The US Food and Drug Administration's Federal Food, Drug and Cosmetic Act goes to great lengths to define and describe an "adulterated drug". Two full pages, in fact. Reading this 57 page document is a lot like stuffing pimentos into olives while wearing boxing gloves. It's tedious, frustrating and hard to stay focused. It will leave you on the edge of your seat - which is the only place you can remain without actually falling asleep. I'll spare you the laborious details and get to the good parts. You can read it in its entirety if you're into that sort of torture by clicking on the following link. (FD & C Act Chapter V, sec.501).

Sub-chapter A, (2)(B) states:

"A drug or device shall be deemed adulterated - if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess."

They go on to say in Chapter III Prohibited Acts and Penalties, Section 301 "The following acts and the causing thereof are hereby prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded. (b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated..."

In essence, introducing or receiving a drug known to be adulterated into interstate commerce is illegal and punishable by law - fines and imprisonment. So is causing a drug to become adulterated while in interstate commerce, which I find an interesting caveat.

The fines, by the way, are on a "for each occurrence" basis - not a one time deal. The use of the term holding is an interesting one. "Holding" of a drug occurs when the drug is being distributed, transported, warehoused or stored.

"Storage (holding) of a drug at appropriate temperatures and under appropriate conditions is a requirement" within current Good Manufacturing Practices (cGMP). Code of Federal Regulations Title 21, Sub-chapter C, Part 205 Sec. 205.50(c)

This is the basis the FDA has for introducing distribution practices as an extension of GMP. Anyone and everyone involved in the distribution of drug products, therefore, is not only responsible but indictable. I thought you should know...