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Compounding �Unapproved New Drugs�
Do pharmacists compound with �unapproved new drugs�? It sounds like we are doing something illegal everytime the media reports on compounding. What is an �unapproved new drug� and what is a �new drug�?
A �new drug� is defined by the Food and Drug Administration as �any drug that is not recognized as being safe and effective in the conditions recommended for its use among experts who are qualified by scientific training and experience�.
A drug need not be a new chemical entity to be considered �new�. A change in a previously approved drug product�s formulation or method of manufacture constitutes �newness under the law�, since such changes can alter the therapeutic efficacy and/or safety of a product. Further, a combination of two or more old drugs or a change in the usual proportions of drugs in an established combination product is considered �new� if the change introduces a question of safety or efficacy. Also, a proposed new use for an established drug, a new dosage schedule or regimen, a new route of administration, or a new dosage form all cause a drug or drug product�s status to �new� and triggers reconsideration for safety and efficacy.
After reading this, one can see that technically, �yes, pharmacists do compound unapproved new drugs�, according to the FDA. However, it must be remembered that the bulk USP and NF grade pharmaceuticals used in compounding are the identical to those used in manufacturing �approved new drugs�. The difficulty is in the definition of a �new drug�. The active USP ingredients used in compounding are actually components of manufactured �approved new drugs� but, according to the definition by the FDA, the same active ingredients in a different dosage form or in another dosage form that has not specifically gone through the FDA approval process, is a �new drug�; hence an �unapproved new drug�.
Using commercial products in compounding results in �unapproved new drugs�. For example, if a commercial tablet is pulverized and placed in a liquid vehicle for a pediatric patient (since most commercial drug products do not have a pediatric liquid available), that �approved drug� now becomes an �unapproved new drug� because it has been converted into an oral liquid.
Also, intravenous admixtures prepared in hospitals from �approved� drugs become �unapproved new drugs� when the admixture is prepared by the pharmacy for the patient.
When confronted with this question of why we compound unapproved new drugs, it may be appropriate to explain that �pharmacists compound using USP and NF grade chemicals which are identical to those used in FDA approved drugs manufactured by a drug company; but the exact formula or dosage form compounded is different and has not gone through the lengthy and costly FDA approval process. Pharmacy compounding is exempt from that process because we compound medications individually and specifically for you on the prescription from your physician.
So, technically, the �drugs� are the same and of the same quality in both �approved manufactured products� and �unapproved compounded preparations�. However, due to the technical definition of the term �new drug�, we compound �unapproved new drugs�.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief
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