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#874271 - 04/12/09 01:09 PM
Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
   
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Administrator
GRAND Pooh-Bah
Registered: 11/18/01
Posts: 6370
Loc: DrugBuyers.Com
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Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 Please CLICK HERE to read There is a period of time where people are welcome to comment on the RHA and you should all take some time to let the people in "charge" know how you feel about it To help you find the area for comments I quote a post by Patient2all: Of course, deadiversion.usdoj.gov doesn't exactly make it easy to figure out where to post the comments. It's also unusual for the 60 day comment period to begin after the implementation of a law. Suggests this law was rushed out with little forethought.... ------ However to zero in on where we can make our actual comments, goto http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480944156 and click the link at the top that says: "Docket DEA-2009-0004" If this help guide does not clearly show that they are clearly talking about OCS's and referral services I do not know what does. They call them "criminal facilitators" Quoted are portions... see attachment for more... The people that started all this at the RH web had an area for comments too but when the posts where not to their liking they removed it... A. Reasons for the LegislationThe unlawful use of pharmaceutical controlled substances has reached alarming levels in the United States in recent years, causing a substantial detrimental effect on the public health and safety. According to the most recently published National Survey on drug Use and Health (2007),5 6.9 million Americans reported using psychotherapeutic drugs 6 nonmedically during the prior month.7 With specific regard to pain relievers, 5.2 million respondents reported abusing these drugs,8 which is an 18 percent increase from 2004.9 This study further indicates that, in the United States, the abuse of prescription drugs is second only to that of marijuana and is higher than the abuse of cocaine, heroin and hallucinogens combined.10 Among persons aged 12 and older who reported using illicit drugs for the first time in 2007, abuse of pain relievers was the most common category of first-time illicit drug use.11 The false sense of security that some associate with the abuse of these substances is also alarming. Many mistakenly believe that if a drug may be prescribed for medical use, abusing that drug cannot be as harmful as abusing more conventional ‘‘street’’ drugs, such as heroin or cocaine. According to the 2005 Partnership Attitude Tracking Study 12, 40 percent of teens surveyed believe that prescription medicines are ‘‘much safer’’ to use than illegal drugs. Furthermore, the same study concluded that 31 percent believe there is ‘‘nothing wrong’’ with using prescription medicines without a prescription ‘‘once in awhile.’’ 13 One of the main factors contributing to the nationwide increase in the diversion of pharmaceutical controlled substances has been the rise in the number of Internet sites that sell or facilitate the sale of these drugs for other than legitimate medical purposes. While in-person ‘‘prescription mills’’ (practitioners’ offices that readily supply drug seekers with prescriptions for controlled substances without establishing a legitimate medical basis for doing so) have always been, and remain, a significant source of diversion, the advent of rogue Web sites that cater to those who abuse pharmaceutical controlled substances has allowed the criminal operators of these sites to exploit the anonymity of the Internet to generate illicit sales of controlled substances (and/or prescriptions therefor) that far exceed those of any in-person prescription mill. This is particularly evident when examining the data relating to the sales of hydrocodone, which is the most widely abused pharmaceutical controlled substance in the United States. According to data registered distributors of controlled substances provided to DEA 14 in 2006, 34 pharmacies in the United States that were supplying rogue Internet sites dispensed a total of more than 98 million dosage units of hydrocodone. Hence, these pharmacies each dispensed an average of approximately 2.9 million dosage units of hydrocodone per pharmacy in a single year. By means of comparison, the average pharmacy in the United States dispenses approximately 88,000 dosage units of hydrocodone per year. Congress passed the Ryan Haight Act precisely because of ‘‘the increasing use of prescription controlled substances by adolescents and others for nonmedical purposes, which has been exacerbated by drug trafficking on the Internet.’’ 15 The person for whom the Act was named, Ryan Haight, was ‘‘a California high school honors student and athlete who died in 2001 from an overdose of controlled substances that he had purchased from a rogue online pharmacy.’’ 16 According to the Senate Report accompanying the legislation, ‘‘Ease of access to the Internet, combined with lack of medical supervision, has led to tragic consequences in the online purchase of prescription controlled substances.’’ 17 The Senate Report then cited a list of examples of persons in the United States who had died from overdoses of controlled substances obtained via the Internet.18 B. Common Methods Employed by Operators of Rogue Web Sites That Sell Pharmaceutical Controlled Substances The rogue Web sites that the Ryan Haight Act seeks to eliminate take on a variety of appearances and use a variety of methods. One common factor is that all these Web sites are marketed toward drug seekers who are willing to pay a premium to obtain pharmaceutical controlled substances without having a legitimate medical need for them. While the ‘‘business models’’ that the operators of these sites employ to evade detection by law enforcement and/or to create the facade of compliance with the law have evolved significantly over time, there tend to be three categories of participants in these schemes: the prescribing practitioner; the pharmacy that fills the prescriptions; and the criminal facilitator (a non-DEA registrant) who runs the operation.19 While it has always been illegal to dispense a controlled substance without a legitimate medical purpose, prior to the Act, a rogue operator could design a site that would make it clear to drugseekers that pharmaceutical controlled substances could be obtained through the site without a legitimate medical purpose. For example, a typical rogue site would display prominently on its homepage a list of the pharmaceutical controlled substances that it sold and prompt customers to click on their desired drugs. These Web sites could easily be found by using any of various Internet search engines and entering search terms such as ‘‘hydrocodone no prescription.’’ Unsolicited e-mails or other forms of online advertising and marketing often steered potential customers to these Web sites; the advertisements announced that controlled substances could be readily obtained through the Web site without an in-person medical evaluation and sometimes without even a prescription—thus insuring a drugseeking customer could obtain the controlled substance without a legitimate medical need. Thus, prior to passage of the Act, attracting customers was relatively easy for these rogue Web sites. However, to deliver the goods that the customers were seeking (pharmaceutical controlled substances and/or prescriptions for such), the operator of the rogue Web site usually had to enlist the services of two types of DEA registrants: a practitioner and pharmacy. Thus, the typical criminal facilitator had to recruit an unscrupulous practitioner willing to prescribe controlled substances without a legitimate medical evaluation obtained through a bona fide doctor-patient relationship. While the overwhelming majority of practitioners would want no part of this type of improper arrangement, criminal facilitators were able to find some unscrupulous practitioners willing to participate. Investigations have revealed that these facilitators often target practitioners who carry significant debt, such as those recently graduated from medical school, or those who have retired and are looking for some ‘‘extra income.’’ Regardless of the motivations of the participating practitioners, the facilitator would persuade them to enter into an agreement whereby they would agree to write prescriptions for controlled substances without adhering to the standard professional practices employed by practitioners when evaluating the medical condition of patients and determining the appropriate treatment in return for payment from the facilitator based on the number of prescriptions they would write. These arrangements operated in several ways. In some instances, the facilitator would arrange for a practitioner to issue prescriptions for controlled substances based solely on reviewing online questionnaires the customers submitted to the Web site. Other schemes involved facilitators requiring the customers of the Web site to fax some documentation that purported to be the customers’ ‘‘medical records’’ and then having an unscrupulous practitioner issue prescriptions for controlled substances based on a ‘‘review’’ of these faxed documents. A third type of scheme involved the facilitator having customers of the Web site call a telephone number staffed by employees of the site, answer a series of questions purporting to create a ‘‘medical history,’’ and then have unscrupulous practitioners write the prescriptions based on these answers. Whatever the methods employed, these rogue Web site operations were merely a sham, as every step in the process was designed to sell customers controlled substances and/or prescriptions for controlled substances without regard to actual medical need. Some criminal facilitators have been content to take in the profits associated with selling the prescriptions for controlled substances. (Some rogue Web sites charge customers a separate fee for arranging the issuance of prescriptions.) Others have sought to increase their profits by also having customers fill the prescriptions through a pharmacy affiliated with the Web site. To achieve the latter, the criminal facilitator needed to enter into an agreement with an unscrupulous pharmacy that was willing—for a fee—to fill prescriptions for controlled substances with essentially no questions asked and for as many prescriptions as the Web site could steer toward the pharmacy.20 In addition to paying the pharmacy for the cost of the drugs, the criminal facilitator would also typically pay the pharmacy an agreed upon amount that, in some instances, amounted to millions of dollars. Given the amount of money to be made from these arrangements, DEA has seen pharmacies close their doors completely to walk-in customers and convert their entire business to filling orders generated from rogue Web sites. In some instances, criminal facilitators have used multiple brick and mortar pharmacies to service their list of drugseeking customers. In other cases, a single pharmacy has supplied multiple rogue Web sites. These rogue Web sites generally provide the customer with a wide variety of quick and easy payment methods, such as cash-on-delivery, lines of credit, and credit ‘‘gift’’ cards. They also typically structure the various steps of the ordering process so as to link and shift the buyer to different Web sites, making it difficult for investigators to connect payments, products, and Web providers together. Rarely do such rogue Web sites contain any identifying information about where the online pharmacy is located or who owns or operates the Web site. On the contrary, these Web sites frequently fluctuate in name and number minute by minute. Finally, the typical rogue Web site fails to provide any information on how a patient may contact the prescribing practitioner or the pharmacist to consult with them about the drug(s) ordered, including drug interactions and adverse reactions. Recognizing that these rogue Web sites fuel the abuse of prescription controlled substances and thereby increase the number of resulting overdoses and other harmful consequences, Congress passed the Ryan Haight Act to prevent the Internet from being exploited to facilitate such unlawful drug activity The Act contains specific examples of conduct which would violate 21 U.S.C. 841(h)(1). These examples in the Act, however, are not an exclusive list of the types of conduct that constitute violations of 21 U.S.C. 841(h)(1). With this proviso made clear, 21 U.S.C. 841(h)(2) lists the following as examples of violations: (A) Delivering, distributing, or dispensing a controlled substance by means of the Internet by an online pharmacy that is not validly registered with a modification authorizing such activity as required by [21 U.S.C. 823(f)] (unless exempt from such registration); (B) Writing a prescription for a controlled substance for the purpose of delivery, distribution, or dispensation by means of the Internet in violation of [21 U.S.C. 829(e)]; (C) Serving as an agent, intermediary, or other entity that causes the Internet to be used to bring together a buyer and seller to engage in the dispensing of a controlled substance in a manner not authorized by [21 U.S.C. 823(f) or 829(e)]; (D) Offering to fill a prescription for a controlled substance based solely on a consumer’s completion of an online medical questionnaire; and (E) Making a material false, fictitious, or fraudulent statement or representation in a notification or declaration under [21 U.S.C. 831(d) or (e)]. As these examples are largely selfilluminating, and some have already been addressed in this preamble, only limited further amplification is provided here. Paragraph (C), in particular, reflects that the Act was intended not only to prohibit DEA registrants from using the Internet to facilitate the unlawful dispensing of controlled substances, but to also prohibit non-DEA registrants from doing so. Most notably, paragraph (C) is aimed squarely at the criminal facilitator whose ‘‘business plan’’ for operating a rogue online pharmacy is to recruit an unscrupulous practitioner to write prescriptions based on insufficient or nonexistent medical evaluations and/or an unscrupulous pharmacist to fill such prescriptions. The Act contains certain categories of conduct that do not result in the participants falling within the Act’s definition of an online pharmacy. Specifically, 21 U.S.C. 841(h)(3) states: (A) This subsection [21 U.S.C. 841(h)(1)] does not apply to: (i) The delivery, distribution, or dispensation of controlled substances by nonpractitioners to the extent authorized by their registration under [the CSA]; (ii) The placement on the Internet of material that merely advocates the use of a controlled substance or includes pricing information without attempting to propose or facilitate an actual transaction involving a controlled substance; or (iii) except as provided in subparagraph (B), any activity that is limited to— (I) the provision of a telecommunications service, or of an Internet access service or Internet information location tool (as those terms are defined in section 231 of the Communications Act of 1934) [47 U.S.C. 231]; or (II) the transmission, storage, retrieval, hosting, formatting, or translation (or any combination thereof) of a communication, without selection or alteration of the content of the communication, except that deletion of a particular communication or material made VerDate Nov<24>2008 18:18 Apr 03, 2009 Jkt 217001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\06APR2.SGM 06APR2 pwalker on PROD1PC71 with RULES2 Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations 15605 33 Under the CSIEA, the importation of controlled substances into the United States is prohibited except by persons registered with DEA to do so or persons exempted from such requirement. 21 U.S.C. 952, 957, 960. In accordance with the CSIEA, DEA has issued a regulation authorizing a person to import certain controlled substances for personal medical use, provided the person has the drugs in his possession upon entering the United States, makes the required declaration to the U.S. Customs and Border Protection, and otherwise complies fully with the requirements of the regulation. 21 CFR 1301.26; 69 FR 55343 (2004). Under no circumstances is it permissible under the CSIEA or the regulations for a person to have controlled substances shipped into the United States for personal medical use. 34 United States v. Katz, 445 F.3d 1023, 1031 (8th Cir. 2006), cert. denied, 127 S.Ct. 421 (2006). 35 United States v. Lawson, 682 F.2d 480, 482 (4th Cir. 1982) (citations omitted), cert. denied, 459 U.S. 991 (1982). by another person in a manner consistent with section 230(c) of the Communications Act of 1934 [47 U.S.C. 230(c)] shall not constitute such selection or alteration of the content of the communication. (B) The exceptions under subclauses (I) and (II) of subparagraph (A)(iii) shall not apply to a person acting in concert with a person who violates paragraph (1). Thus, paragraph (A)(i) allows DEAregistered nonpractitioners (such as manufacturers and distributors) to utilize the Internet in carrying out activities authorized by their DEA registrations (and otherwise in conformity with the CSA) without being subject to liability under 21 U.S.C. 841(h)(1). Paragraph (A)(ii) allows for Web sites that advocate the use of controlled substances or contain pricing information ‘‘without attempting to propose or facilitate an actual transaction involving a controlled substance.’’ Paragraph (A)(iii) exempts from application of 21 U.S.C. 841(h)(1) Internet service providers, Web hosting services, and certain other specified entities that do not alter content of Internet transmissions. However, it is crucial to bear in mind that the exception of paragraph (A)(iii) does not apply to ‘‘a person acting in concert with a person who violates [21 U.S.C. 841(h)(1)].’’ Thus, any person whose conduct would be sufficient to prove that he conspired to violate 21 U.S.C. 841(h)(1), or aided and abetted such violation, is not immune from prosecution under paragraph (A)(iii). The second new criminal offense added by the Act is 21 U.S.C. 843(c)(2)(A). This provision expressly prohibits using the Internet to advertise illegal transactions in controlled substances. Specifically, this provision states: It shall be unlawful for any person to knowingly or intentionally use the Internet, or cause the Internet to be used, to advertise the sale of, or to offer to sell, distribute, or dispense, a controlled substance where such sale, distribution, or dispensing is not authorized by [the CSA] or by the Controlled Substances Import and Export Act.
Attachments
ryanhaightactimplementation.pdf (317 downloads)Description: Implementation of the RHA
Edited by Administrator (05/09/09 09:12 AM)
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#874324 - 04/12/09 02:51 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: Administrator]
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GRAND Pooh-Bah
Registered: 07/20/05
Posts: 5324
Loc: Reality
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The RHA seems to say all OCS's are considered online pharmacies even if they say they are referral services. I have not noticed any OCS displaying the info the this law requires on their Webs. Is there any OCS rep here that can comment on this? I noticed this too A. Basically, ALL OCS will have to be licensed through the DEA to be considered legit is how I read it...
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"Smoking, drinking, never thinking of tomorrow, nonchalant..Is that all you really want? No, sophisticated lady..The Duke"
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#874356 - 04/12/09 04:49 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: tigersmom]
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GRAND Pooh-Bah
Registered: 01/08/07
Posts: 3315
Loc: The Boonies
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The RHA seems to say all OCS's are considered online pharmacies even if they say they are referral services. I have not noticed any OCS displaying the info the this law requires on their Webs. Is there any OCS rep here that can comment on this? I noticed this too A. Basically, ALL OCS will have to be licensed through the DEA to be considered legit is how I read it... So, does this mean that using an OCS to facilitate a F2F will be illegal come the 15th since they aren't licensed through the DEA? It seems to me that they will all just become a doctor referral service - and I don't believe that is illegal...
_________________________
The true triumph of reason is that it enables us to get along with those who do not possess it - Voltaire
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#874551 - 04/13/09 09:27 AM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: Browser6252]
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Administrator
GRAND Pooh-Bah
Registered: 11/18/01
Posts: 6370
Loc: DrugBuyers.Com
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Since their rep is registered here this question would be best answered by them. It looks like what they offer, referrals to doctors offering in-person consultations, is within the law and it does not look like they can be considered an online pharmacy But the law is so broad in the definition of online pharmacies that interpretation can make online pharmacies out of many sites... even a link to a referral service may make a site qualify as an online pharmacy Quote from page 5 of the attacked document: (51) The term ‘‘deliver, distribute, or dispense by means of the Internet’’ refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet. This definition is plainly broad in scope, encompassing any activity utilizing the Internet that causes or facilitates the delivery, distribution, or dispensing of a controlled substance. This definition is incorporated into the Act’s definition of an ‘‘online pharmacy’’: (52) The term ‘‘online pharmacy’’ * * * means [with certain exceptions discussed below] a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet. The definition of ‘‘online pharmacy’’ is also broad in scope. First, it includes not only a ‘‘person’’ 23 but also any other ‘‘entity’’ or ‘‘Internet site’’—‘‘whether in the United States or abroad’’—that otherwise meets the definition of an ‘‘online pharmacy.’’ Second, it also includes not only any such person, entity or Internet site ‘‘that knowingly or intentionally delivers, distributes, or dispenses * * * a controlled substance by means of the Internet,’’ but also any such one who ‘‘offers or attempts’’ to do so.
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#876034 - 04/15/09 09:01 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: Administrator]
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Administrator
GRAND Pooh-Bah
Registered: 11/18/01
Posts: 6370
Loc: DrugBuyers.Com
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News Release [print-friendly page] FOR IMMEDIATE RELEASE Contact: Garrison Courtney Number: 202-307-7977 April 13, 2008 New Rules Governing Internet Pharmacies Go Into Effect TODAY Regulations Implement Ryan Haight Act APR 13 -- (Washington, DC)- New Drug Enforcement Administration (DEA) regulations implementing the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 go into effect Monday, April 13. These regulations will help to prevent the illegal diversion of powerful medications that can cause harm to consumers for whom they were not intended, for the profit of those who are not licensed to handle them and who would exploit the uninformed. The Interim Final Rule was published in the Federal Register this week, and the public has 60 days from its publication to submit comments to the DEA. The Ryan Haight Act, named for an 18-year-old who died after overdosing on a prescription painkiller he obtained on the Internet from a medical doctor he never saw, was enacted on October 15, 2008, through the joint efforts of his mother, Francine Haight, and members of Congress, with the support of the DEA. “Now that this law has been put into force it will be harder for cyber-criminals to supply controlled substances over the Internet and easier for us to prosecute them,” said DEA Acting Administrator Michele M. Leonhart. “These regulations add important new provisions to prevent the illegal distribution of controlled substances through the Internet. Its implementation will increase Internet safety and help prevent tragedies like Ryan Haight’s death from happening again.” The statute amends the Controlled Substances Act (CSA) by adding several new provisions to prevent the illegal distribution of controlled substances by means of the Internet, including: New definitions, such as “online pharmacy” and “deliver, distribute, or dispense by means of the Internet”; A requirement of at least one face-to-face patient medical evaluation prior to issuance of a controlled substance prescription; Registration requirements for online pharmacies; Internet pharmacy website disclosure information requirements; and Prescription reporting requirements for online pharmacies. Consistent with the CSA itself, the Ryan Haight Act relates solely to controlled substances. Controlled substances are those psychoactive drugs and other substances – including narcotics, stimulants, depressants, hallucinogens, and anabolic steroids – that are placed in one of the five schedules of the CSA due to their potential for abuse and likelihood that they may cause psychological or physical dependence when abused. Controlled substances constitute only a small percentage of all pharmaceutical drugs. Approximately 10 percent of all drug prescriptions written in the United States are for controlled substances, with the remaining approximately 90 percent of prescriptions being written for non-controlled substances. The amendments to the CSA made by the Ryan Haight Act, as well as the regulations being issued here, do not apply to non-controlled substances. Unscrupulous or “rogue” Internet pharmacies exist to profit from the sale of controlled prescription medicines to buyers who have not seen a doctor and don’t have a prescription from a registered physician. The pharmacies lack quality assurance and accountability, and their products pose a danger to buyers. They pretend to be authentic by operating websites that advertise powerful drugs with the “approval” of a “doctor” working for the drug trafficking network. Prescription medications are powerful drugs that, while lifesaving under some circumstances, can be harmful or even lethal under others, and registered physicians and pharmacists exist to advise consumers on the difference. DEA maintains a hotline for reporting suspicious Internet pharmacies. Call 1-877-792-2873 or click on the “Report Suspicious Internet Pharmacies” icon on the home page of http://www.deadiversion.usdoj.gov. Like Haight, nearly one in five teenagers (19%) has used a prescription medication to get high, according to the 2008 Partnership Attitude Tracking Survey (PATS) conducted by the Partnership for a drug-Free America. The same survey found that two in five teens believe the fallacy that prescription medicines obtained without a prescription are “much safer” to use than illegal drugs. The 2008 Monitoring the Future survey sponsored by the National Institute on drug Abuse found that 7 of the top 10 drugs abused by high school seniors are prescription or over-the-counter medications. Prescription drugs are now as common as marijuana as the gateway to recreational drug use and abuse by teenagers. For more information clarifying these new regulations or for information on how to submit written or electronic comments about them within the 60-day comment period, go to http://www.deadiversion.usdoj.gov. For more information on Ryan Haight, go to http://www.familieschangingamerica.org/board-story-ryan-h.html. For general information about drugs (including prescription drugs), drug abuse and prevention, go to http://www.getsmartaboutdrugs.com.
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#877461 - 04/18/09 10:16 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: zack1]
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GRAND Pooh-Bah
Registered: 05/16/02
Posts: 3498
Loc: NY/NJ
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I'm a bit reluctant/nervous about bringing it to the pharmacy as I'm thinking they are focused on the new regs, and probably not willing to discuss the dates. A difficult spot, as I know I have legit need for the meds, but don't want to debate laws with whomever I submit it too, or be told I'm breaking the law. Not for a moment do I want to minimize the devastating impact this ill-crafted and ill-named law has had on Chronic Pain patients, but: I'm very inclined to think that the typical pharmacist and less so the typical poorly trained pharmacist tech has any clue about this "Ryan Haight Law". There was very little mainstream media mention of its actual implementation. Similarly, pharmacy niche journals hardly contain a mention of it. Even on the forum where Ryan Haight was a highly respected "guru" when it came to dangerous, scary drug concoctions, there is zero mention of the law. The top two discussions right now are why hasn't Obama fully legalized MJ yet and a "denial discussion" about a report that their "X" might not always be pure.... ------- It's mostly us speaking of the cruel impact that this act has had on our attempts at living a semi-normal life. Again, that is not meant to minimize the actual scope and ramifications we will feel as a result of this law. The last thing I'd want to do is lull any of us into a false sense of complacency. We're now easier than ever targets to possibly prosecute, given the vague, jumbled wording of this law. ------- Still, in my experience, pharmacists tend to be clueless about anything beyond the basics they might have learned back in pharmacy school. Just this year, 2 disturbing knowledge lapses happened that I recall of the top of my head. There were others too..... 1) A pharmacist who didn't have the hydrocodone formulation the doctor had prescribed in stock rationalized that she could substitute a higher hydrocodone dosage. Why? Because hydrocodone is only a Schedule 4 medication  2) Another recent time when I was prescribed 7.5/500, the pharmacist was suspicious. Why? There is no such thing as hydrocodone 7.5/500. It needed to be verified as to how a physician would be so ignorant in putting down this "fake" dosage. The less than subtle implication was that the Rx itself was a fake ("I can't fill this, there is a problem with the Rx and I can't discuss it with you".) As the doctor wasn't reachable for a few days, I brought in a printout from pharmer.org to "prove" 7.5/500 existed. Of course, I could have easily "faked" the printout too, but that never occurred to the pharmacist  For that matter, it was on the shelf, in the PDR and no doubt could have been found on ------ Guess my point is while you must take care and be vigilant, don't assume your typical pharmacist at a chain outlet is "all knowing" and on top of every change in the law that comes down the pike, especially when it's at the national level. Don't go by me because I live in a less repressive state than some and I'm a bit more daring. However, were it me, I would get that Direct Script while the getting might still be good. Good luck, patient2all
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I'll be back...
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#878489 - 04/21/09 09:48 AM
New Rules Implement Ryan Haight Act
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Pooh-Bah
Registered: 08/12/05
Posts: 1142
Loc: SoMeWhEreOuThErE
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New drug Enforcement Administration (DEA) regulations implementing the Ryan Haight Act went into effect on April 13th. The Interim Final Rule was published in the Federal Register this week, and the public has 60 days from its publication to submit comments to the DEA. The Ryan Haight Act was named for an 18-year-old who died after overdosing on a prescription painkiller he obtained on the Internet from a medical doctor he never saw. After his death, Haight's story became a rallying point for relatives of others who had died from prescription drug overdoses to encourage the passage of the legislation that bears his name. Like Haight, nearly one in five teenagers has used a prescription medication to get high, according to the 2008 Partnership Attitude Tracking Survey (PATS) conducted by the Partnership for a drug-Free America. The same survey found that two in five teens believe the fallacy that prescription medicines obtained without a prescription are "much safer" to use than illegal drugs. The 2008 Monitoring the Future survey sponsored by the National Institute on drug Abuse found that 7 of the top 10 drugs abused by high school seniors are prescription or over-the-counter medications. Prescription drugs are now as common as marijuana as the gateway to recreational drug use and abuse by teenagers. Unscrupulous or "rogue" Internet pharmacies exist to profit from the sale of controlled prescription medicines to buyers who have not seen a doctor and don't have a prescription from a registered physician. The pharmacies lack quality assurance and accountability, and their products pose a danger to buyers. They pretend to be authentic by operating websites that advertise powerful drugs with the "approval" of a "doctor" working for the drug trafficking network. Prescription medications are powerful drugs that, while lifesaving under some circumstances, can be harmful or even lethal under others, and registered physicians and pharmacists exist to advise consumers on the difference. DEA maintains a hotline for reporting suspicious Internet pharmacies. "Now that this law has been put into force it will be harder for cyber-criminals to supply controlled substances over the Internet and easier for us to prosecute them," said DEA Acting Administrator Michele M. Leonhart. "These regulations add important new provisions to prevent the illegal distribution of controlled substances through the Internet. Its implementation will increase Internet safety and help prevent tragedies like Ryan Haight's death from happening again." The statute amends the Controlled Substances Act (CSA) by adding several new provisions to prevent the illegal distribution of controlled substances by means of the Internet. The Rules would require at least one face-to-face medical evaluation before a patient could receive a prescription for a controlled substance over the Internet. The new Rules also place tougher restrictions on online pharmacies. The Rules create new definitions of what classifies as an online pharmacy and what it means to deliver, distribute or dispense meds by means of the Internet. Rather than try to block all online pharmaceutical sales, the Rules called for by the Ryan Haight Act put online pharmaceutical sales on an equal regulatory footing with sales made through a brick-and-mortar facility. The Rules require an endorsement of an existing registration to allow existing pharmacies to sell controlled substances online. This means law enforcement will be able to carefully scrutinize all applications for such registration and be able to easily separate legitimate and illegitimate Internet operations. The Rules also set prescription reporting requirements for online pharmacies. Consistent with the CSA itself, the Ryan Haight Act relates solely to controlled substances. Controlled substances are those psychoactive drugs and other substances - including narcotics, stimulants, depressants, hallucinogens, and anabolic steroids -- that are placed in one of the five schedules of the CSA due to their potential for abuse and likelihood that they may cause psychological or physical dependence when abused. Controlled substances constitute only a small percentage of all pharmaceutical drugs. Approximately 10 percent of all drug prescriptions written in the United States are for controlled substances, with the remaining approximately 90 percent of prescriptions being written for non-controlled substances. The amendments to the CSA made by the Ryan Haight Act, as well as the regulations being issued here, do not apply to non-controlled substances.
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"Everyone has a photographic memory ....some just don't have any film."
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#878491 - 04/21/09 09:51 AM
New Rules Governing Internet Pharmacies
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Pooh-Bah
Registered: 08/12/05
Posts: 1142
Loc: SoMeWhEreOuThErE
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APR 13 -- (Washington, DC)- New drug Enforcement Administration (DEA) regulations implementing the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 go into effect Monday, April 13. These regulations will help to prevent the illegal diversion of powerful controlled substances by means of the Internet. Such medications can cause harm to consumers for whom they were not intended. The Interim Final Rule was published in the Federal Register this week, and the public has 60 days from its publication date to submit comments to the DEA. The Ryan Haight Act, named for an 18-year-old who died after overdosing on a prescription painkiller he obtained on the Internet from a medical doctor he never saw, was enacted on October 15, 2008 through the joint efforts of his mother, Francine Haight, and members of Congress, with the support of the DEA. “Now that this law has been put into force it will be harder for cyber-criminals to ply controlled substances over the Internet and easier for us to prosecute them,” said DEA Acting Administrator Michele M. Leonhart. “These regulations add important new provisions to prevent the illegal distribution of controlled substances through the Internet. Its implementation will increase Internet safety and help prevent tragedies like Ryan Haight’s death from happening again.” The statute amends the Controlled Substances Act (CSA) by adding several new provisions to prevent the illegal distribution of controlled substances by means of the Internet, including: New definitions, such as “online pharmacy” and “deliver, distribute, or dispense by means of the Internet”; A requirement of at least one face-to-face patient medical evaluation prior to issuance of a controlled substance prescription; Registration requirements for online pharmacies; Internet pharmacy website disclosure information requirements; and Prescription reporting requirements for online pharmacies. Consistent with the CSA itself, the Ryan Haight Act relates solely to controlled substances, specifically, those psychoactive drugs and other substances–including narcotics, stimulants, depressants, hallucinogens, and anabolic steroids–that are placed in one of the five schedules of the CSA due to their potential for abuse and likelihood that they may cause psychological or physical dependence when abused. Controlled substances constitute approximately 10 percent of all drug prescriptions written in the United States. The amendments to the CSA made by the Ryan Haight Act, as well as the regulations being issued here, do not apply to non-controlled substances. Consumers are advised that some websites operating on the Internet are legal, and others are not. Many of the legitimate Internet pharmacies have voluntarily sought certification as “Verified Internet Pharmacy Practice Sites” from the National Association of Boards of Pharmacy. However, unscrupulous or “rogue” Internet pharmacies exist only to profit from the sale of controlled prescription medicines to buyers who do not have a legitimate medical need for the medications. These rogue sites lack quality assurance and accountability, and their products pose a distinct danger to buyers. They pretend to be authentic by operating legitimate-looking websites that advertise powerful drugs with the approval of a doctor, but such doctors are employees of the drug trafficking organization. Because prescription medications are powerful drugs that have legitimate uses but can also be harmful or even lethal, DEA maintains a hotline for reporting suspicious Internet pharmacies. Call 1-877-792-2873 or click on the “Report Suspicious Internet Pharmacies” icon on the home page of http://www.deadiversion.usdoj.gov. Like Ryan Haight, nearly one in five teenagers has used a prescription medication to get high, according to the 2006 Partnership Attitude Tracking Study (PATS) conducted by the Partnership for a drug-Free America. The same survey found that two in five teens believe the fallacy that prescription medicines obtained without a prescription are “much safer” to use than illegal drugs. The 2007 Monitoring the Future survey sponsored by the National Institute on drug Abuse found that 7 of the top 11 drugs abused by high school seniors are either prescription or over-the-counter medications. Unfortunately, prescription drugs are now the drug of choice for a large percentage of new initiates among teenagers, even surpassing marijuana. For more information clarifying these new regulations, or for information on how to submit written or electronic comments about them within the 60-day comment period, go to http://www.deadiversion.usdoj.gov. For more information on Ryan Haight, go to http://www.familieschangingamerica.org/board-story-ryan-h.html. For general information about drugs (including prescription drugs), drug abuse, and prevention, go to http://www.getsmartaboutdrugs.com.
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"Everyone has a photographic memory ....some just don't have any film."
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#878554 - 04/21/09 12:32 PM
Re: New Rules Implement Ryan Haight Act
[Re: cuddles17981]
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GRAND Pooh-Bah
Registered: 05/16/02
Posts: 3498
Loc: NY/NJ
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This is such a victory? Then how come this draconian amendment to the CSA, crafted after a reckless young adult took his ultimate trip seems to be of no importance to his peers? The message board where Ryan Haight was known as a " a guru, a master at mixing the drugs he bought online, a deft chronicler of his own trips " has had zero concern about this new law and its impact on their "experimentation"? There is not even a mention or a discussion of the law among these surviving or next generation "ravers". Right now that forum's members are vigoursly disputing a report that claims the "X" they are buying is less than "99 & 44/100% pure." Vying for second place on Ryan Haight's favorite forum is a discussion wondering why it's taking so long for Obama to legalize MJ. These are your children and/or stupid young adults. Precisely those the law was designed to "protect". -------- On this forum we mostly see adults, very often older adults wondering how they'll maintain some continuity of needed medical treatment for Chronic Pain in an opiophobic national climate. Sadly, the fear of this taint even extends to the medical community whose very oath calls upon their membership to alleviate suffering. -------- Sadly, given the current political climate, the crowd at Ryan Haight's favorite and still unmolested forum have a greater shot of seeing their "weed" legalized before many members here see relief from unrelenting pain through legitimate and totally legal medication. MJ is simply considered "hip" and acceptable in so many circles nowadays. Even many of these young folks' parents retain fond memories of their bongs. Now, pain medication of any sort is tainted with the ugly "hillbilly heroin" brush by the media and any politician looking for an "easy issue" to back. Heaven forbid the "hillbilly heroin" should move from the trailer parks to comfortable upper middle class bedroom suburbs. -------- Go back some decades and the same fears heavily criminalized MJ lest "reefer madness" make its way from city slums to comfortable, upper middle class communities. The "evil weed" would destroy the social fabric of tidy neighborhoods with harrowing results. Why, the same fears were generally accepted for "race music" and hip-thrusting dancing at one time too. -------- Now, the MJ "menace" is a harder sell given that even our most recent Presidents were forced to acknowledge partaking liberally. In fact, they even had to conced that they went one step beyond to the more pernicious "white powders" as we've learned. So we needed a new "demon drug" and medications, some in use for decades, suddenly became "drugs". What is especially angering about this press release is that there is zero mention of patients who suffer daily, from the moment they awaken until they try to catch some elusive sleep at night. Admittedly, they would have been an "inconvenient truth" to acknowledge. It's not as easy as "going to see the Doctor" as so many have found out. Even the services that wish to offer the now requisite face-to-face consultations are hard pressed to find Physicians willing to take up the task of treating Chronic Pain patients. It's astounding that the bureaucrat who crafted this into the CSA, "Dr. Leonhart", who holds only a B.S. in Criminal Justice, can exert such power over the practice of medicine and its subsequent impact on the lives of patients. Sadly, patient2all
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I'll be back...
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#878596 - 04/21/09 01:40 PM
Re: New Rules Implement Ryan Haight Act
[Re: tem33]
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GRAND Pooh-Bah
Registered: 07/20/05
Posts: 5324
Loc: Reality
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sigh...I know that LE reads this forum, so please understand "prying eyes" that our voice is every bit as important as Francine Haight's. The average age of a DBer is mid-40's we are tax payers, and most have families to support. We are only seeking relief. I am sorry that some teenagers have died from using legal (and illegal) drugs, but kids have died from alcohol abuse, playing sports, and even, in a few cases, from drinking too much water. Such tragedies happen, and I know this from personal experience. But To throw the baby out with the bath-water is NO solution, and the issue of chronic, untreated pain will only get worse as the boomers retire, so be prepared.
I can only hope that one day America will wake up and see what a mistake the DEA is making, and how the billions of dollars spent on "The War on Drugs" has done nothing but demonize pain patients, and gutted the 4th Amendment.
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"Smoking, drinking, never thinking of tomorrow, nonchalant..Is that all you really want? No, sophisticated lady..The Duke"
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#880244 - 04/24/09 07:41 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: patient2all]
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Stranger
Registered: 06/26/08
Posts: 24
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Thank you very much patient2all/tem33 for your advice; I went ahead and had my direct script filled, and while I was very nervous, it went smoothly. But what I really want to thank you for is the much needed reminder that what I was doing was not wrong. I need medication for my medical issues, and I am not a criminal for needing these meds. My primary docs (GI, internist), while extremely capable and helpful, do not see the pain relief as a primary issue, and I'm a bit shy to press the issue, which is my fault. So I utilized telemedicine for this area of symptom relief. It seems that I will have to work on my reluctance to discuss this issue with my doctors, as now a valuable source of treatment is gone. But thank you so much for your help, advice and encouragement; without it, I would not have gone forward to fill my prescription, and these nice spring days would have been much different. Very uncomfortable, and probably useless in the area of functioning well and getting things done. I hope I can return the favor someday.
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#881903 - 04/29/09 02:29 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: stevo1]
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Board Addict
Registered: 12/17/05
Posts: 306
Loc: The Great Valley
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Ok, So I have a question. If you order something such as, Tramadol, Soma, etc..., how do the delivery people know if it is scheduled or not? Yes, I know they know it comes from a pharmacy, but so do my natural supplements, which my doctor told me to order off the internet, because they are cheaper than GNC. So, I`m just wondering, if you were to receive something other than hydro, etc, how do they know if it is a controlled substance? And by the way, yes I do have to sing for by B vitamins.
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Where you treasure is, there your heart will be also.
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#881907 - 04/29/09 02:48 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: Littlefoot]
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GRAND Pooh-Bah
Registered: 08/08/06
Posts: 2557
Loc: Top of The World!
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Ok, So I have a question. If you order something such as, tramadol, soma, etc..., how do the delivery people know if it is scheduled or not? Yes, I know they know it comes from a pharmacy, but so do my natural supplements, which my doctor told me to order off the internet, because they are cheaper than GNC. So, I`m just wondering, if you were to receive something other than hydro, etc, how do they know if it is a controlled substance? And by the way, yes I do have to sing for by B vitamins. I don't think they do know what is in the box or bag/ envelope
_________________________
I Need to Stare into my Avatar and Relax!
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#882311 - 04/30/09 02:50 PM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: stevo1]
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Member
Registered: 04/16/08
Posts: 182
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Unless you are getting a delivery every day from a Pharmacy ...I really don't think The Delivery service Cares! The Problem is if you are getting Controlled meds from a Pharmacy and did not have a F2F ...When the Pharm or the Doc gets Popped(and they will ...Sooner or Later) your Info will be in the Hands of the DEA....And the RHA has put specific Punishments/ Jail time and Fines on the Doc... The Pharm... The Receiver...And anyone else that helped you get your Meds! Like an Online Referral Service!! Or Possibly even a Discussion Board! Thanks for this information. Since DB.com used to be a forum about how to use telemedicine to find a doctor for pain management (among other conditions), I think a lot of us are interested in the specific penalties built into the RHA for receivers. I cannot find that information in the Act, and I have read it. Can you please link to the specific receiver penalties you are referencing? THANKS!!!!!
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#885102 - 05/08/09 08:51 PM
Re: New Rules Governing Internet Pharmacies
[Re: cuddles17981]
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GRAND Pooh-Bah
Registered: 05/16/02
Posts: 3498
Loc: NY/NJ
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Thank you, Cuddles. Of course, deadiversion.usdoj.gov doesn't exactly make it easy to figure out where to post the comments. It's also unusual for the 60 day comment period to begin after the implementation of a law. Suggests this law was rushed out with little forethought.... ------ However to zero in on where we can make our actual comments, goto http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=0900006480944156 and click the link at the top that says: "Docket DEA-2009-0004" I'm not that stupid, but it took me some time to figure this out. Now I will work on what I hope to be a powerful comment. We should all do the same! Come on, we have a big voice! It may not count in the end, but we've got to try. The promise of telemedicine mustn't die because of the ancient foolhardiness of a "raver" from a well-to-do family. That bunch will not feel any effects from this law -- they've always got their connections. It's the poor, underserved and truly ill folks who I see suffering... My only suggestion would be to not malign the memory of the young adult who this law was inappropriately named after. Let's stick to describing the devastating effects this law has had on our own individual quality of life. It is not true that anyone suffering Chronic Pain or anxiety disorders will find treatment in their local area. I've met far more charlatans in local Pain Management facilities than I ever found in those few quality OCS's that I used over the years. One reason "distance prescribing" found such a market among suffering Chronic Pain patients is because of the very real shortage of local Doctors willing to even talk to anyone who complain of Chronic Pain. Rightfully or wrongly, far too many Doctors shun us for real or imagined liability concerns. Instead, a few brave Doctors, few and far between had the guts to show compassion to the millions of us suffering out there in quiet desperation. Contrary to popular belief, the best OCS Doctors hardly made a fortune in their work. Yes, there were 45 second conslts by "physician's assistants", but there were also OCS Doctors who spent 45+ minutes consulting at some of the services. I know for a fact that those Doctors were not buying multiple yachts with their relatively meager consult fees. The two OCS Doctors that I dealt with over the years stated respectively, "I truly feel for those suffering in pain" and "I'm pretty good at discerning abusers even over the phone. i believe I'm right 99% of the time. If I let one abuser get over on me, I've still helped 99 people who were truly in need. That's a chance I'm willing to take." The latter Doctor I quoted has now decided to devoting all his time to treating the most neglected "street people" instead of continuing with F2F. How dare he!  Before he used to only spend evenings trying to bring the most downtrodden homeless people into the health care system. The first Doctor I cited is a 9/11 First Responder among possessing other esteemed credentials. Both Doctors had impeccable credentials and weren't trying to pay of gambling debts or anything like that. They truly believed in the promise of Telemedicine. Still, the bad ones ruined it for all -- as many have noted, the "baby was thrown out with the bathwater". It would be good for Admin to make the comment link more prominent on our site. Like many members here, I don't always get time to work my way through all the posts -- especially those that are further down in the forum list. ------- Telemedicine had promise and outside of this venue, we scarcely heard a word about it. Regulation was the answer. However, that was too unpopular a viewpoint for politicians to "risk" stating. patient2all
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I'll be back...
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#893959 - 06/08/09 11:29 AM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: Administrator]
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GRAND Pooh-Bah
Registered: 05/16/02
Posts: 3498
Loc: NY/NJ
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I'm ashamed of myself.  Somehow I got it in my head that the comment period for Docket DEA-2009-0004 ran until 6/13/09 or 6/15/09. It was 6/5/09 I missed it. I owed it to my wife to finish working on an expansive website that would bring in money -- something I haven't been too good at lately. So I rationalized to myself that as soon as I had that site up and running, a concise, but powerful comment would be posted. I also wanted to update a site that would direct people to the regulations.gov site so more of us could be heard. Skrewed up. Feel like the public perception will continue to hold that us " drug customers" went scurrying underground and had no real point to make. Would it have made a difference? We'll never know. We know we're the Chronic Pain Community but how many others do? ------ Right now the media is speaking to people in the "BDSM Community" about David Carridine's death and how it could have been avoided through "safe practice". I won't judge the BDSM folks, but really! They chose that life and get to live it freely and unencumbered. We didn't ask for any of what befell us. So BDSM is a bonafide "community" and reporting of their lifestyle now must follow the politically correct journalistic manner of style and we're still just "druggies" in too many eyes. Anybody got some "Hillbilly Heroin"?  ------------------ I'm worst at what I do best. Sorry! patient2all
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I'll be back...
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#919240 - 08/18/09 05:27 AM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: patient2all]
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Stranger
Registered: 07/24/09
Posts: 16
Loc: Cali
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i read the Wall Street Journal every day and i only remember hearing about this proposed legislation in the fall of 2008, nothing since except for what i just read in this thread tonight. the law being on the books is one thing, and i have to say i knew it would happen sooner or later - somebody orders stuff online and dies accidentally. the family has no where to go but use their anger and disgust to try and make it harder for this to happen again. all well and good. but if some kid is smart enough, they will find a way to get what they want, somehow. it remains to be seen how much effort is devoted to enforcement of the law. does this mean any controlled substance, that being schedule 2, schedule 3, schedule 4 and schedule 5 is off limits? i know that Schedule 1 drugs are things like Ecstasy, heroin, cocaine, LSD, and maybe marijuana in some states that don't have medical pot statutes (street drugs have no medical value, even for research purposes). i was hoping to purchase Cymbalta for my depression but now i don't know...i am pretty sure it's a schedule 4 antidepressant. i know diversion is a problem, but i would never condone it. i just feel terrible for folks with chronic pain, migraines, and the like who have used up all their options and can only afford canadian or other int'l pharmacies.
_________________________
"transition transmission...oh my TVC-15, oh oh, TVC-15"...david bowie, station to station LP
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#921973 - 08/26/09 07:54 AM
Re: Implementation and explanation of the Ryan Haight Act as per the DOJ and DEA
[Re: sf_280Hwy]
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Threadhead
Registered: 01/08/03
Posts: 919
Loc: Lost in my own mind
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[quote=sf_280Hwy]i read the Wall Street Journal every day and i only remember hearing about this proposed legislation in the fall of 2008, nothing since except for what i just read in this thread tonight. the law being on the books is one thing, and i have to say i knew it would happen sooner or later - somebody orders stuff online and dies accidentally. the family has no where to go but use their anger and disgust to try and make it harder for this to happen again. all well and good. but if some kid is smart enough, they will find a way to get what they want, somehow. it remains to be seen how much effort is devoted to enforcement of the law. does this mean any controlled substance, that being schedule 2, schedule 3, schedule 4 and schedule 5 is off limits? i know that Schedule 1 drugs are things like Ecstasy, heroin, cocaine, LSD, and maybe marijuana in some states that don't have medical pot statutes (street drugs have no medical value, even for research purposes). i was hoping to purchase Cymbalta for my depression but now i don't know...i am pretty sure it's a schedule 4 antidepressant. i know diversion is a problem, but i would never condone it. i just feel terrible for folks with chronic pain, migraines, and the like who have used up all their options and can only afford canadian or other int'l pharmacies. [/quote
Actually, cocaine is not a schedule I, it is a schedule to II. Pharmaceutical cocaine is a green liquid that is used for tracheotomy patients to control the bleeding around the trach site as it is a potent vasoconstrictor. It is used primary in neonatal units in the hospital. Also, Cymbalta is not scheduled.
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