a) foreign-made versions of FDA-approved drugs
b) Лекарства, разрешенные к импорту в США от онлайн-продавцов.
То есть по вашему "Any medication" в этом документе относится исключительно к Injectable Cancer Medications ?
Кто-нибудь еще так считает ?
Здесь повторяется точно та же формулировка и не упоминаются Injectable.
Page Last Updated: 06/30/2010
Information on Importation of Drugs Prepared by the Division of Import Operations and Policy, FDA
Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not been manufactured in accordance with and pursuant to an FDA approval.
Последний раз редактировалось Spok7; 29.01.2012 в 13:50.
Спасибо за перенос темы.
Если есть какой-то подзаконный акт, де-факто что-то разрешающий, это не значит, что закона не существует.
Это значит - эти действия противозаконны, но по факту за них не наказывают.
То есть ровно то, о чем я пишу - покупать лекарства онлайн в Канаде противозаконно. Но преследовать за это не будут.
ЕЩЕ РАЗ - точно такой же текст Regulatory (Chapter 9 и т.д.) действовал в 2004 году.
Пруф линк, страница 3 - http://www.ovamed.org/english/histor...S_Citizens.pdf
Поэтому я привожу письмо FDA от 2004 года. В нем ясно указано - онлайн продажа и импорт в США из-за границы лекарств даже FDA-approved - нелегальны.
Повторю свой вопрос -
Профессионалы в медицине, что это значит - The drug must also be dispensed by a pharmacist pursuant to a valid prescription. 21 U.S.C. 353(b)(1) ?
То есть лекарство если и может быть разрешено к импорту частным лицом из-за границы, то только если оно не в оригинальной фабричной упаковке, но в баночке с наклейкой, где указано имя пациента, врача, продавца ? Или я неправильно понимаю ?
Последний раз редактировалось Spok7; 29.01.2012 в 13:56.
В США право прецедентное. Прецеденты обходят/нарушают/противоречат изначальному акту, да еще и с подачи регулирующей и контролирующей организации, что отражено в последних руководствах. Нарушители не преследуются - де факто изначальный акт не имеет силы.
А я - Regulatory Procedures Manual той же самой FDA 2011 года. Письмо от ФДА не послужило причиной внесения изменений в регуляции.я привожу письмо FDA от 2004 года
Мы можем не соглашаться еще денька 3-4, но мне надоело. И в глазах рябит от радуги.
Последний раз редактировалось Юлик; 29.01.2012 в 14:21.
"Мы все плод больной фантазии... Лечить нас надо:-). Пошла помою туалет:-)" (c)uienifer
Да не в последних руководствах от 2011 года, то же самое (инструкция как закрывать глаза на нелегальный импорт) было в этих же руководствах с НАЧАЛА ВЕКА, Двадцать первого века
Это никак не означает, что закон отменили.
Прецеденты имеет право формулировать только Суд.
Были судебные решения об отмене Акта, о разрешении импорта онлайн из Канада в обход закона ? Я таких не нашел.
Последний раз редактировалось Spok7; 29.01.2012 в 14:29.
http://www.fda.gov/NewsEvents/Newsro.../ucm108534.htmUnder the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation--bringing drugs from a foreign country into the United States.
Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices. As part of the FDA's high standards, drugs can be manufactured only at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug's ingredient on a new drug application, the FDA generally travels to that site to inspect it.
After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices. "With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements," McCallion says.
Along with legal requirements on manufacturing, U.S. pharmacists and wholesalers must be licensed or authorized in the states where they operate, and limits on how drugs can be distributed lessen the likelihood that counterfeit or poor-quality drugs will turn up. It's because of such safeguards that the process of getting drugs onto U.S. pharmacy shelves is commonly referred to as a "closed" distribution system.
The FD&C Act also states that prescription drugs made in the United States and exported to a foreign country can only be re-imported by the drug's original manufacturer. Even when original manufacturers re-import drugs, the drugs must be real, properly handled, and relabeled for sale in the United States if necessary.
Although importing unapproved prescription drugs is illegal, the FDA's guidance on importing prescription drugs for personal use recognizes that there may be circumstances in which the FDA can exercise discretion to not take action against the illegal importation.
That means if you buy your high blood pressure or other medication from a foreign country because it's cheaper--even though a drug with the same name is approved for sale in the United States--generally the drug will be considered unapproved and the FDA's personal use guidance will not apply. The Drug Enforcement Administration has additional requirements for controlled drugs.
The Same Goes for Canada
But even if you obtain drugs from a place or in a manner that you consider to be safe, according to the FDA, you are almost always obtaining unapproved drugs. "The law applies evenly to all countries outside of FDA's jurisdiction," says Thomas McGinnis, Pharm.D., director of pharmacy affairs in the FDA's Office of Policy and Planning.
So what about the belief often mentioned in the media that drugs sold in Canada are exactly the same as drugs sold in the United States--made in the exact same manufacturing plants? Some may be, and some may not. For example, drugs sold and distributed in Canada by Eli Lilly Canada come from the company's manufacturing facilities throughout the world--the United States, Europe, Asia, and South America.
Manufacturing facilities that make drugs for Canadians have been approved and registered by Health Canada's Health Products and Food Branch, the federal agency responsible for regulating drugs sold in Canada. This agency is responsible for approving the product labeling, which must be made available in Canada's two official languages, English and French.
But the FDA does not have authority to approve drugs sold in Canada. And if a Canadian company is selling drugs only for export to the United States, and not to Canadian citizens, Health Canada may not regulate the drugs or the company at all. Drugs coming to the United States from Canada may be coming from some other country and simply passing through Canada. The drugs could also be counterfeit, contaminated, or subpotent, among other things (see "Potential Health Risks With Imported Drugs").
When it comes to buying prescription drugs online, Canada is dealing with some of the same regulatory challenges that occur in the United States.
The NAPRA has signed an agreement with the National Association of Boards of Pharmacy (NABP) in the United States and has developed a program in Canada modeled after the NABP's Verified Internet Pharmacy Practice Sites (VIPPS), a voluntary certification program.
A VIPPS seal of approval indicates that an online pharmacy complies with state licensing and inspection requirements, along with other VIPPS criteria dealing with such areas as patient rights to privacy and authentication of orders.
How the FDA Works With U.S. Customs and Border Protection
The FDA's enforcement efforts focus on drugs for commercial use, fraudulent drugs, and products that pose an unreasonable health risk.
If a bag or package arouses suspicion, customs will set it aside and contact the nearest office of the FDA or the Drug Enforcement Agency for advice on whether to release or detain the drug product.
Even though your bag may not be checked, it is against the law not to properly declare imported medications to customs. Failure to declare products could result in penalties.
Possession of certain medications without a prescription from a licensed physician may violate federal, state, and local laws.
Prescription drugs should be stored in their original containers, and you should have a copy of your doctor's prescription or letter of instruction.
If a drug is detained, the FDA is required by law to send you a written notice asking whether you can show that the product meets legal requirements. If you can't, the drug could be destroyed or returned to the sender.
For more information about the CBP, visit the agency's Web site, www.cbp.gov
http://www.fda.gov/Drugs/ResourcesFo.../ucm202675.htmFDA Operation Reveals Many Drugs Promoted as "Canadian" Products Really Originate From Other Countries
An FDA operation found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with "Canadian" pharmacies. Of the drugs being promoted as "Canadian," based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit.
Is it illegal for a foreign pharmacy to ship prescription medicines into the U.S.?
It is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by FDA into the U.S. even though the drug may be legal to sell in that pharmacy's country. Under the scheme that Congress established to ensure that drugs are safe and effective, drugs are tested and test results are thoroughly reviewed by FDA scientists. U.S. law also requires that products approved for sale in the United States have their formulation approved by FDA, be made in a plant registered with FDA, and be produced under quality standards enforced by FDA.
Prescription drugs available from a foreign pharmacy that are products that FDA has not approved; products with similar, but not identical formulations as FDA-approved products; products not made under the quality standards required by U.S. law or labeled according to U.S. requirements; or products not stored or distributed under the quality conditions required in the U.S. cannot be legally sold in the U.S.
Can an American patient get a medication not approved in the U.S. from a foreign dispenser?
As a general matter, it is illegal to import an unapproved drug into the U.S. However, under FDA's personal importation policy, FDA has authorized its inspectors to use their enforcement discretion to allow U.S. residents to import certain products under certain limited conditions. Under this policy, FDA may allow a U.S. resident to bring into this country an unapproved drug for their personal use for a serious condition, if there has been no commercialization or promotion of the drug to U.S. residents.
I was born in a cross-fire hurricane. (c)
А почему в опросе нет варианта "незаконно, наказуемо"?
http://www.pharmacychecker.com/aboutop.asp#C3Legality and risks of purchasing drugs online depend on the specific kind and amount of drug being purchased.
It is illegal to purchase controlled substances from an overseas pharmacy. A person purchasing a controlled substance from such a pharmacy may be violating two federal laws that carry stiff penalties. The act of importation of the drug from overseas violates 21 USC, Section 952 (up to 5 years in prison and $250,000 fine for importation of non-narcotic Schedule III, IV, or V drugs; possibly more for narcotics and Schedule I and II drugs). The act of simple possession of a controlled substance without a valid prescription violates 21 USC, Section 844 (up to 1 year in prison and $1,000 fine). FDA does not recognize online prescriptions; for a prescription to be valid there must be a face-to-face relationship between the patient and the health-care professional prescribing the drug. What exactly constitutes a "face-to-face" relationship is considered by many online pharmacies to be a subjective definition that would allow them to operate as an adjunct to the patient's own physician if the patient submits medical records documenting a condition for which the requested medication is deemed appropriate for treatment. Sections 956 and 1301 provide exemptions for travellers who bring small quantities of controlled substances in or out of the country in person, but not by mail.
CONTROLLED SUBSTANCES AND ONLINE PHARMACIES: USE EXTREME CAUTION
Unlike regular prescription drugs, which are regulated by the U.S. Food and Drug Administration (FDA), most products with a high potential for addiction and abuse are regulated by the U.S. Drug Enforcement Agency (DEA) and called controlled substances. U.S. pharmacies that sell controlled substances must have a license to do so, which is issued by the DEA. [For a list of controlled substances go to http://www.usdoj.gov/dea/pubs/scheduling.html .]
Unfortunately, some U.S. and foreign “rogue pharmacies" sell controlled substances to consumers who don't have a prescription. Americans with a valid prescription may legally order controlled substances from a website that are dispensed from a licensed U.S. pharmacy. Reputable Canadian and other non-U.S. pharmacies will NOT ship controlled substances to Americans. The PharmacyChecker.com Verification Program does not accept online pharmacies that sell controlled substances filled by foreign pharmacies.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) regulates the practice of online pharmacy at the federal level as it relates to controlled substance by making it “unambiguous that it is a per se violation of the [Controlled Substances Act] for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least one in-person medical evaluation.” (Federal Register/Vol. 74 No. 64, April 6th, 2009, p. 15599).
I was born in a cross-fire hurricane. (c)
Конечно, должен быть третий вариант - "незаконно, наказуемо" !
Я не нашел недавних прецедентов, когда частных лиц сажали бы на 5 лет или штрафовали на 250,000, поэтому решил упростить до 2 вариантов ответов.
Последний раз редактировалось Ильич; 30.01.2012 в 07:13.
Скажите, а для чего опрос устроили?
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