The manufacture and distribution of all drugs manufactured in dispensed in America are to be
controlled by government agencies, from manufacturer to dispensing.

For a manufacture to produce pharmaceuticals they must register with the FDA and receive a labeler
number. And for every pharmaceutical they intend to produce they must list the drug with the FDA
including all information manufacture and a “unique” national drug code NDC. In production all
manufacturers must test and keep samples and apply lot numbers and expiration dates based on the
containers in which they are distributed, so if any problems occur they can be recalled by the
manufacture and the public warned to maintain safety.

Drugs are classified into six DEA schedules; the first containing “dangerous” substances too risky
and with no benefit to mankind to be allowed on the market. Included in these, since 1970, was
marijuana along with cocaine, heroin, LSD and others. Class II drugs are the opioids, used for pain
by citizens who are also addictive causing our current opioid crisis.

All class II through VI drugs, can only be obtained legally if dispensed by registered pharmacists
or physicians; while all class I except marijuana, which are our societal “killer” supposedly are
not manufactured domestically. Making this worse is the fact that many states have passed laws to
make marijuana legal within their state borders for both medical and recreational use. In states
where marijuana is legal under state law, marijuana doesn’t need a physician’s prescription, be
tested or registered by the FDA or dispensed by a pharmaceutical professional; unlike all other
drugs. The perception in 1970 and before was that these drugs are made abroad and imported into the
United States, to circumvent American drug laws. So marijuana growers with no training and no
testing at all provide thousands of different strengths and compounded drug product to the public
with absolutely no ability to recall or alert the public of known danger, while the FDA regulating
cigarettes and cigars as nicotine delivery devices.

The recent crisis that caused increasing numbers of deaths, start with class II drugs made by some
American manufacturers either here or abroad in facilities that are required to be inspected by the
FDA and to test inspect and apply lot numbers and expiration dates; which we now know often doesn’t
happen at all in foreign facilities. While we watch our borders no one watches those who
manufacture and dispense these “killer“drugs and now move to enable them to sell new overdose
injections over-the-counter. It has been shown over and over again that the main problems is there
is no tight control over these dangerous Class II drugs so this year the drug enforcement agency is
trying to reduce the amount of these products that can be produced.

This is just another example of how the various segments of Health and Human Services mainly the
FDA and the Center for Disease Control, best able to control the problem in manufacturing and
distribution of pain drugs, have failed. Now the Justice Department is trying to solve the problem
in the most ridiculous and inefficient manner. What assures citizens in pain will be able
to obtain the pain drugs they need rather than stopping their distribution to the addicted!

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