DEA’s placement of carisoprodol in schedule IV subjects manufacturers, distributors, dispensers such as pharmacies and physicians, importers, exporters, and anyone in possession of the drug to the applicable provisions of the CSA and its implementing regulations, including administrative, civil and criminal sanctions.

DEA’s final rule establishes the following timetable:

a.  Manufacturers, distributors, dispensers, importers, exporters, researchers, and persons conducting instructional and chemical analysis must submit an application for registration to DEA by January 11, 2012.  Entities currently conducting these activities may continue until DEA has approved or denied their application for registration;

b.  Entities electing not to obtain a DEA registration, or who cannot obtain a registration, must surrender all stocks of carisoprodol pursuant to 21 C.F.R. § 1307.21 on or before January 11, 2012.  Entities may, in the alternative, transfer all carisoprodol to a DEA registrant who is authorized to possess schedule IV controlled substances on or before January 11, 2012;

c.  Carisoprodol will generally be subject to the security requirements applicable to schedule IV controlled substances as of January 11, 2012.  However, certain storage, manufacturing and freight forwarding security requirements under 21 C.F.R. §§ 1301.72(b) and (c), 1301.73 and 1301.77 are not applicable until April 10, 2012;

d.  Commercial containers of carisoprodol packaged on or after April 10, 2012 must be labeled as “C-IV” and packaged in accordance with 21 C.F.R. §§ 1302.03-.07.  Registrants may distribute commercial containers packaged before April 10, 2012 that do not comply with 21 C.F.R. §§ 1302.03-.07 until June 11, 2012.  All commercial containers of carisoprodol must be labeled as “C-IV” and comply with 21 C.F.R. §§ 1302.03-.07 on or after June 11, 2012;

e.  Registrants who possess any quantity of carisoprodol must take an initial inventory of all stocks on-hand on or before January 11, 2012 and then include carisoprodol in its biennial inventory thereafter;

f.  Registrants who possess any quantity of carisoprodol must maintain all records required for schedule IV controlled substances after January 11, 2012;

g.  All prescriptions for carisoprodol or prescriptions containing carisoprodol must comply with DEA’s controlled substance prescription requirements after January 11, 2012;

h.  Carisoprodol is subject to importation and exportation requirements after January 11, 2012; and

i.  Any activity with carisoprodol that is not authorized by, or that is conducted in violation of, the CSA on or after January 12, 2012, is unlawful.

The VIPPS program and its seal of approval assure the public that VIPPS retailers are legitimate online pharmacies appropriately licensed in each state to which they ship pharmaceuticals. Additionally, VIPPS retailers have successfully completed a rigorous 19-point criteria review and on-site survey. It is the only verification program supported by the Food and Drug Administration and Drug Enforcement Administration.

The VIPPS program is unique in that no other accreditation or verification program for online drug sellers covers as many areas as VIPPS, or does so as thoroughly. It is this criteria, and how it was developed, that sets the VIPPS program apart.

The Industry’s Toughest Standards
An online pharmacy must demonstrate compliance with a stringent set of criteria to qualify for VIPPS accreditation. Along with verification that the pharmacy is licensed in good standing by state boards, the VIPPS criteria includes questions in 19 Internet and practice-based areas, including:

• how the patient’s or caregiver’s identity is verified
• patient medication consultation
• the steps that are taken to ensure the patient’s confidentiality
• how medications are dispensed
• how controlled substance medications are secured and tracked when shipped to the patient.

The VIPPS program was developed by a coalition of state and federal regulatory associations, professional associations, and consumer advocacy groups. Because NABP accredits the online pharmacies based on criteria defined by regulators, consumers, and pharmacists, the public can rely on the VIPPS Seal to be assured that each patient receives the best in online pharmacy care. Currently, 15 pharmacy sites representing more than 12,000 pharmacies carry the VIPPS seal.

The originally proposed bill would allow the U.S. Department of Justice, as well as copyright holders, to seek court orders against websites accused of enabling or facilitating copyright infringement. Depending on who requests the court orders, the actions could include barring online advertising networks and payment facilitators such as PayPal from doing business with the allegedly infringing website, barring search engines from linking to such sites, and requiring Internet service providers to block access to such sites. The bill would make unauthorized streaming of copyrighted content a crime, with a maximum penalty of five years in prison for 10 pieces of music or movies within six months. The bill also gives immunity to Internet services that voluntarily take action against websites dedicated to infringement, while making liable for damages any copyright holder who knowingly misrepresents that a website is dedicated to infringement.

Proponents of the bill say it protects the intellectual property market and corresponding industry, jobs and revenue, and is necessary to bolster enforcement of copyright laws especially against foreign websites. Opponents say that it infringes on First Amendment rights, is Internet censorship, will cripple the Internet, and will threaten whistle-blowing and other free speech.

The House Judiciary Committee held hearings on SOPA on November 16 and December 15, 2011. The Committee is scheduled to continue debate when Congress returns from its winter recess.

Contents

The bill would authorize the U.S. Department of Justice to seek court orders against websites outside U.S. jurisdiction accused of infringing on copyrights, or of enabling or facilitating copyright infringement. After delivering a court order, the U.S. Attorney-General could require US-directed Internet service providers, ad networks, and payment processors to suspend doing business with sites found to infringe on federal criminal intellectual property laws. The Attorney-General could also bar search engines from displaying links to the sites.

The bill also establishes a two-step process for intellectual property rights holders to seek relief if they have been harmed by a site dedicated to infringement. The rights holder must first notify, in writing, related payment facilitators and ad networks of the identity of the website, who, in turn, must then forward that notification and suspend services to that identified website, unless that site provides a counter notification explaining how it is not in violation. The rights holder can then sue for limited injunctive relief against the site operator, if such a counter notification is provided, or if the payment or advertising services fail to suspend service in the absence of a counter notification.

The bill provides immunity from liability to the ad and payment networks that comply with this Act or that take voluntary action to cut ties to such sites. Any copyright holder who knowingly misrepresents that a website is dedicated to infringement would be liable for damages. The second section increases the penalties for streaming video and for selling counterfeit drugs, military materials or consumer goods. The bill would make unauthorized streaming of copyrighted content a felony.

Ramifications

Gary Shapiro, CEO of the Consumer Electronics Association, spoke out strongly against the bill, stating that “The bill attempts a radical restructuring of the laws governing the Internet,” and that “It would undo the legal safe harbors that have allowed a world-leading Internet industry to flourish over the last decade. It would expose legitimate American businesses and innovators to broad and open-ended liability. The result will be more lawsuits, decreased venture capital investment, and fewer new jobs.”

Art Bordsky of advocacy group Public Knowledge similarly stated that “The definitions written in the bill are so broad that any US consumer who uses a website overseas immediately gives the US jurisdiction the power to potentially take action against it.”

According to co-sponsor Representative Bob Goodlatte (R-VA), chairman of the House Judiciary Committee’s Intellectual Property sub-panel, SOPA represents a rewrite of the PROTECT IP Act to address tech industry concerns. Goodlatte told The Hill that the new version requires court approval for action against search engines. The Senate version, PROTECT IP, does not.

A news analysis in the information technology magazine eWeek stated, “The language of SOPA is so broad, the rules so unconnected to the reality of Internet technology and the penalties so disconnected from the alleged crimes that this bill could effectively kill e-commerce or even normal Internet use. The bill also has grave implications for existing U.S., foreign and international laws and is sure to spend decades in court challenges. SOPA is the House version of a Senate bill called the Protect IP Act (S. 968) that is very different. As a result, both bills if passed in something resembling their current states will have to be considered by a conference committee.”

Technical concerns

It has been argued that open source software projects may shut down under this bill, under a provision which the EFF believes targets Mozilla, the browser used for about a quarter of all web searches. Mozilla refused in early 2011 to pull the Mafiaafire add-on from its website, asking “Have any courts determined that the Mafiaafire add-on is unlawful or illegal in any way?”

“It would cover IP blocking. I think it contemplates deep packet inspection” said Markham C. Erikson, head of NetCoalition, a group that includes Google, Yahoo and eBay. An aide to sponsor Lamar Smith said that the judge would decide what sort of blocking to order. Cary Sherman, Chairman and CEO of the RIAA wrote in a guest editorial for CNET that the proposed law targeted “only the illegal subdomain or Internet protocol address rather than taking action against the entire domain.” (sic)

Americans may simply switch to offshore DNS providers such as CloudFloor who offer encrypted links, said David Ulevitch, the San Francisco-based head of OpenDNS. U.S. entrepreneurs might also move offshore. “We can reincorporate as a Cayman Islands company and offer the same great service and not be a U.S. company anymore”, he said.

Andrew Lee, CEO of ESET North America, has expressed concerns that since the bill would require internet service providers to filter DNS queries for the sites, this would undermine the integrity of the Domain Name System. On November 17, 2011, Ars Technica reported the appearance of a new anonymous top-level domain, Dot-BIT (.bit), outside of ICANN control.

Edward J. Black, president and CEO of the Computer and Communications Industry Association, wrote in the Huffington Post that “Ironically, it would do little to stop actual pirate websites, which could simply reappear hours later under a different name, if their numeric web addresses aren’t public even sooner. Anyone who knows or has that web address would still be able to reach the offending website.”

Bill targets more than infringing website

A Center for Democracy and Technology paper says that the bill “targets an entire website even if only a small portion hosts or links to some infringing content.” Answering similar criticism in a CNET editorial, RIAA head Cary Sherman wrote: “Actually, it’s quite the opposite. By focusing on specific sites rather than entire domains, action can be targeted against only the illegal subdomain or Internet protocol address rather than taking action against the entire domain.”

According to A.M Reilly of Industry Leaders Magazine, under SOPA, culpability for distributing copyright material is extended to those who aid the initial poster of said material. For companies that use virtual private networks to create a network that appears to be internal but is spread across various offices and employees homes, any of theses offsite locations that initiate sharing of copyright material can put the entire VPN and hosting company at risk of violation.

DNS blocking and filtering

The Domain Name System (DNS) servers, most often equated with a phone directory, translate browser requests for domain names into the IP address assigned to that computer or network. The bill requires these servers to stop referring requests for infringing domains to their assigned IP addresses.

Representative Zoe Lofgren, Democrat, whose district includes part of Silicon Valley, and who has called the bill “the end of the internet as we know it”, on November 17 released and posted to her website a technical assessment she requested from Sandia National Laboratories of the House and Senate bills. Neither would effectively control piracy and they would delay implementation of DNSSEC, her statement said, summarizing Sandia’s response. Sandia National Laboratories is an agency of the US Department of Energy that does nuclear, computer, and military research.

The Sandia letter mostly agrees with a white paper criticizing the DNS provisions of the Senate bill. It disagrees with the contention of harm to DNSSEC implementation because, it says, DNSSEC remains so far mostly unimplemented although the need for it is clear.

An editorial in the San Jose Mercury-News agreed with Lofgren’s statement that the bill would mean “the end of the internet as we know it”, stating, “Imagine the resources required to parse through the millions of Google and Facebook offerings every day looking for pirates who, if found, can just toss up another site in no time.”

Center for Democracy and Technology lawyers David Sohn and Andrew McDiarmid, in an article for The Atlantic, wrote, “In addition to domain-name filtering, SOPA would impose an open-ended obligation on Internet Service Providers (ISPs) to prevent access to infringing sites…Preventing access to specific sites would require ISPs to inspect all the Internet traffic of its entire user base—the kind of privacy-invasive monitoring that has come under fire in the context of ‘deep packet inspection’ for advertising purposes.”

A white paper by several internet security experts, including Steve Crocker and Dan Kaminsky, wrote, “From an operational standpoint, a resolution failure from a nameserver subject to a court order and from a hacked nameserver would be indistinguishable. Users running secure applications have a need to distinguish between policy-based failures and failures caused, for example, by the presence of an attack or a hostile network, or else downgrade attacks would likely be prolific.”

Internet security and DNSSEC

There have been concerns raised that SOPA would harm the usefulness of the Domain Name System Security Extensions (DNSSEC), a set of protocols developed by the Internet Engineering Task Force (IETF) for ensuring internet security. A white paper by the Brookings Institution wrote that “The DNS system is based on trust,” adding that DNSSEC was developed to prevent malicious redirection of DNS traffic, and that “other forms of redirection will break the assurances from this security tool.”

House cybersecurity subcommittee chairman Dan Lungren told Politico’s Morning Tech that he had “very serious concerns” about SOPA’s impact on the Internet security protocol, DNSSEC, adding “we don’t have enough information, and if this is a serious problem as was suggested by some of the technical experts that got in touch with me, we have to address it. I can’t afford to let that go by without dealing with it.”

Detection considerations

Google voluntarily blocks child pornography using methods that begin by detecting fleshtones, said Google representative Katherine Oyama at the November 16 hearing, but does not know how to detect copyright infringement. Under current law, Google must rely on copyright holders to bring offending material to its attention.

Legal concerns

According to some opponents, its requirements would overturn the Digital Millennium Copyright Act’s (DMCA) process requiring copyright owners to submit notices of infringement to websites and ask for the infringing material to be taken down, legal observers say. “If any website sets itself up in a way that does not actively log or monitor user behavior, a rights holder can always allege that the site is “avoiding confirming” the use of the site for infringement. That rights holder allegation is sufficient to put the website at major risk of losing access to payment and ad networks,” said CDT lawyer David Sohn.

Provider suspensions will likely target entire accounts, said the Electronic Frontier Foundation, and the bill’s provisions “grant them immunity for choking off a site if they have a ‘reasonable’ belief that a portion of a site enable(s) infringement, (and) give the payment processors a strong incentive to cut them off anyway.”

Law professor Jason Mazzone wrote, “Damages are also not available to the site owner unless a claimant ‘knowingly materially’ misrepresented that the law covers the targeted site, a difficult legal test to meet. The owner of the site can issue a counter-notice to restore payment processing and advertising but services need not comply with the counter-notice”.

Effect on web businesses

Harvard Business Review blogger James Allworth wrote, “Is this really what we want to do to the internet? Shut it down every time it doesn’t fit someone’s business model?” concluding that the bill would “give America its very own version of the Great Firewall of China.”

Christian Dawson, COO of Virginia-based hosting company ServInt, predicted that the legislation would lead to many cloud computing and Web hosting services moving out of the US to avoid lawsuits: “I see SOPA as a stimulus package for Asia and Europe and their Internet economies,” he said.

Conversely, Michael O’Leary of the MPAA argued at the November 16 Judiciary Committee hearing that the act’s effect on business would be more minimal, noting that at least 16 countries block websites, and the internet still functions in those countries. Denmark, Finland and Italy block The Pirate Bay after courts ruled in favor of music and film industry litigation, and a coalition of film and record companies has threatened to sue British Telecom if it does not follow suit. Maria Pallante of the US Copyright Office said that Congress has updated the Copyright Act before and should again, or “the U.S. copyright system will ultimately fail.” Asked for clarification, she said that the US currently lacks jurisdiction over websites in other countries.

Copyright

Goodlatte stated, “Intellectual property is one of America’s chief job creators and competitive advantages in the global marketplace, yet American inventors, authors, and entrepreneurs have been forced to stand by and watch as their works are stolen by foreign infringers beyond the reach of current U.S. laws. This legislation will update the laws to ensure that the economic incentives our Framers enshrined in the Constitution over 220 years ago – to encourage new writings, research, products and services – remain effective in the 21st Century’s global marketplace, which will create more American jobs. The bill will also protect consumers from dangerous counterfeit products, such as fake drugs, automobile parts and infant formula.”

Rights-holders see intermediaries as the only accessible defendants. “This is the last stand—the guys who have the pipes,” says Peter Mensch of Q Prime, which represents bands such as Metallica and the Red Hot Chili Peppers.

Brooklyn Law School professor Jason Mazzone warned, “Much of what will happen under SOPA will occur out of the public eye and without the possibility of holding anyone accountable. For when copyright law is made and enforced privately, it is hard for the public to know the shape that the law takes and harder still to complain about its operation.”

DMCA

Critics of the bill, including Google, have expressed concern about the bill’s effect on provisions of the existing Digital Millennium Copyright Act which protect Internet companies that act in good faith to remove user-uploaded infringing content from their sites.

Goodlatte added, “We’re open to working with them on language to narrow [the bill's provisions], but I think it is unrealistic to think we’re going to continue to rely on the DMCA notice-and-takedown provision. Anybody who is involved in providing services on the Internet would be expected to do some things. But we are very open to tweaking the language to ensure we don’t impose extraordinary burdens on legitimate companies as long as they aren’t the primary purveyors [of pirated content]“. The DMCA provision known as safe harbor protects YouTube and other sites such as social networks hosting uploaded user material from liability, provided the sites promptly remove infringing material brought to their attention, removing “the risk that the few users among millions who post copyrighted material, libelous statements or counterfeit goods would subject the site to business-crushing legal liabilities.”

The MPAA’s O’Leary submitted written testimony in favor of the bill that expressed guarded support of current DMCA provisions. “Where these sites are legitimate and make good faith efforts to respond to our requests, this model works with varying degrees of effectiveness,” O’Leary wrote. “It does not, however, always work quickly, and it is not perfect, but it works.”

The EFF has warned that Etsy, Flickr and Vimeo all seem likely to shut down if the bill becomes law. According to critics, the bill would ban linking to sites deemed offending, even in search results and on services such as Twitter.

Jobs and the economy

On October 28, 2011, the EFF called the bill a “massive piece of job-killing Internet regulation,” and said, “This bill cannot be fixed; it must be killed.”

Sponsor Rep. John Conyers (D-MI) said, “Millions of American jobs hang in the balance, and our efforts to protect America’s intellectual property are critical to our economy’s long-term success.” Smith added, “The Stop Online Piracy Act helps stop the flow of revenue to rogue websites and ensures that the profits from American innovations go to American innovators.”

The MPAA representative who testified before the committee said that the motion picture and film industry supports two million jobs and 95,000 small businesses. A study in early 2011 found that the internet created 2.6 jobs for every job lost to it and that “in the mature countries we studied, the Internet accounted for 10% of GDP growth over the past 15 years. And its influence is expanding. Over the past five years, the Internet’s contribution to GDP growth has doubled to 21 percent.”

“Total U.S. commerce in 2008 (the latest year reported on) was about $22 trillion. Of this about $3.7 trillion was in the form of e-commerce, mostly over the Internet. Most of this (92%) was business-to-business,” said Harvard University’s Technology Security Officer Scott Bradner, citing census data in a discussion of the economic effects of net neutrality. US Department of Commerce figures for the third quarter of 2011 show a 13.7 percent increase for e-commerce from the third quarter of 2010 and a total retail sales increase of 8.2 percent for the same period. E-commerce sales in the third quarter of 2011 accounted for 4.6 percent of total sales, according to the Commerce announcement.

Startups and venture capital

Lukas Biewald, founder of CrowdFlower, stated that “It’ll have a stifling effect on venture capital. The venture capitalists have been pretty vociferous opponents of this bill. If it’s making investors nervous, that’s bad for me and other startup founders. No one would invest because of the legal liability.”

Booz & Company on November 16 released a study finding that almost all of the 200 venture capitalists and angel investors interviewed would stop funding digital media intermediaries if the House bill becomes law. More than 80 percent said they would rather invest in a risky, weak economy with the current laws than a strong economy with the proposed law in effect. If legal ambiguities were removed and good faith provisions in place, investing would increase by nearly 115 percent. The study was funded by Google and researched and written by Booz.

Counterfeit and misbranded drug industry

John Clark, spokesman for Pfizer, testified at the committee hearing that patients could not always detect cleverly forged websites selling drugs that were either misbranded or simply counterfeit. RxRights, a consumer advocacy group, issued a statement saying that Clark failed “to acknowledge that there are Canadian and other international pharmacies that do disclose where they are located, require a valid doctor’s prescription and sell safe, brand-name medications produced by the same leading manufacturers as prescription medications sold in the U.S.” They had earlier said that SOPA “fails to distinguish between counterfeit and genuine pharmacies” and would prevent American patients from ordering their medications from Canadian pharmacies online.

Bill sponsor Lamar Smith (R-TX) accused Google of obstructing the bill, citing its $500 million settlement with the DoJ of charges that it allowed ads from Canadian pharmacies, leading to illegal imports of prescription drugs. “Given Google’s record, their objection to authorizing a court to order a search engine to not steer consumers to foreign rogue websites is more easily understood,” Smith said at the hearing. “Unfortunately, the theft of America’s IP costs the U.S. economy more than $100 billion annually and results in the loss of thousands of American jobs.” Shipment of prescription drugs from foreign pharmacies to customers in the US typically violates the Federal Food, Drug and Cosmetic Act and the Controlled Substances Act, whether or not the drugs or the pharmacies are legitimate.

Free speech concerns

In an op-ed by Rebecca MacKinnon, she argued that making companies liable for users’ actions could have a chilling effect on user-generated sites like YouTube. “The intention is not the same as China’s Great Firewall, a nationwide system of Web censorship, but the practical effect could be similar”, she says.

According to the EFF, proxy servers, such as those used during the Arab Spring, can also be used to thwart copyright enforcement and therefore may be made illegal by the act.

On Time’s Techland blog, Jerry Brito wrote, “Imagine if the U.K. created a blacklist of American newspapers that its courts found violated celebrities’ privacy? Or what if France blocked American sites it believed contained hate speech? We forget, but those countries don’t have a First Amendment.” Similarly, the Center for Democracy and Technology warned, “If SOPA and PIPA are enacted, the US government must be prepared for other governments to follow suit, in service to whatever social policies they believe are important—whether restricting hate speech, insults to public officials, or political dissent.”

The AFL-CIO’s Paul Almeida, arguing in favor of SOPA, stated that free speech was not a relevant consideration, because “The First Amendment does not protect stealing goods off trucks.”

On November 18, 2011 the European parliament adopted by a large majority a resolution that “stresses the need to protect the integrity of the global Internet and freedom of communication by refraining from unilateral measures to revoke IP addresses or domain names.”

CNET correspondent Larry Downes wrote, “A bill that was to target only the ‘worst of the worst’ foreign Web sites committing blatant and systemic copyright and trademark infringement has morphed inexplicably into an unrestricted hunting license for media companies to harass anyone foreign or domestic—who questions their timetable for digital transformation.”

Penalties for illegal streaming

An aide to bill sponsor Lamar Smith has said, “This bill does not make it a felony for a person to post a video on YouTube of their children singing to a copyrighted song. The bill specifically targets websites dedicated to illegal or infringing activity. Sites that host user content—like YouTube, Facebook, and Twitter—have nothing to be concerned about under this legislation”.

Lateef Mtima, Director of the Institute for Intellectual Property and Social Justice at the Howard University School of Law expressed concern with the bill’s language, saying, “Perhaps the most dangerous aspect of the bill is that the conduct it would criminalize is so poorly defined. While on its face the bill seems to attempt to distinguish between commercial and non-commercial conduct, purportedly criminalizing the former and permitting the latter, in actuality the bill not only fails to accomplish this but, because of its lack of concrete definitions, it potentially criminalizes conduct that is currently permitted under the law.”

Mtima continued, “The Senate version requires that a video has more than ’10 performances’, which legal experts say is equivalent to ‘views’. In the House version, only 1 view is required. In the House version, the market value of licensing the work only needs to be $1,000 (a merely nominal licensing fee for any popular music) or greater to qualify as a criminal offense.”

In response to public concern of the safety of pharmacy practices on the Internet, the association developed the Verified Internet Pharmacy Practice Sites (VIPPS) program in the spring of 1999. A coalition of state and federal regulatory associations, professional associations, and consumer advocacy groups provided their expertise in developing the criteria which VIPPS accredited Pharmacies follow.

To be VIPPS accredited, a pharmacy must comply with the licensing and inspection requirements of their state and each state to which they dispense pharmaceuticals. In addition, pharmacies displaying the VIPPS seal have demonstrated to NABP compliance with VIPPS criteria including patient rights to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists.

VIPPS pharmacy sites are identified by the VIPPS hyperlink seal displayed on their Web site. By clicking on the seal, a visitor is linked to the NABP VIPPS site where verified information about the pharmacy is maintained by NABP. The public is also welcome to access the VIPPS site at www.nabp.net to search for a VIPPS Internet pharmacy, which matches their needs.

LegitScript was founded by John Horton, who was a White House aide on drug policy issues from 2002 to 2007. The organization’s main office was initially located in Arlington, Virginia, but is currently identified as being in Portland, Oregon. The company is identified by the Alliance for Safe Online Pharmacies as a founding member.

In July 2008, LegitScript and KnujOn released a report about 150 websites that offer to sell anabolic steroids over the Internet without requiring a prescription. This report was also featured in the New York Times, as well as on CNN’s Anderson Cooper 360. The report resulted in the termination of large underground steroids rings and controversy at pro-steroids forums. LegitScript and KnujOn also released two reports analyzing Microsoft and Yahoo sponsored search results for Internet pharmacies. Subsequently, Google, Yahoo and Microsoft announced that they were updating their advertising policies related to Internet pharmacies, and would in the future require that Internet pharmacies be approved by the National Association of Boards of Pharmacy’s VIPPS program. Shortly thereafter, LegitScript announced that it would be helping Google implement the new policy by monitoring all prescription drug and pharmacy ads for the search engine.

In November 2008, LegitScript reported that it had shut down 500 “rogue” Internet pharmacies by notifying their ISPs and domain registrars. In May 2010, the company released a report regarding over 7,000 displaying a forged pharmacy license, indicating that it worked with 11 different domain name registrars to shut down the websites.

In March 2010, consumer protection website SiteJabber announced that it would begin integrating LegitScript’s legitimacy determinations into its Internet pharmacy ratings. In May 2010, the Web of Trust (MyWot) announced a similar initiative in which LegitScript Internet pharmacy legitimacy determinations would be integrated into MyWOT’s reputation rankings.

As of September 2010, LegitScript’s website indicated that LegitScript had approved over 320 online pharmacy websites as meeting LegitScript’s standards, and documented over 48,000 “rogue” online pharmacy websites.

• 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.
• Importation of an unapproved prescription drug (not necessarily a controlled substance) violates 21 USC, Section 301(aa), even for personal use. The Food, Drug, and Cosmetic Act does allow for the importation of drug products for unapproved new drugs for which there is no approved American version. However, this allowance does not allow for the importation of foreign-made versions of U.S. approved drugs.
• The law further specifies that enforcement should be focused on cases in which the importation by an individual poses a threat to public health, and discretion should be exercised to permit individuals to make such importations in circumstances in which the prescription drug or device imported does not appear to present an unreasonable risk to the individual.
• It is also illegal to import non-approved drugs (21 USC sections 331(d) and 355(a)); however, FDA policies suggest that, under certain circumstances, patients may be allowed to keep these drugs.
• Individual U.S. states may implement their own laws regulating importation, possession, and trafficking in prescription drugs and/or controlled substances.
  
• For several years, the states of Nevada, Minnesota, Illinois and Wisconsin have run official state programs to help their residents order lower-cost drugs from abroad to save money.
  

Enforcement

• Any package containing prescription drugs may be seized by US Customs and Border Protection. The package may be held and eventually returned to the sender if the addressee does not respond and provide proof that they are allowed to receive these drugs (e.g., a valid prescription). In practice, the number of packages containing prescription drugs sent to United States on a daily basis far exceeds CBP’s capabilities to inspect them. In the past, packages often passed through customs even if they were not sent from Canada or otherwise didn’t meet the requirements of section 804 of 21 USC. Until recently, about 5 percent of prescription drug packages sent from Canada were being seized.
• DEA and FDA generally do not target consumers unless drugs are imported in large quantities (suggesting intent to distribute) or represent a perceived danger to public health (opiates, amphetamines).
• Rarely, drug importation laws are enforced on the local level. For example, in June 2005 in Baton Rouge, Louisiana, a number of customers of online pharmacies were arrested by local law enforcement officers and charged with possession of a controlled substance without prescription.

The Washington Post reported that “…millions of Americans have turned to Mexico and other countries in search of bargain drugs…U.S. Customs estimates 10 million U.S. citizens bring in medications at land borders each year. An additional 2 million packages of pharmaceuticals arrive annually by international mail from Thailand, India, South Africa and other points. Still more packages come from online pharmacies in Canada.”

Some people in the US, including some legislators, favor accessing foreign-made prescription drugs to lower Americans’ health costs. According to a Wall Street Journal/Harris Online poll in 2006, 80 percent of Americans favor importing drugs from Canada and other countries. President Obama’s budget supports a plan to allow people to buy cheaper drugs from other countries. A report in the journal Clinical Therapeutics found that U.S. consumers face a risk of getting counterfeit drugs because of the rising Internet sales of drugs, projected to reach $75 billion by 2010.

In the United States, there are two verification programs for online pharmacies that are recognized by the National Association of Boards of Pharmacy (NABP). One is the Verified Internet Pharmacy Practice Sites Program (VIPPS), which is operated by the NABP and was created in 1999. The Food and Drug Administration refers Internet users interested in using an online pharmacy to the VIPPS program. The other is LegitScript, which as of September 2010 had approved over 340 Internet pharmacies as legitimate and identified over 47,000 “rogue” Internet pharmacies.

While many internet pharmacies sell prescription drugs only with a prescription, some do not require a pre-written prescription. In some countries, this is because prescriptions are not required. Some customers order drugs from such pharmacies to avoid the inconvenience of visiting a doctor or to obtain medications their doctors were unwilling to prescribe. People living in the United States and other countries where prescription medications are very expensive may turn to online pharmacies to save money. Many of the reputable websites employ their own in-house physicians to review the medication request and write a prescription accordingly. Some websites offer medications without a prescription or a doctor review. This practice has been criticized as potentially dangerous, especially by those who feel that only doctors can reliably assess contraindications, risk/benefit ratios, and the suitability of a medication for a specific individual. Pharmacies offering medication without requiring a prescription and doctor review or supervision are sometimes fraudulent and may supply counterfeit—and ineffective and possibly dangerous—medicines.