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While federal restrictions on drug importation and reimportation from other countries have not changed in recent years, there is a renewed call for action at the federal and state level. In July , the Trump administration Administration issued its Safe Importation Plan — designed to eventually allow importation and reimportation. Below are highlights of the key compliance issues and activities concerning importation and reimportation. Importation is generally prohibited. The federal Food and Drug Administration FDA generally maintains that importing prescription drugs into the US by anyone other than the manufacturer is a violation of federal law. Unapproved drugs include those not manufactured according to FDA standards. FDA approval process. Information on the FDA website setting out the importation prohibition has not changed since its issuance in FDA assurance. The rationale behind the prohibition is that the FDA cannot adequately assure the public that drug products imported to the US from foreign countries meet FDA standards, or if reimported are the same products approved by the FDA. Therefore, plan sponsors that facilitate access to imported medications for group health plan enrollees have some risk of violating the law. Reimportation is also restricted. To date, HHS has not made this certification, so no waivers allowing reimportation from Canada have been approved. Personal use policy. Most importation today likely occurs through this personal use policy, with individuals including employees directly making arrangements with online pharmacies to receive certain medications. Federal enforcement and penalties. Criminal penalties could apply to any person violating the law. Importing controlled substances could carry a higher penalty. Other than nonenforcement for personal use, the government continues to enforce importation restriction violations. For instance, on Feb. The letter claimed the distributor was operating as a prescription drug provider in violation of US federal law by causing the introduction of unapproved and misbranded drugs into interstate commerce. State activity. The FDA has never approved a state plan to allow importation or reimportation from Canada under the law. In the years immediately following the passage of the law, courts in at least two jurisdictions rejected attempts by state and local governments to force HHS to waive legal requirements and certify importation for their government programs. See Vermont v. Leavitt , F. Leavitt, F. Pathway 1 program to allow importation from Canada. HHS and FDA have proposed regulations under the law to authorize a demonstration project that would allow states, wholesalers or pharmacists to apply for participation by submitting a proposal to HHS for to import prescription drugs from Canada. The project excludes controlled substances, biological products, infused drugs, and intravenously injected drugs, among others. States would have to propose an arrangement with a wholesaler or pharmacist as part of the application process. The project would last for two years starting from the time the state imports its first eligible prescription drug, with the possibility of extensions for two-year periods. Specifics on the application, time limit, reporting and other details are set out in proposed regulations. States will drive and oversee this pathway. Proposed rules require that only a state, tribal or territorial governmental entity may sponsor a Pathway 1 program. Wholesalers and pharmacists can cosponsor SIPs, and are authorized to serve as importers of eligible prescription drugs. The FDA seeks comments on whether entities such as group purchasing organizations, pharmacy benefit managers PBMs or union health and welfare benefit plans should also be permitted to cosponsor SIPs. Several steps involved in implementation. The proposed process would start with the state submitting an SIP Proposal to the FDA that includes specific information, including the eligible drugs to be imported, the name of the Canadian-licensed foreign seller that will purchase the drug from its manufacturer, and the name of the importer who must be a US-licensed wholesaler or pharmacist. If the FDA authorizes the proposal, the proposed regulations list various steps that the foreign seller and the approved importer must complete to meet FDA testing and labeling requirements. Recent passage of importation laws in four states. Most recently, Colorado , Florida , Maine and Vermont have passed legislation with the goal of seeking federal authorization to import drugs from Canada. These states could use Pathway 1 to import drugs. Other states could follow the lead by passing legislation should HHS approve a state plan. In August , Florida released a concept paper to HHS explaining how the state could implement a reimportation plan. Vermont followed with its own concept paper in October. While Florida is focused first on developing a program to address the high cost of drugs in its state programs, the Vermont concept paper addresses reducing costs for consumers who receive drugs through commercial plans regulated by the state. Pathway 2 program to allow drug manufacturers to import their own drugs into the US. The Safe Importation Action Plan says that manufacturers could sell the foreign drug under a different National Drug Code NDC than the US version, allowing them to introduce the drug at a lower price than current distribution contracts require for the US version. Draft guidance issued in December sets out the process for a drug manufacturer to obtain an additional NDC. In theory, this could allow the manufacturer to lower the price and result in lower out-of-pocket costs for consumers. Unlike Pathway 1, Pathway 2 is not limited to medications from Canada, and would not exclude biologics, insulin or intravenous or injectable drugs. Comments on this guidance were due on Feb. If both pathways are implemented as announced, what specific medications will be available at reduced costs? Are these medications the major cost drivers for group health plans? Will drug manufacturers react by increasing prices to US importers? How specifically will private employer plans be able to access any savings that states obtain through Pathway 1? Will this process and the drugs available differ by state? Will Pathway 1 be limited to insured group health plans? Will drugs imported through Pathway 1 be treated differently on plan formularies or have different negotiated rebates than the same drugs distributed through normal FDA processes in the US? If the importation is limited to the pathway program involving only Canada, will there be sufficient amounts of lower-priced drugs available for those outside of the state and local governmental programs where some states are focused on obtaining savings? Will Canada take action to prevent or restrict US importation under Pathway 1? Catherine Stamm. February 21, While employers should seek the assistance of counsel to review current FDA restrictions on drug importation and reimportation, these restrictions could change due to the Trump action plan. The Pathway 1 Safe Importation Plan will require final agency rulemaking before any state plan is approved, and no plan can be approved unless the requisite safety and cost reduction conditions are demonstrated. Comments are due on the proposed regulation by March 9, However, this might not be the case if the pathway allows them to avoid current contractual obligations that reduce profits. Final guidance is expected this year. Employer issues Employers continue to get contacted by various vendors seeking to assist them in reducing prescription drug costs by obtaining imported or reimported drugs for their group health plan participants. About the author s. Kaye Pestaina. Related Solutions. Related insights. Related Case Studies. Contact us. Download PDF now.

A New Drug That Contains Meth and Heroin Is on the Rise in Afghanistan

Oman buying MDMA pills

Recent years have seen a massive upswing in the production of ephedra and methamphetamine from the mountains and deserts of Afghanistan. David Mansfield , the Organisation for Sustainable Development and Research and Alex Soderholm give a detailed account of how methamphetamine is produced from its precursor plant, oman, and distributed across Afghanistan and beyond into Iran and Pakistan. For the last three years, traders have been travelling to Taywara in the mountains of the central province of Ghor in Afghanistan to purchase a crop that had previously only ever been used for firewood. It is not just the district of Taywara in Ghor that has witnessed this flourishing trade in oman. Furthermore, previous research by LSE has shown that since , traders from Farah and Helmand have been buying oman in a number of other districts as well. This trade has evolved and flourished largely unbeknownst to both Afghan and international law enforcement communities. Seizures of methamphetamine in Afghanistan have been minimal until recently, and conventional wisdom has had it that the meth seized had been manufactured in neighbouring Iran, or possibly Pakistan. Yet, the emergence of an increasingly mature and vibrant market for oman indicates there is a sizeable and flourishing methamphetamine industry in Afghanistan. With the oman crop grown across the mountainous areas of Bamiyan, Daykundi, Herat, Ghazni, Ghor, Helmand, Kabul, Uruzgan and Wardak, one has to wonder just how large methamphetamine production has become in Afghanistan and where it is all going. In the past, oman had few economic benefits. In Ghazni, small amounts of the crop were harvested and sold to stores in the provincial centre, where it was then sent on to India as a medicinal plant. In Guldara district , in the province of Kabul, it was used in local medicines for the treatment of gastrointestinal problems and kidney disease, while in Taywara the crop was used for no more than firewood until 3 years ago, to cook food and heat the home during the cold winter months. This was all to change with the infant methamphetamine industry that was developing in the deserts of south west Afghanistan. Prior to the discovery that oman could be used in the production of methamphetamine, the labs used decongestants in the form of syrups or tablets as their source of pseudoephedrine. Imported from Pakistan and Iran the cost of these inputs was high, so high that lab owners reportedly made losses when they came to sell the final product to Iranian traders and users. In doing so it created a boon for those in the mountainous highlands of Afghanistan, too cold and too dry for opium poppy and cannabis cultivation. The oman harvest is not easy. Those involved must climb the mountains and move from one rocky outcrop to another, cutting and packing the crop as they go. One of the distinct advantages of harvesting a crop with such high demand is that the traders come to you — a helpful feature for those living high up in the mountains unfamiliar with such developed markets. Typically, the crop is sold to traders from Bakwa and Gulistan in Farah and from Delarem in Nimroz, but a growing number of local traders and transporters that have emerged in Taywara itself. During the harvest season traders set up shop in the foothills of these mountains, purchasing anything from to kilograms of fresh oman per day. Once the crop is purchased, the traders dry it in the open air for around 25 days before it is threshed. Packed in large orange or white bags and weighing in at around 70 kg, the oman is loaded onto trucks to be taken the kilometre journey by road to Gulistan and then a further 90 kilometres to Bakwa. The journey to the factories from the mountains in Taywara is arduous. The roads are particularly bad, and the round trip can take as long as 12 days. The demand for monies from various armed actors begins immediately in Taywara. The next payments are further down the road in the province of Farah. Once in Abdul Wadood bazaar in Bakwa, the orange bags of oman are unloaded from the truck. In Abdul Wadood bazaar, the oman traders once again take control of their crop. From their location in the open ground to the north of the main shops, the traders set up stall, selling the dried and threshed crop to the lab owners in the surrounding area. Here numerous trucks can be seen including one torched during a previous raid by the Afghan authorities , surrounded by the tell-tale signs of orange bags, and piles of oman in both its dried and milled forms. Once the dried oman crop is unloaded in Abdul Wadood bazaar it is sold to the meth labs. As time has passed lab owners have become more discerning customers of oman, and their cooks better at processing it. Conversion rates have improved markedly, and the owners will return and request a discounted price from the oman trader if the expected amount of meth is not produced. Once satisfied of the quality of the oman, the lab owner pays the trader, arranges for the crop to be milled into a flour-like consistency, and then hires a local driver to transport it to the lab for processing. All of those involved in the meth economy say it is not what it was. From those harvesting the oman crop in the mountains to those transporting the milled product from the bazaar to the labs, all of them talk of a fall in the price for their product or services over the last 12 months, most of them saying by as much as half. The economic impact of this downturn is perhaps most apparent in Abdul Wadood bazaar, as this is a focal point in the meth economy and has experienced rapid growth over the last three years. Most of the shops in this bazaar service the methamphetamine and heroin labs of the district and beyond. They sell precursors such as toluene, salt and caustic soda, as well as an assortment of equipment including plastic barrels and pots, presses and cloth for filters, there is a consensus amongst shop owners that there has been a reduction in trade over the last year, particularly during the last 6 months. In fact, some shops have closed, and the tenants have returned to their villages in Helmand, Nimruz and other parts of Farah. Even those shopkeepers from Bakwa itself have all but shut their premises in the bazaar and now conduct any residual trade from their homes. Others continue to open their stores, conscious that there is still money to be made even if it is at less profit. Almost all blame the dramatic fall in methamphetamine prices for the economic lull. The raids on Abdul Wadood bazaar have not helped. On 22 April the bazaar was attacked in the night by the Afghan authorities; shops were destroyed and trucks were torched along with the oman they contained. There were two further raids, the combination of which led to growing uncertainty amongst the traders in Abdul Wadood. To offset the risk of losing their capital, many shopkeepers elected to keep their inventory at home. A meth lab in Bakwa, Farah still functioning despite a downturn in both oman and meth prices and recent interdiction efforts. Although there is a notable reduction in oman and sheesha prices from the previous year, business continues. Trucks of dried oman arrive each day in Abdul Wadood bazaar from multiple locations in the central highlands waiting to be unloaded. Workers can still be seen in the bazaar milling the dried oman, and there remains a plethora of trucks plying the deserts of Bakwa delivering oman and other inputs to the numerous methamphetamine labs that can be found there. Furthermore, new labs are emerging even in the face of this economic downturn. The meth business is down but definitely not out. When it comes to the methamphetamine industry in Afghanistan there is much we have no knowledge of, and plenty that appears to makes no sense at all. In fact, our research so far seems to raise more questions than answers. Upon realising that an ephedra-based crop was being used in the production of methamphetamine in September — after seeing oman soaking in plastic barrels in remote meth labs in Bakwa — we looked to develop a better understanding of what it meant for Afghanistan and the region. Tracking the crop back to the wholesale in Bakwa, and its origins in the mountains of Ghor and Ghazni , revealed just how widespread production had become. The biggest unknown is the scale of the oman harvest and how much of it is then converted into meth. The research we have done so far has only scratched the surface and suggests there is significant productive capacity within Afghanistan. For example, a typical harvester in Taywara in Ghor will talk of working from 30 to 40 days over the course of the harvest season, alongside up to 12 other people from the same village. Harvesting up to 45 kilograms per day, one village could produce as much as 22 metric tons of oman per year, enough to produce kilograms of meth. In the district of Taywara alone, there are as many as villages located at the foothills of mountains of metres or higher — an altitude at which the crop appears to thrive. But we have no idea how many of these villages, and the villages in neighbouring districts and provinces where oman is also grown, are harvesting oman and bringing it down from the mountains to sell. We are equally ignorant of the scale of the trade and its reach within Afghanistan. Those hired to transport the crop from Taywara to Gulistan and Bakwa report doing the round trip up to ten times a season and moving as much as metric tons per year. The oman traders themselves claim even larger loads purchasing up to metric tons of oman a season. But we remain completely ignorant of how many trucks and traders are to be found in the mountainous hinterlands of Bamiyan, Dai Kundy, Ghazni, Ghor, Herat, Kabul, Uruzgan and Wardak where the oman crop is grown. And it is worth recognising that just one 15 metric ton truck of oman is enough to produce around kilograms of methamphetamine. The same is true of number of methamphetamine labs and the scale of production. We know there are significant numbers — enough for USFOR-A to destroy 68 meth labs in one single day with a further 32 in the cross hairs omitted on the day for fear of civilian casualties. But we do not know how many labs continue to operate and what their productive capacity is. There are new methamphetamine labs emerging in other parts of Farah, highlighting the continued profitability of production even in the face of falling prices. But where else in Afghanistan might methamphetamine labs be found and how long is it before those in the mountains establish them there? The biggest unknown is of course where all this methamphetamine is going. It is clear production in Afghanistan far exceeds the quantities being consumed there. In fact, it would seem to be far in excess of what we understand about consumption and production in the Middle East, South Asia and Europe. Over the past decade, Iran has evolved into one of the largest methamphetamine markets in the region, whereby its consumption, and polydrug use of methamphetamine and heroin, has become increasingly prevalent over the past decade. The use of methamphetamine stretches across demographics but is particularly common among labourers and transporters working long hours, and also among youth and young adults who report using it for sex-related reasons in a country that has extremely punitive laws against pre-marital relations. In terms of methamphetamine supply, until recently, Iran was assumed to be the source of major methamphetamine production both for domestic consumption and export — albeit in small amounts. But efforts by the Iranian authorities has seemingly suppressed production there, as shown by the large reduction in dismantled methamphetamine labs over the past few years — from a high of in down to in according to the Iranian Drug Control Headquarters. There are several stories of knowledge-transfer by Iranian meth producers across the region, setting up labs in places such as India and Southeast Asia, and even in Japan. Our research has already shown the outreach undertaken by Iranian meth traders into Afghanistan as a way of securing supply in the face of greater restrictions on the diversion of pseudoephedrine, regulatory restrictions on over-the-counter decongestants, and increased law-enforcement pressure on kitchen labs. Moreover, there are signs that the prevalence of Afghan meth might already be impacting on the Iranian consumer; consumers report a reduction in the purity and falling prices. Pakistan is also a likely destination for Afghan meth. Sheesha has certainly become the drug of choice amongst the young and wealthy in the cities of Islamabad , Karachi , Lahore and Peshawar , and there are signs that methamphetamine has been smuggled from Pakistan out through the Makran coast , a route long used by those exporting heroin from Afghanistan. But like Iran, it has been assumed that much of the meth that is being consumed and smuggled from Pakistan is made in Pakistan or in Iran itself. India is of course another possibility in South Asia. With a prospering middle class, growing party culture and increasing transport links to Afghanistan and Iran it would seem a likely target. But where is the evidence? Across the Middle East, there are several countries that are at risk of becoming importers of Afghan meth. Iraq and Syria have increasingly been cited as experiencing a rapid uptake in methamphetamine use, but that too has typically been assessed as having been produced in-country. Saudi Arabia reportedly consumes vast amounts of captagon pills and amphetamines , some of which have been found to contain methamphetamine. The Gulf states are another possible market, but they have seized little methamphetamine. And while in the past the Kingdom of Bahrain has made significant seizures of methamphetamine, seizing just over 1 metric ton in , this was very much an anomaly and it was always assumed that the suppliers were not in Afghanistan. And what of Europe? Official records indicate methamphetamine consumption is concentrated in the Czech Republic and the Netherlands, and both have productive capacity of their own. Why would those trading meth using well established contacts and methods source their product from further afield and from plant-based production? And how would consumers react to any perceived change in quality? A review of what we do know about the market for methamphetamine in the region and Europe — which is admittedly rather limited — does lead us to the most challenging aspect of the rapid growth in the methamphetamine industry in Afghanistan. And that is, what is the need for the scale of the productive capacity that has developed there? After all, the relative ease by which precursors in most meth consuming nations can be obtained, and the rudimentary chemistry required, suggests it might be easier to produce methamphetamine closer to where it is ultimately consumed. Are there enough consumers out there to absorb what is being produced from oman in Afghanistan? Will the lower production costs of ephedra-based methamphetamine help penetrate new consumer markets, possibly aided by the well-trodden smuggling routes for heroin? Or is what is occurring in the mountains and deserts of Afghanistan a market anomaly that will be corrected, and in time oman will simply go back to being used as firewood, and no longer a source of revenue for drug traffickers, corrupt government officials and the insurgency in Afghanistan? Please read our comments policy before commenting. He has been conducting research on rural livelihoods and poppy cultivation in Afghanistan for 23 consecutive growing seasons. David has also worked for the Afghanistan Research and Evaluation Unit since The core team at OSDR have worked together since and with David Mansfield on a wide range of research projects since I have focused my attention on this for well over 26 years. Thank you.. That aside using North American markets as my crystal ball by using the plant material as a starting point the ephedrine,nor ephedrine, pseudo ephedrine,etc is chemical the same , however the actual product although chemically identical is shall we say predominantly excuse the pun its polar opposite. Shall we say its twin brother if one were good and the other were bad. So no its not what its cut with its just born weaker with no option to possible to clean or isolate its stronger brother. A lesson in stereochemistry would explain my explanation for anyone wanting to understand ephedrine and its isomers and everything else I just explained but again kudos excellent article. I would posit that the Opium transit points to Western markets have created their own drug markets, with ensuing interest in meth, which goes so well with heroin — and certainly some PDUs prefer an upper over a downer. Your email address will not be published. Notify me of follow-up comments by email. Notify me of new posts by email. Search for:. Blog Admin September 30th, From firewood to precursor In the past, oman had few economic benefits. Large Oman bushes in the mountains of Ghazni. Fresh, dried and threshed The oman harvest is not easy. The Oman crop being harvested in Ghor One of the distinct advantages of harvesting a crop with such high demand is that the traders come to you — a helpful feature for those living high up in the mountains unfamiliar with such developed markets. From crop to crystal The journey to the factories from the mountains in Taywara is arduous. Once the dried oman crop is unloaded in Abdul Wadood bazaar it is sold to the meth labs As time has passed lab owners have become more discerning customers of oman, and their cooks better at processing it. A downturn in the meth economy All of those involved in the meth economy say it is not what it was. A meth lab in Bakwa, Farah still functioning despite a downturn in both oman and meth prices and recent interdiction efforts Although there is a notable reduction in oman and sheesha prices from the previous year, business continues. How far afield does Afghan meth travel? About the author Blog Admin. Leave a Comment Cancel reply Your email address will not be published. Related Posts Presidential Election. Book Review Forum. John Collins. December 1st, 4. LSE Comment. We use cookies on this site to understand how you use our content, and to give you the best browsing experience. To accept cookies, click continue. To find out more about cookies and change your preferences, visit our Cookie Policy.

Oman buying MDMA pills