs:

• Cleaning and Disinfection
• Employment Information
• Room Cleaning Procedures - Compounding Room
• Documentation of Employee Training
• Prescription Order Intake
• Annual Controlled Substances Inventory
• Tacky Mat Maintenance
• Geometric Dilution Pulverization by Intervention with Manual Mortar and Pestle
• Inventory - Veterinary Supplies.doc
• Room Cleaning Procedures - Clean Room

This Regulatory Update has been provided by the International Academy of Compounding Pharmacists. For more information, www.iacprx.org.

Agriculture Appropriations - AmPharmCo
We have good news! IACP has successfully blocked yet another threat to our profession. Since early September, IACP has been monitoring an unfavorable proposal being considered for inclusion in the 2006 Agriculture Appropriations bill. AmPharmCo, a Ft. Worth, Texas-based veterinary healthcare company, had lobbied its Member of Congress to fund a new FDA study that might have allowed FDA to further encroach on compounding pharmacies. Read more >>

FDA/FTC Announce Joint Action Against Firms Marketing Alternative Hormone Therapies
On Thursday, November 10, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) coordinated in taking enforcement action against a number of firms that sell alternative hormone therapies. FDA issued warning letters to 16 firms that made claims about the benefits of dietary supplements and hormone creams. FTC issued letters to 34 websites that promoted the benefits of alternative hormone therapies stating that "FTC is unaware of any competent and reliable scientific evidence to support the claims." The FDA/FTC news release is available at http://www.fda.gov/bbs/topics/news/2005/NEW01260.html. Read more >>

CETA Publishes Guidance on Isolators Used in Compounding
On November 8, the Controlled Environment Testing Association (CETA) published a guide on isolators used by facilities that compound sterile preparations. The guide is an excellent resource for pharmacists that are considering purchase and installation of such a device. Read more>>

CompoundingToday.com has recently added Ebay auction listing pages for collectibles, antiques, and books. There is also a separate listing page for mortars and pestles. Members (even trial members) can have their compounding and pharmacy related Ebay auctions listed in a 'members auction' section to be seen by users focused on the compounding industry.

A featured neat-o item from Ebay is displayed on the front page and you can access the other listings using the 'More Auctions' link just below it.

Need to remove entrapped air from gels?
If you have access to a centrifuge, it can be used to aid in removing entrapped air from gels. An alternative is to warm the gel (unless it is a Pluronic gel) so that it becomes a little thinner and allows the air bubbles to rise to the top. Another method is to apply a vacuum to the container to bring the air to the top so the bubbles can be burst. Many devices can be assembled to accomplish this, including a syringe and a piece of plastic tubing to fit over the syringe tip and the nipple attached to an appropriately sized dispensing or electronic mortar and pestle container.