How To Get Special Or Nonstandard Prescription Drugs From US Or International Sources
COMPOUNDING PHARMACIES and IMPORTATION
A. COMPOUNDING PHARMACIES
B. IMPORTING DRUGS FROM OTHER COUNTRIES
C. SAMPLE PRESCRIPTION FOR AMPHOTERICIN-B
Compounding Pharmacies: Amphotericin-B in oral capsules and nystatin in powder form, as described in the Triple Rx Treatment Strategy, will not be available from most local pharmacies. These prescription drugs must be obtained from compounding pharmacies. Compounding pharmacies are licensed in every state, and there are a couple thousand compounding pharmacies nationally, so there is likely to be one near you, wherever you are.
There may be wide variations in pricing, so you may want to check a couple of sources before deciding on a pharmacy. After deciding on a pharmacy you can mail or fax them your prescription or have your doctor of nurse practitioner call or fax them your prescription.
We have three suggestions on finding a compounding pharmacy in your vicinity that can provide either of these prescription drugs. Once you get a name and number, call them and ask if they can provide the medication you are interested in. Try these sources:
- The Open Directory Project, to which Google and other ISP's and search engines belong, includes a category for compounding pharmacies, so reviewing this list might reveal a compounding pharmacy close to you. Click here, or go to http://directory.google.com/top/health/pharmacy/compounding.
- The International Academy of Compounding Pharmacists http://www.iacprx.org/referral_service/index.html lists about 1300 members in the US and Canada. A quick check that we made disclosed that they included many but certainly not all of the compounding pharmacies in our vicinity. Nevertheless, 1300 provides a lot of choices. Click on the provided link to access their web page, then query on your zip code.
- Compounding pharmacies are licensed by each state, and so the state licensing organization will have a registry of every licensed compounding pharmacy. Call, write, or check out the web site for your state government. Most state government web site domain names have the form www.state.XX.us, where XX is the two-letter abbreviation for your state.
You may wish to compare the prices of a local compounding pharmacy with these sources that are known to provide oral amphotericin-B and nystatin powder:
Importing Drugs From Other Countries: The FDA Personal Use Import Policy for Prescription Drugs not Available in the USA accommodates needs for prescription drugs not currently available in the United States. The essence of the policy is that drugs that are not FDA approved are illegal in the US, but the FDA, under some circumstances, conveniently ignores the prohibition of those illegal drugs.
The following policy guidelines are contained in:
US FDA REGULATORY PROCEDURES MANUAL
PART 9 IMPORT PROCEDURES
CHAPTER 9-71 COVERAGE OF PERSONAL IMPORTATIONS
United States customs inspectors refer inspection and decisions about importation of drugs and medicines to a FDA inspector. When medicines are brought into the US from abroad, either by mail or in personal baggage, the following guidelines apply.
FDA inspectors have broad discretion either to allow importation or to seize drugs that are not FDA approved in the USA. There is no way to insure that a particular medication will be allowed in. One inspector might let it pass and another might confiscate the product.
If the following conditions are met, an inspector has discretion to allow importation.
- The drug must not be commercially available or promoted in the US.
- The quantity of the drug must not normally consist of more than a 90-day supply.
- The drug cannot pose an unreasonable risk of harm.
- The intended use of the drug must be appropriately identified and the use must not be for a serious condition. If for treatment of a serious condition, the drug must be documented in writing as continuation of a course of therapy begun abroad, and the shipment must indicate the name and address of a US licensed physician who will be responsible for continuing care.
Specifically, the answer to our query relating to importation of an oral form of amphotericin-B yielded the following response from the FDA:
1) NDA 050-341 is FDA approved.
2) Even though the application is approved, the product would be from a foreign source and therefore unapproved. The personal importation guidance is pertinent to all unapproved drugs, if the conditions apply.
Please note the following with respect to the personal importation guidance:
"The guidance document is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S., and even if all the factors noted in the guidance are present, the drugs remain illegal and FDA may decide that such drugs should be refused entry or seized. Similarly, the factors noted in the guidance, and documentation that should be obtained from individuals importing the drugs, are not mandatory requirements. They are intended to guide FDA enforcement discretion and should not be represented as binding requirements. The statements in the RPM are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person."
Furthermore, the following appears in a FAQ on the FDA web site regarding the importation of CIPRO (an antibiotic):
"The Federal Food, Drug, and Cosmetic Act (FFDCA) does not permit the importation (including importation for personal use) of unapproved foreign versions of drugs which are approved for use in the US. FDA does exercise limited enforcement discretion in the case of individuals wishing to import an unapproved drug for their personal use, but only if the drug in question does not have an approved version available in the US. Since an approved version of Cipro is available in the US, personal importation of any unapproved version is not permitted."
Confused? Well, it’s the government - what can you expect.
Sample Prescription: Your doctor's prescription for amphotericin-B can be written using the sample below. The following sample will provide a 90 day supply of 250 mg capsules. The dosage can be changed to 500 mg, if desired. Amphotericin-B will keep in the freezer for many years, long after the printed expiration date.
DOCTOR'S NAME, ADDRESS, PHONE, AND LICENSE NUMBER
Patient's Name ___________________________ Age________ Birthdate ____________
Address _______________________________________ Date _____________________
Amphotericin-B (oral form) Capsules 250 mg
Directions: one capsule four times daily as directed
Doctor's Signature ______________________________