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AAS, liver damage thread link

Posted 18 December 2007 - 12:27 PM (#1) User is offline   Heavy_Lifter85 

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No time to read this now but looks interesting at first glance:

http://forum.bodybui...d.php?t=4845843
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Posted 18 December 2007 - 01:43 PM (#2) User is offline   abraxas 

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Baboons fed high alcohol diets along with lecithin showed highly reduced cirrhosis and liver damage. It is my favorite hepaprotective supplement I have ever used. I don't remember there being enough studies on humans though, which is unfortunate.

http://www.thorne.co...idylcholine.pdf
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Posted 25 December 2007 - 07:27 PM (#3) User is offline   SteveSliwa 

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 Heavy_Lifter85, on Dec 18 2007, 11:27 AM, said:

No time to read this now but looks interesting at first glance:

http://forum.bodybui...d.php?t=4845843


They are talking about PPC which is an amazing compound.

 abraxas, on Dec 18 2007, 12:43 PM, said:

Baboons fed high alcohol diets along with lecithin showed highly reduced cirrhosis and liver damage. It is my favorite hepaprotective supplement I have ever used. I don't remember there being enough studies on humans though, which is unfortunate.

http://www.thorne.co...idylcholine.pdf


PPC is a drug in several countries for various liver conditions. Many of the studies in the article linked refer to the PPC form of PC.
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Posted 26 December 2007 - 03:32 AM (#4) User is offline   SweetDaddyPatty 

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So can I buy PPC? from where?
QUOTE (Dr. Lats @ Mar 25 2008, 11:43 PM) <{POST_SNAPBACK}>
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Posted 26 December 2007 - 07:53 AM (#5) User is online   Benson 

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 SweetDaddyPatty, on Dec 26 2007, 03:32 AM, said:

So can I buy PPC? from where?


Its broadly available.

http://www.iherb.com/ProductDetails.aspx?c...d=2649&at=0

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Posted 26 December 2007 - 08:16 AM (#6) User is offline   abraxas 

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 SteveSliwa, on Dec 25 2007, 06:27 PM, said:

PPC is a drug in several countries for various liver conditions. Many of the studies in the article linked refer to the PPC form of PC.



What is the difference between PC and PCC? Phosphatidylcholine and polyenylphosphatidylcholine are the same thing.
PC makes up something around 25% of lecithin granular mixtures, if I correctly recall, what would the advantages or disadvantages of the additional phosphatides be?
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Posted 26 December 2007 - 12:06 PM (#7) User is offline   SteveSliwa 

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 Benson, on Dec 26 2007, 06:53 AM, said:



Thats not PPC in your link. I assume you know what PPC is?
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Posted 26 December 2007 - 12:07 PM (#8) User is offline   SteveSliwa 

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 abraxas, on Dec 26 2007, 07:16 AM, said:

What is the difference between PC and PCC? Phosphatidylcholine and polyenylphosphatidylcholine are the same thing.
PC makes up something around 25% of lecithin granular mixtures, if I correctly recall, what would the advantages or disadvantages of the additional phosphatides be?


PPC is a derivative of PC. It's far more effective than PC. Lecithin is crap aside from a source a fats the other phospholipids hinder PC's ability to work.
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Posted 26 December 2007 - 03:09 PM (#9) User is online   Benson 

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 SteveSliwa, on Dec 26 2007, 12:06 PM, said:

Thats not PPC in your link. I assume you know what PPC is?



According to LEF, these are two different terms for the same compound.

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Posted 26 December 2007 - 03:32 PM (#10) User is offline   SteveSliwa 

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 Benson, on Dec 26 2007, 02:09 PM, said:

According to LEF, these are two different terms for the same compound.


Sadly they don't go into enough details. Pure PPC contains Dilinoleoylphosphatidylcholine up to 52% which is considered the active compound. Most PC products on the market are crude lecithin extracts with unknown amounts of DLPC.
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Posted 26 December 2007 - 03:38 PM (#11) User is offline   abraxas 

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http://www.ncbi.nlm.nih.gov/sites/entrez?d...;indexed=google
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Posted 26 December 2007 - 03:40 PM (#12) User is offline   SteveSliwa 

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 abraxas, on Dec 26 2007, 02:38 PM, said:



Exactly.
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Posted 27 December 2007 - 08:02 AM (#13) User is offline   SweetDaddyPatty 

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 Benson, on Dec 26 2007, 08:53 AM, said:





I edited my post right after I made it, with a link to what looked like a good PPC product from a board sponsor, but it got UNedited. :P
QUOTE (Dr. Lats @ Mar 25 2008, 11:43 PM) <{POST_SNAPBACK}>
more full flaccid penis

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Posted 27 December 2007 - 03:01 PM (#14) User is online   Benson 

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Unique Nutrition is considered to be a source which we will not allow links to. Cognitive Nutrition is a sponsor and carries many of the same supplement stuff minus the Rx meds.

However beautiful the strategy, you should occasionally look at the results... - Winston Churchill
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Posted 27 December 2007 - 03:12 PM (#15) User is offline   SteveSliwa 

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Per Justin's rules he does not want any website that legally sell non controlled drugs on his forum.
Cognitive Nutrition which is a different company does not make or sell PPC but it's easy enough to find online.
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Posted 27 December 2007 - 03:31 PM (#16) User is online   Benson 

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 SteveSliwa, on Dec 27 2007, 03:12 PM, said:

Per Justin's new rules he does not want any website that legally sell non controlled drugs on his forum.


To be specific, I think its prescription-controlled, non-scheduled and non-US approved pharmaceuticals that are the problem.

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Posted 27 December 2007 - 03:35 PM (#17) User is offline   SteveSliwa 

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 Benson, on Dec 27 2007, 02:31 PM, said:

To be specific, I think its prescription-controlled, non-scheduled and non-US approved pharmaceuticals that are the problem.


I've never heard the term prescription controlled?
It is a fact you can legally possess a prescription drug in the US provided it is not a DEA controlled drug.
Justin doesnt want any pharmaces mentioned US or non US approved. I don't see how non US approved is any greater problem than US approved.
That does not many any sense.
Who is it a problem for?
It would make most sense that pharmacies that sell controlled drugs in the US there M&M is based would be a "problem" or greater concern for the DEA shutting M&M down.
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Posted 27 December 2007 - 04:22 PM (#18) User is online   Benson 

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 SteveSliwa, on Dec 27 2007, 03:35 PM, said:

I've never heard the term prescription controlled?
It is a fact you can legally possess a prescription drug in the US provided it is not a DEA controlled drug.
Justin doesnt want any pharmaces mentioned US or non US approved. I don't see how non US approved is any greater problem than US approved.
That does not many any sense.
Who is it a problem for?
It would make most sense that pharmacies that sell controlled drugs in the US there M&M is based would be a "problem" or greater concern for the DEA shutting M&M down.


It seems odd that someone in the supplement and pharmaceutical sales business does not know that there are many drugs that require a prescription to be dispensed but are not scheduled. Sometimes called legend drugs, antibiotics, blood pressure meds, cholesterol lowering agents, anti-depressants, etc. are all examples of drugs that cannot be legally dispensed in any US state without a valid prescription and are all non-DEA scheduled.

All states (and the FDA) prohibit the sale or dispensation of prescription pharmaceuticals (IOW, the practice of pharmacy) by other than a licensed pharmacist or authorized assistant and without the presentation of a valid prescription by the purchaser. Most states also make it a criminal act (usually a misdemeanor) to posses prescription pharmaceuticals for which you do not have a prescription or were not provided to you by a licensed practitioner "in the course of his professional practice". If you don't believe me, take a wallk down to your local Walgreens or Rite-Aid and ask to purchase some sildenafil, tetracycline, lipitor, HCTZ or even fluoride tablets without a script and see how far you get. If its not illegal to sell these drugs without a prescription, why won't they sell them to you? Why will no brick-and-mortar or even licensed mail-order pharmacy sell them to you?

And regarding pharmaceuticals that are not FDA approved, the FDA gives this guidance to consumers on its website. The important point being "The United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and 355(a)), which is administered by FDA, prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness...FDA's guidance is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S. Even if all of 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."

What are considered prohibited sources, for posting purposes, are sites that are actively engaged in practices that violate FDA or state pharmacy regulations which would include sites that sell scheduled drugs, drugs that are not approved for use in the US by the FDA and/or sites that sell prescription drugs (as opposed to OTC or nutritional supplements) and do not require a legitimate script from the purchaser or are not licensed to practice pharmacy in the state where they are incorporated if they are a US company.

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Posted 27 December 2007 - 05:13 PM (#19) User is offline   SteveSliwa 

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 Benson, on Dec 27 2007, 03:22 PM, said:

It seems odd that someone in the supplement and pharmaceutical sales business does not know that there are many drugs that require a prescription to be dispensed but are not scheduled. Antibiotics, blood pressure meds, anti-depressants, etc. are all examples of drugs that cannot be legally dispensed in any US state without a valid prescription and are all non-DEA scheduled.


Only if they are dispensed in the US correct but that have nothing to do with ordering from another country which the FDA does not regulate nor does it deal with possession of a non controlled drug.


Quote

All states (and the FDA) prohibit the sale or dispensation of prescription pharmaceuticals (IOW, the practice of pharmacy) by other than a licensed pharmacist or authorized assistant and without the presentation of a valid prescription by the purchaser. Most states also make it a criminal act (usually a misdemeanor) to posses prescription pharmaceuticals for which you do not have a prescription or were not provided to you by a licensed practitioner "in the course of his professional practice". If you don't believe me, take a wallk down to your local Walgreens or Rite-Aid and ask to purchase some sildenafil, tetracycline, HCTZ or even fluoride tablets without a script and see how far you get. If its not illegal to sell these drugs without a prescription, why won't they sell them to you? Why will no brick-and-mortar or even licensed mail-order pharmacy sell them to you?


Again of course it's illegal to sell within the US however possession of non controlled (state or gov) is a different story.

Most doctors give free samples of many types of drugs WITHOUT a prescription and it is completely legal for them to do so. I've pointed this out to you before but it seems you don't understand or are aware of this. I'm not surprised most people are not but my main consultant is a medical doctor I think he knows more than you respectfully in these matters Benson.

Quote

And regarding pharmaceuticals that are not FDA approved, the FDA gives this guidance to consumers on its website. The important point being "The United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and 355(a)), which is administered by FDA, prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness...FDA's guidance is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S. Even if all of 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."


Again yes the FDA regulates interstate sales however they can't regulate outside the US and they allow vistors from other countries to carry their meds in here provided they are not controlled. You seem to suggest if i came here from Japan and had a blood pressure drug not approved here with me without my prescription with it I would be arrested and that would be illegal. That simply is not the case.

Quote

What are considered prohibited sources, for posting purposes, are sites that are actively engaged in practices that violate FDA or state pharmacy regulations which would include sites that sell scheduled drugs, drugs that are not approved for use in the US by the FDA and/or sites that sell prescription drugs (as opposed to OTC or nutritional supplements) and do not require a legitimate script from the purchaser or are not licensed to practice pharmacy in the state where they are incorporated if they are a US company.


You seem focused on companies guessing research labs that sell within the US. Several mail order pharmacies have legally sold to the US for decades and have had no issues. Just look at all the people on the forum who use deprenyl most of the are not getting it from their doctor.
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Posted 27 December 2007 - 06:46 PM (#20) User is offline   SweetDaddyPatty 

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 Benson, on Dec 27 2007, 04:01 PM, said:

Unique Nutrition is no longer a board sponsor and is considered to be an illegal source for posting purposes. Cognitive Nutrition is a sponsor and carries many of the same stuff minus the Rx meds.

sorry, my bad.
QUOTE (Dr. Lats @ Mar 25 2008, 11:43 PM) <{POST_SNAPBACK}>
more full flaccid penis

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Posted 27 December 2007 - 07:11 PM (#21) User is online   Benson 

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 SteveSliwa, on Dec 27 2007, 05:13 PM, said:

Only if they are dispensed in the US correct but that have nothing to do with ordering from another country which the FDA does not regulate nor does it deal with possession of a non controlled drug.


A company doing business in the United States is subject to federal and state laws. Your company for example, doing business in Illinois, is subject to the regulations of the State of Illinois and the regulations of the FDA/DEA/etc. A pharmacy in the UK would not be subject to state laws obviously but items they sent to the US would be subject to US importation regulations and people living in the US would still be subject to US laws even if their drugs came from outside the US.

Quote

Most doctors give free samples of many types of drugs WITHOUT a prescription and it is completely legal for them to do so. I've pointed this out to you before but it seems you don't understand or are aware of this.


I am fully aware of this and state laws regulating dispensation and distribution of prescription drugs make an allowance for drugs provided directly from a licensed practitioner (MD/DO/PA/NP or anyone licensed to write a script for the same drug). If your medical advisor is licensed by the State of Illinois to practice medicine, he can legally dispense medicine directly to his patients without writing a prescription.

Quote

Again yes the FDA regulates interstate sales however they can't regulate outside the US and they allow vistors from other countries to carry their meds in here provided they are not controlled. You seem to suggest if i came here from Japan and had a blood pressure drug not approved here with me without my prescription with it I would be arrested and that would be illegal. That simply is not the case.


I can only go by what the FDA provides as guidance Steve. If you follow the link I provided which is their web site, it makes it clear that importing unapproved drugs for use in the US is illegal. My guess is that foreign visitors coming here for short term stays are not subject to the same regulations as a matter of international law.

Quote

You seem focused on companies guessing research labs that sell within the US. Several mail order pharmacies have legally sold to the US for decades and have had no issues. Just look at all the people on the forum who use deprenyl most of the are not getting it from their doctor.


I don't want to speak for Justin but I don't think we would have source issues with legitimate US pharmacies, mail-order or otherwise, that were licensed by the board of pharmacy in the state of their incorporation and compliant with FDA and DEA regulations regarding drug importation. We do not permit source posting for research chem companies either. And we are fully aware that there are many people who participate here who have purchased prescription drugs without a prescription just like many of our members also purchase AAS, marijuana, cocaine and other controlled substances but our source posting policy prohibits the discussion of where any of these drugs were obtained.

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Posted 27 December 2007 - 07:26 PM (#22) User is offline   SteveSliwa 

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 Benson, on Dec 27 2007, 06:11 PM, said:

A company doing business in the United States is subject to federal and state laws. Your company for example, doing business in Illinois, is subject to the regulations of the State of Illinois and the regulations of the FDA/DEA/etc. A pharmacy in the UK would not be subject to state laws obviously but items they sent to the US would be subject to US importation regulations and people living in the US would still be subject to US laws even if their drugs came from outside the US.


If a company were to resell any prescription drug of course that would be illegal.

Quote

I am fully aware of this and state laws regulating dispensation and distribution of prescription drugs make an allowance for drugs provided directly from a licensed practitioner (MD/DO/PA/NP or anyone licensed to write a script for the same drug). If your medical advisor is licensed by the State of Illinois to practice medicine, he can legally dispense medicine directly to his patients without writing a prescription.


Which means people can legally possess a prescription drug without a prescription as I stated prior as long as it's not controlled. I'm glad you understand that.

Quote

I can only go by what the FDA provides as guidance Steve. If you follow the link I provided which is their web site, it makes it clear that importing unapproved drugs for use in the US is illegal. My guess is that foreign visitors coming here for short term stays are not subject to the same regulations as a matter of international law.


I've reviewed FDA laws and I came to a different conclusion as I've pointed out the FDA makes exceptions.
Your second sentence doesnt make alot of sense you're saying US law is applied differently to those visiting the US?


Quote

I don't want to speak for Justin but I don't think we would have source issues with legitimate US pharmacies, mail-order or otherwise, that were licensed by the board of pharmacy in the state of their incorporation and compliant with FDA and DEA regulations regarding drug importation. We do not permit source posting for research chem companies either. And we are fully aware that there are many people who participate here who have purchased prescription drugs without a prescription just like many of our members also purchase AAS, marijuana, cocaine and other controlled substances but our source posting policy prohibits the discussion of where any of these drugs were obtained.


As any board your main concern is being shut down by the gov DEA mostly if not also the FDA although I don't see much threat of the FDA for a forum. Imminst and several others forums don't seem to share the same concern however this is aside from the discussion at hand. I personally view something illegal/controlled from the DEA as far more of a concern than the FDA. I'm sure most people would share that viewpoint.
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Posted 27 December 2007 - 09:24 PM (#23) User is online   Benson 

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 SteveSliwa, on Dec 27 2007, 07:26 PM, said:

If a company were to resell any prescription drug of course that would be illegal.


Of course it would be.

Quote

Which means people can legally possess a prescription drug without a prescription as I stated prior as long as it's not controlled. I'm glad you understand that.


As long as the drugs were dispensed to them directly from a licensed provider, they are not required to have a prescription. There are also provisions for couriers and salespeople transporting drugs but this is not the same thing as purchasing them without a prescription from XYZPharmacy.com...

Quote

s
Your second sentence doesnt make alot of sense you're saying US law is applied differently to those visiting the US?


According to the FDA, unapproved drugs can be legally brought into the United States if the person bringing them in "...provides evidence that the product is for the continuation of a treatment begun in a foreign country" (e.g. a prescription). So your Japanese hypertensive who comes here with a bottle of nitrendipine that was prescribed for him by his doctor in Osaka is going to be viewed differently by the FDA than you or I ordering the same meds from an overseas pharmacy. Why would it be illegal for the local Walgreens to sell me acetildenafil and be perfectly legit for an internet pharmacy located three blocks away to sell me the same stuff?

Quote

As any board your main concern is being shut down by the gov DEA mostly if not also the FDA although I don't see much threat of the FDA for a forum. Imminst and several others forums don't seem to share the same concern however this is aside from the discussion at hand. I personally view something illegal/controlled from the DEA as far more of a concern than the FDA. I'm sure most people would share that viewpoint.


I think Justin is concerned about running afoul of any alphabet agency but again, I don't want to speak for him on this matter. I would agree with you that generally, the DEA is a scarier bunch than the FDA.

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Posted 27 December 2007 - 09:49 PM (#24) User is offline   SteveSliwa 

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 Benson, on Dec 27 2007, 08:24 PM, said:

Of course it would be.


Quote

As long as the drugs were dispensed to them directly from a licensed provider, they are not required to have a prescription.


Quote

There are also provisions for couriers and salespeople transporting drugs but this is not the same thing as purchasing them without a prescription from XYZPharmacy.com...


How would a cop (which is the only person who can charge you) know the difference? When talking about possession without a prescription I don't expect a cop to see a bottle of prozac in my car and demand to prove I got it from a doctor as a sample years ago. When it comes down to the law there is no difference.

Quote

According to the FDA, unapproved drugs can be legally brought into the United States if the person bringing them in "...provides evidence that the product is for the continuation of a treatment begun in a foreign country" (e.g. a prescription). So your Japanese hypertensive who comes here with a bottle of nitrendipine that was prescribed for him by his doctor in Osaka is going to be viewed differently by the FDA than you or I ordering the same meds from an overseas pharmacy.


When I travel I take my pills with me in a pill box like most people. I really don't think they are going to demand proof of a non controlled drug or arrest you.
Also several drugs are available OTC in other countries that you could not even have any proof a doctor gave it to you. If i came from Japan to chicago for a few days why would I take all my bottles with me if I only need a few days supply? That doesnt make any sense. Plus I'm not sure what if any weight a doctor's prescription from outside the US would have in the US.

Quote

Why would it be illegal for the local Walgreens to sell me acetildenafil and be perfectly legit for an internet pharmacy located three blocks away to sell me the same stuff?


Because you are going outside the US. Where US law does not apply. US does not regulate international mail. People go to mexico all the time grab some drugs and come right back through the border. I did this back in 98 when I was in El Paso

Quote

I think Justin is concerned about running afoul of any alphabet agency but again, I don't want to speak for him on this matter. I would agree with you that generally, the DEA is a scarier bunch than the FDA.


LOL ok i'll give you points for that statement. But I think the percepted risk from non controlled drugs is minimal.
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Posted 28 December 2007 - 09:08 AM (#25) User is online   Benson 

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Steve you will get no argument from me that prescription control laws are confusing and largely nonsensical...I can buy a bottle of fluoride rinse OTC but need a script to buy fluoride tablets, DXM a powerful disassociative drug with dubious cough-suppressant ability, is available without hassle while marijuana, milder by all accounts and with actual medical uses, is a Schedule I drug and I need to jump through all sorts of hoops to purchase an effective decongestant. The fact that I need a note from my doctor in order to manage my own hypertension, depression, pain or toenail fungus seems absurd to me. And there are lots of murky areas....if I go to Canada to visit my cousin, throw out my back while there and go down to the local pharmacy and purchase some Robaxacet OTC and then carry this back into the US what's my exposure?

Whatever my personal exposure is, it does not change the fact that a US corporation that is dispensing or distributing prescription-controlled drugs (as defined by the FDA) in the United States without a license from a state board of pharmacy to do so is in violation of both state and federal law. It doesn't matter one bit if the drugs are being shipped from India or France if the company taking the money and arranging for the drugs to be delivered (distributing, under the law) and the recipient are both in the US and it gets especially sticky if everyone involved is in the same state. The Walgreens and XYZPharmacy.com both doing business in Chicago are both subject to the same Illinois laws in addition to Federal regulations. This is the issue from a source posting policy.

And while it is still illegal in most if not all states to purchase or possess prescription pharmaceuticals for which you do not have a prescription if they were not dispensed from a licensed provider, you are correct that the chances of being caught or charged (by a DA or US Attorney) is probably remote at best if you are dealing with non-scheduled pharmaceuticals. But again, the fact that the risk of being caught is low does not change the legality of the action.

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Posted 28 December 2007 - 10:16 AM (#26) User is offline   SteveSliwa 

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 Benson, on Dec 28 2007, 08:08 AM, said:

Steve you will get no argument from me that prescription control laws are confusing and largely nonsensical...I can buy a bottle of fluoride rinse OTC but need a script to buy fluoride tablets, DXM a powerful disassociative drug is available without hassle while marijuana, which is by most accounts pretty mild overall, is a Schedule I drug and I need to jump through all sorts of hoops to purchase an effective decongestant. The fact that I need a note from my doctor in order to manage my own hypertension, depression, pain or toenail fungus seems absurd to me. And there are lots of murky areas....if I go to Canada to visit my cousin, throw out my back while there and go down to the local pharmacy and purchase some Robaxacet OTC and then carry this back into the US what's my exposure?


Based on my review of the laws, our MD review, and my own experiences NONE.

Quote

Whatever my personal exposure is, it does not change the fact that a US corporation that is dispensing or distributing prescription-controlled drugs (as defined by the FDA) in the United States without a license from a state board of pharmacy to do so is in violation of both state and federal law. It doesn't matter one bit if the drugs are being shipped from India or France if the company taking the money and arranging for the drugs to be delivered (distributing, under the law) and the recipient are both in the US and it gets especially sticky if everyone involved is in the same state. The Walgreens and XYZPharmacy.com both doing business in Chicago are both subject to the same Illinois laws in addition to Federal regulations. This is the issue from a source posting policy.


You may be getting stuck on the wording of the laws. As the US companies who forward orders to European Pharmacies to the US are not subject to State or Federal laws. Perhaps your under the impression that the several US companies who have been selling european pharmaceuticals since the mid 90's actually charge people directly. There are currently 3 main US companies that I am aware of and when they receive an order they forward all the info to the pharmacy in which the pharmacy takes over at that point. If you read the agreement and terms of contract these pharmacies use to create an affiliate program perhaps you would better understand the legalities involved.

Quote

And while it is still illegal in most if not all states to purchase or possess prescription pharmaceuticals for which you do not have a prescription if they were not dispensed from a licensed provider, you are correct that the chances of being caught or charged (by a DA or US Attorney) is probably remote at best if you are dealing with non-scheduled pharmaceuticals. But again, the fact that the risk of being caught is low does not change the legality of the action.


You seem to be mixing of idea of dealing and possessing a non controlled prescription. No one is talking about dealing or selling within the US as of course that is illegal. As I've stated and proven by several examples it is legal to possess an non controlled drug US approved or not in the US.

While I welcome your input you simply don't have the experience or knowledge I have in these matters.

Unless you have done all of the following:

1. Talked to a lawyer regarding this which I have.
2. Discussed with an MD and received his knowledge in these matters.
3. Actually ordered and/or came from another country with a drug and discussed the matter with a customs agent.
4. Discussed it with other companies who have been doing this for well over a decade.
5. Received a free sample of a prescription drug from a MD and had him explain the legalities of why a prescription is not needed. (Similar to 2).


If you have first hand experience please feel free to share it.

I don't blame you for being confused the FDA's website is not that user friendly. There is however a massive difference trying to understanding the laws from just their website posting various confusing information and dealing with it firsthand. I'm sure you can concede to that.
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Posted 28 December 2007 - 12:05 PM (#27) User is online   Benson 

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I guess we are just going to have to disagree on this one Steve. Justin can read all of this and come to some decision about what he considers a source for purposes of M&M posting policy.

While I am not a lawyer, based on my consultations with licensed pharmacists and lawyers about this, it seems pretty clear to me that an Illinois company taking an order and payment from someone in, say the state of Illinois for simplicity, and then arranging for the delivery of prescription-controlled medications from another source to that person meets the Illinois Pharmacy Practice Act definitions for dispensing and/or distributing, something that requires a pharmacy/pharmacist license.

It also appears that the practice of selling prescription meds via an affiliate program without a prescription from an actual doctor-patient relationship is a violation of federal law as well if these indictments mean anything...and while I agree that the FDA's website contains some contradictory guidance, this statement by William Hubband, Assoc. FDA Commissioner for Policy and Planning given to a US House Committee in March of 2004 makes the government position on the matter pretty clear. [emphasis added]

"The unique qualities of the Internet, including its broad reach, relative anonymity, and ease of creating new or removing old websites, pose new challenges for the enforcement of the Federal Food, Drug, and Cosmetic (FD&C) Act and state laws regulating the practice of medicine and the practice of pharmacy. FDA has found that many Internet sites are actually comprised of multiple related sites and links, thereby making investigations much more complex and resource intensive. The global nature of the Internet creates special problems for effective law enforcement. Different approaches to drug approval and marketing in foreign countries further complicate law enforcement issues for U.S. officials. FDA and other U.S. government agencies must try to work with foreign governments to share information and to develop mechanisms for cooperative law enforcement, but this is a difficult task.

FDA Authority

The types of unlawful conduct that can occur when drugs are sold over the Internet are similar to unlawful activities that occur in other contexts. Under the FD&C Act, FDA has the legal authority to take action against:

* The sale, distribution or importation of an adulterated or misbranded drug;
* The sale, distribution or importation of an unapproved new drug;
* Illegal promotion of a drug;
* The sale or dispensing of a prescription drug without a valid prescription; and
* Counterfeit drugs.

When the Internet is used for an illegal sale, FDA, working with the Department of Justice (DoJ), must establish the grounds for a case, develop the same charges, and take the same actions as it would if another sales medium, such as a storefront or a magazine, had been used. FDA has investigated and referred numerous cases for criminal prosecution and initiated civil enforcement actions against online sellers of drugs and other FDA-regulated products, particularly sellers of drugs not approved by the Agency."

Of course I don't think any of these cases has gone to trial yet so if we are lucky, a sensible judge will throw the whole thing out and allow US citizens the same unfettered access to prescription meds enjoyed by many other civilized people... :)

However beautiful the strategy, you should occasionally look at the results... - Winston Churchill
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Posted 28 December 2007 - 12:30 PM (#28) User is offline   SteveSliwa 

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 Benson, on Dec 28 2007, 11:05 AM, said:

I guess we are just going to have to disagree on this one Steve. Justin can read all of this and come to some decision about what he considers a source for purposes of M&M posting policy.


It's Justin's board he can do whatever he likes with it. I've been one of the main people reforcing his policy. I know several boards (imminst, brainmeta, etc) allow such posts but it's the board owners choice.

Quote

While I am not a lawyer, based on my consultations with licensed pharmacists and lawyers about this, it seems pretty clear to me that an Illinois company taking an order and payment from someone in, say the state of Illinois for simplicity, and then arranging for the delivery of prescription-controlled medications from another source to that person meets the Illinois Pharmacy Practice Act definitions for dispensing and/or distributing, something that requires a pharmacy/pharmacist license.


I don't dispense nor distribute drugs so it does not effect me. Forwarding a list of people who may be interested in certain items to a non US pharmacy is outside US law. How many lawyers did you talk to about this? Did you pay them to look into it or just called them up and asked what someone unfamilar with the law in these matters?

Quote

It also appears that the practice of selling prescription meds via an affiliate program without a prescription from an actual doctor-patient relationship is a violation of federal law as well if these indictments mean anything...and while I agree that the FDA's website contains some contradictory guidance, this statement by William Hubband, Assoc. FDA Commissioner for Policy and Planning given to a US House Committee in March of 2004 makes the government position on the matter pretty clear. [emphasis added]

"The unique qualities of the Internet, including its broad reach, relative anonymity, and ease of creating new or removing old websites, pose new challenges for the enforcement of the Federal Food, Drug, and Cosmetic (FD&C) Act and state laws regulating the practice of medicine and the practice of pharmacy. FDA has found that many Internet sites are actually comprised of multiple related sites and links, thereby making investigations much more complex and resource intensive. The global nature of the Internet creates special problems for effective law enforcement. Different approaches to drug approval and marketing in foreign countries further complicate law enforcement issues for U.S. officials. FDA and other U.S. government agencies must try to work with foreign governments to share information and to develop mechanisms for cooperative law enforcement, but this is a difficult task.

FDA Authority

The types of unlawful conduct that can occur when drugs are sold over the Internet are similar to unlawful activities that occur in other contexts. Under the FD&C Act, FDA has the legal authority to take action against:

* The sale, distribution or importation of an adulterated or misbranded drug;
* The sale, distribution or importation of an unapproved new drug;
* Illegal promotion of a drug;
* The sale or dispensing of a prescription drug without a valid prescription; and
* Counterfeit drugs.

When the Internet is used for an illegal sale, FDA, working with the Department of Justice (DoJ), must establish the grounds for a case, develop the same charges, and take the same actions as it would if another sales medium, such as a storefront or a magazine, had been used. FDA has investigated and referred numerous cases for criminal prosecution and initiated civil enforcement actions against online sellers of drugs and other FDA-regulated products, particularly sellers of drugs not approved by the Agency."


I see where you're confused as these drugs were sold within the US and has nothing to do with non US orders. It's illegal to sell drugs within the US without a prescription from seeing a doctor. It's not illegal to receive a non controlled drug in the mail from outside the US. Just as it's not illegal to bring non controlled drugs into the US.

Quote

Of course I don't think any of these cases has gone to trial yet so if we are lucky, a sensible judge will throw the whole thing out and allow US citizens the same unfettered access to prescription meds enjoyed by many other civilized people... :)


When LEF used to take orders for European drugs through their mag the gov tried to step in and failed.
Currently LEF promotes US and non US approved drugs on their website (http://www.lef.org/offshoredrugs.htm), their book, and by phone they tell you exactly where to go buy them.


Thats not to say this isnt a tad in the grey area however many bodybuilding supplements can also be considered unapproved drugs and grey to sell, dispense and/or distribute within the US.
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Posted 28 December 2007 - 12:46 PM (#29) User is online   Benson 

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 SteveSliwa, on Dec 28 2007, 12:30 PM, said:

.
I don't dispense nor distribute drugs so it does not effect me. Forwarding a list of people who may be interested in certain items to a non US pharmacy is outside US law.


I claim no real expertise here Steve, I'm just speculating and may easily be wrong. And I did not mean to imply that I know you to be engaged in some sort of illegal activity, it just appears that way to me...again, a complete layman...

Although, based on what I have read and been told by people who do have expertise in this area, you may want to ask your lawyer to look up the definitions of "dispense" and "distribute" when it comes to pharmacy practice or put a quick call into the Illinois Department of Professional Regulation and ask them if what you are doing constitutes practice of pharmacy according to them...

However beautiful the strategy, you should occasionally look at the results... - Winston Churchill
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Posted 28 December 2007 - 12:46 PM (#30) User is offline   Tkarrde 

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1st point of clarification:

This is Caleb's board. :)

Second, Benson has outlined excellently M&M's policies. Thank you Benson for doing so in such an eloquent and thoughtful manner.

I'm all about my cake, I'm tryin' to marry betty crocker
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