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10 votes

Does FDA's "compassionate use" program allow doctors to prescribe drugs to themselves under Emergency Use?

TL;DR: Most likely, for certain drugs. Self-prescribing was never illegal under Federal Law; it is regulated to varying degrees by the states, and discouraged by professional organizations like the ...
Michael's user avatar
  • 2,160
7 votes
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Why does the FDA prevent the sale of health reports that may affect a diagnosis or treatment plan to consumers?

Why would the FDA limit actionable material that may enhance treatment? Because the FDA has a bunch of regulations that say if you are going to sell a medical test you first have to prove that it ...
Charles E. Grant's user avatar
6 votes
Accepted

Cream cheese is cheese?

The FDA promulgates regulations regarding what "cream cheese" etc. is, in 21 CFR Part 133 which covers cheese and related products. Cream cheese is described in §133.133, and there are sections on ...
user6726's user avatar
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5 votes
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Safety and effectiveness have not been established for _

It means what it literally says, that safety and effectiveness have not been established in certain contexts. The rationale behind saying this is §201.57 of 21 CFR 201, a regulation that mandates ...
user6726's user avatar
  • 215k
5 votes

Why is it difficult to import 5-HTP (a form of Tryptophan) into some countries?

From the legal perspective, the question is whether the substance is legal in Australia. The legal root of the matter is the Therapeutic Goods Administration. Dosages above 100 mg are on "...
user6726's user avatar
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4 votes
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Is it illegal for a consumer to obtain or use a non-FDA approved medical device?

The FDA approved the device as requiring a prescription (not OTC). FDA regulations govern the manufacture or distribution of devices and drugs, not the consumption. An overview of FDA regulation is ...
user6726's user avatar
  • 215k
4 votes

Do milk crates have registered owners?

Here is the state of California code regarding the question. I am sure a state by state inquiry could reveal other statutes. http://www.leginfo.ca.gov/cgi-bin/displaycode?section=pen&group=00001-...
Chris's user avatar
  • 41
4 votes
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Can POTUS make FDA approve a drug (such as hydroxychloroquine), or make it available over the counter?

No. Congress, in the Federal Food, Drug and Cosmetic Act, gave the the power to regulate drugs to the FDA, not the President. In addition to giving the FDA jurisdiction, Congress also set up ...
Just a guy's user avatar
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3 votes
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Can the need for FDA authorization of a tool to find infectious people be bypassed by labeling?

This is a duck You can label it a chicken if you like but you won’t fool anyone who knows about ducks. The FDA knows about diagnostic devices; calling it something else isn’t going to fool them.
Dale M's user avatar
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2 votes
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Would it be legal for a diabetic person to extract and use insulin from pig pancrea?

Via the Insulin Amendment Act, later repealed, and the Durham-Humphrey Amendment, the federal government gained the power to regulate insulin, and the Keefauver-Harris Amendment imposed regulatory ...
user6726's user avatar
  • 215k
2 votes

Questioning the meat served at a local restaurant

The FDA is a federal agency and is not going to be a first investigator for a local food or health issue. Contact your local city/county health department with your story and ask them how to get the ...
BlueDogRanch's user avatar
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2 votes

Can I sell an unscheduled compound as a recreational drug in the USA?

If you are offering it as a recreational drug, then it requires FDA approval. If you do sell it, though, you face criminal charges for selling a drug not approved by the FDA which is, generally ...
ohwilleke's user avatar
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1 vote
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What determines the legality of whether a non-controlled substance can be included in food?

The FDA maintains a list of substances "generally recognized as safe" and provides that list on their web site at: GRAS To quote their site: Under sections 201(s) and 409 of the Act, and ...
jwh20's user avatar
  • 3,496
1 vote

How to interpret the US law for Emergency Use Authorization

There is an "and" at the end of (4), so the Secretary must conclude that all of (1)-(5) hold in order to issue an authorization. Similarly, to satisfy (2), it must be reasonable to ...
Nate Eldredge's user avatar
1 vote

Is it legal to sell food or supplement products online in unlabeled packaging?

The FDA has an FAQ with citations to legal authority regarding its labeling requirements. Generally speaking, food sold to the general public in packages must be labeled. There are exceptions for some ...
ohwilleke's user avatar
  • 206k
1 vote
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What are my rights and proper actions if the food contains traces of household chemicals?

An in-house made product is not regulated by the FDA. FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, ...
Damila's user avatar
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1 vote
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At what point does a local garden produce exchange run into legal barriers?

This summary from UrbanAgLaw.org (formerly run by the Sustainable Economies Law Center, but no longer updated) gives a summary of the US federal laws: Traditionally, the FDA has been concerned ...
Michael Seifert's user avatar

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