Editorial: Approved, Unapproved, Legal, and Illegal Drugs

Terminology is oftentimes confusing. What is the difference between an "FDA-approved drug," an "Unapproved drug," and an FDA "Unapprovable drug"? Which ones are legal in the U.S.? Can I compound FDA-approved, FDA-unapproved, and FDA-unapprovable drugs?

An FDA-approved drug is one in which the manufacturer or sponsor has received an approval letter; an official communication from the FDA to an NDA sponsor that allows the commercial marketing of the product.

An unapproved drug is one that has not undergone the extensive FDA review process with subsequent approval. There are still a number of unapproved drugs that are legally manufactured and marketed in the U.S. These are the Pre-1938 drugs and have been addressed in this column previously. This category also includes all compounded preparations or modified commercial products.

A company sponsor of a drug product that has undergone the FDA review process and fails for some reason is issued an "Unapproval drug" letter. This may be subsequently changed with an additional application/information, etc.

The public sometimes gets the idea or impression that unapproved drugs are "illegal" and that only "FDA-approved drugs" are legal to use in the U.S. FDA approval is required for drugs that are going to be manufactured and marketed by a manufacturing facility in the U.S. Compounded preparations are prepared pursuant to a prescription (legally authorized prescription by the state) issued by a prescriber (legally authorized to prescribe by the state) for a patient and compounded by a pharmacist (legally authorized by the state to practice pharmacy).

FDA-approved drugs are obviously legal (and can even be compounded under certain conditions but not if patented). It should be noted that the FDA does not approve an active pharmaceutical ingredient (API) by itself; the FDA approves a final drug product ready for administration. The NDA requires extensive work on the specific formulation for stability, etc. and detailed labeling specific for the commercial product.

Unapprovable drugs by the FDA can be compounded unless patented. As an example, if an NDA is rejected by the FDA for marketing by a manufacturer, that API may still be suitable for compounding for specific patients. One cannot, however, compound drugs that are on the "Drugs Not to Be Compounded" list.

All of the above, done appropriately and within the laws and regulations of the state boards of pharmacy, is legal. It may be done in hospitals, clinics, independent and chain pharmacies, specialty compounding pharmacies, etc. As we all know, all compounded preparations are unapproved drugs; this includes intravenous admixtures, cancer cocktails, pediatric formulations, flavoring of preparations, nuclear pharmaceuticals, and all the nonsterile and sterile compounding that occurs daily. These preparations are all legal, and this activity is governed by the state boards of pharmacy. Again, compounded prescriptions are prepared as the result of a prescription from a prescriber and are for a specific patient, and not for "manufacturing and marketing" to the public.


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

Additional trouble in Greece

1. Norgine to withdraw Klean-Prep; Bausch & Lomb considers steroid eye drops as the situation in Greece is worsening as companies continue to respond unfavorably to the on average 25% price cuts to medicines.
   http://www.scripnews.com/home/More-trouble-in-Greece-Norgine-
   to-withdraw-Klean-Prep-Bausch-and-Lomb-considers-steroid-eye-drops-296743

2. Novo Nordisk and Leo Pharma, two Danish firms, hit out on product supplies and have reacted strongly to Greece's April 29 market decree - which would see price cuts of 25% on average.
   http://www.scripnews.com/home/Greece-situation-worsens-as-Novo-Nordisk-and-
   Leo-Pharma-hit-out-on-product-supplies-296554

Foreign Drug Trials Difficult to Track by FDA
The FDA is only reviewing a fraction of foreign drug trials as companies increasingly move drug testing overseas to reduce costs. The FDA inspected about one percent of foreign drug testing sites in the fiscal year 2008, according to a report issued by the Inspector General for the Department of Health and Human Services. The FDA is responsible for looking out for the safety of patients enrolled in studies of all drugs destined for the U.S. market.

Western Europe remains the largest venue for foreign testing, accounting for 58 percent of patients enrolled in foreign drug trials. But investigators found that countries in South and Central America had the largest numbers of patients per test site; this suggests that drugmakers are eager to test groups with patients from countries with lower operating costs.
http://www.pharmacistelink.com/drugs-and-treatment/19396.html

FDA Approves Lucentis (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion
Genentech has announced that the U.S. FDA has approved Lucentis (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO). The FDA approved this new indication after a six-month Priority Review. In the Lucentis RVO clinical trials, significantly more people treated with monthly Lucentis showed sustained vision improvement during the six-month study with an effect seen as early as seven days.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=713238&contentType=newsarchive&channelID=26

Fraudulent Tamiflu is Dangerous to Patients Allergic to Penicillin
The FDA has notified consumers and healthcare professionals about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin.

The FDA purchased the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by visiting the OCI website (http://www.fda.gov/OCI).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm216183.htm

�that the International Academy of Compounding Pharmacists' Compounders on Capitol Hill that was held this week in Washington was a great meeting? If you did not attend, please plan now for next year!

Air Conditioning

The heat of summer is here. Oftentimes it pays to have your air conditioners serviced to run at optimum efficiency. The service call may result in savings of hundreds of dollars this summer!