Information about internet pharmacy law
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In the News About Online and Mail-Order Pharmacies: What You Need to Know
Benefits and Risks Types of Online and Mail-Order Pharmacies
Controlled Substances and Online Pharmacies PharmacyChecker.com Verification Program
PharmacyChecker.com Seal U.S. Drug and Pharmacy Regulations
Foreign Online Pharmacies Counterfeit Medication
A Note on Intellectual Property Rights BENEFITS AND RISKS:
Using an online or mail-order pharmacy (referred to below as online pharmacy) can save you a great deal of money and provide other benefits. However, there are also potential risks. BENEFITS:
Lower prices — Lower drug prices in other countries, lower overhead costs compared to bricks and mortar pharmacies, and lower price mark-ups by discount and wholesale pharmacies often result in savings compared to local pharmacy prices. You can quickly shop around for the lowest prices online. Click here to compare prices across verified online pharmacies. Privacy/Anonymity — You may feel more comfortable purchasing or asking questions online (or by fax or phone) regarding certain medications. However, privacy can be compromised if an online pharmacy uses your information for unauthorized purposes so it is important that the online pharmacy has an appropriate privacy policy; this is one of the things that PharmacyChecker.com checks for you.
Convenience — If you find it physically difficult to make it to the pharmacy, live in a remote rural area, or have a very busy schedule, online and mail-order pharmacies enable you to avoid travel and can save you time. Many online pharmacies will also remind you when you can order a refill to help you maintain your regimen. Medical information — Some online pharmacies provide useful information about medications and diseases as well as links to medical resources such as universities, government agencies, and health associations.
RISKS: Some online pharmacies do not dispense drugs through licensed pharmacies. It is essential that you use pharmacies that are licensed. Licensed pharmacies require safe dispensing practices and the oversight of licensed pharmacies. Purchasing drugs from an unlicensed pharmacy greatly increases your chances of buying counterfeit and/or substandard products. PharmacyChecker.com verifies that a site is, or fills orders with, a licensed pharmacy.
Some online pharmacies do not adequately protect your personal and financial information. It's important for an online pharmacy to include a privacy policy, one that promises not to share your personal information with third parties. Online financial transactions should be secured by the online pharmacy through adequate use of encryption technology. PharmacyChecker.com verifies whether privacy is promised and transmittal of financial information is secured. Some online pharmacies do not give their address and/or telephone number. If in the course of purchasing drugs from an online pharmacy you have a problem, question, or complaint, then it becomes very important to contact the company using its telephone number or address. Also, studies have shown that online pharmacies that do not publish adequate contact information are more likely to sell counterfeit products. PharmacyChecker.com verifies contact information and provides it in the Profile of each online pharmacy listed on this site.
Additional fees are typically added to the drug price. There is almost always a shipping fee and there may also be a medical fee, order fees, and/or an account set up fee. PharmacyChecker.com shows you these fees and compares total costs. Compare drug prices at http://www.pharmacychecker.com/ListingAlpha.asp. Prices can change quickly. Online pharmacies are continually changing their prices. Lowball prices are common in order to attract new customers, but these prices don't always last. PharmacyChecker.com regularly updates all prices.
Some online pharmacies don't adequately safeguard your health. By failing to require a prescription, some online pharmacies might send you medication that could be dangerous to you. PharmacyChecker.com verifies that online pharmacies require a prescription. Some online pharmacies may sell medications that can be extremely dangerous, if not taken under medical supervision. In the U.S., these drugs are known as controlled substances, such as hydrocodone, valium, or xanax. You should never order from a website offering to sell you controlled substances without a prescription or to write you a prescription for them based on your responses to an online questionnaire. Other drugs, known as restricted distribution drugs, such as such as accutane, mifeprex or thalomidare, while not controlled substances, are also very dangerous if taken without the appropriate medical supervision. For a list of these drugs see: http://www.fda.gov/Drugs/ResourcesForYou/ucm077252.htm. See the section below on controlled substances for more information.
To help you stay clear of "rogue" websites, PharmacyChecker.com checks for you whether online pharmacies are licensed, offer security and privacy of your information, provide an address and phone number, require a valid prescription and your medical information. In addition, PharmacyChecker.com maintains a list of Rogue Pharmacy Websites. By no means a complete list, these sites are known to not follow safe online pharmacy practices.
TYPES OF ONLINE AND MAIL-ORDER PHARMACIES: Online pharmacies, also called Internet pharmacies, are businesses that sell and market prescription drugs and other pharmacy products over the Internet and send them to consumers by mail.
PharmacyChecker.com estimates that there are 300-400 U.S., Canadian and other legitimate online pharmacies that market and sell their products throughout the United States. These are licensed pharmacies and their affiliates that accept prescription orders online and require a valid prescription from the customer. Prescription Requirements
Online pharmacies fall into different categories based on their prescription requirements: Traditional (Rx based on in-person examination)
Remote Consultation (Rx based on an online or phone consultation) None (Rx not required to order prescription medication. These are "rogue" sites)
Traditional Online Pharmacies Most legitimate online pharmacies require you to provide your original prescription -- the one obtained from an in-person examination with your doctor. Prices at online pharmacies that have a traditional prescription requirement are often lower than at online pharmacies that offer or accept prescriptions based on remote consultations (as described below) or that require no prescription at all. Pharmacies in this category include major national chains, neighborhood pharmacies in the U.S. and Canada, and large mail-order prescription fulfillment centers. Most pharmacies with a traditional prescription requirement carry the full stock of prescription drugs you would find in your neighborhood pharmacy.
Remote Consultation Online Pharmacies Some consumers wish to purchase prescription drugs without having to visit their physicians to obtain a prescription. There are online pharmacies, generally known as online consultation pharmacies, remote consulting pharmacies, or prescribing pharmacies, that work with physicians who review a patient’s self-reported medical history and then write a prescription if deemed appropriate. Often this is done for medications referred to as "Lifestyle" drugs that are non-addictive and less likely to require physician monitoring.
As an advisory, the American Medical Association and the U.S. Food and Drug Administration have issued statements asserting that remote consultations are a substandard medical practice when there is no prior doctor-patient relationship, one established by an in-person physical exam. However, a Mayo Clinic study found that remote consultations done properly for erectile dysfunction are as safe or safer than traditional medical consultations (see http://www.mayoclinicproceedings.com/content/83/8/890.full?sid=a5819934-f4bc-4390-929f-9a9a2072a165). U.S. states have different laws on what constitutes a valid doctor-patient medical consultation. Many states do not prohibit remote medical consultations as a basis for prescribing while a handful of states do. Two states have passed laws or granted express permissions that are directly supportive of remote medical consultations. A 2009 state law in Hawaii makes it expressly legal for a doctor to prescribe non-controlled drugs based on a remote medical consultation, as long as the consultation is conducted in real-time, such as by phone or video conference. The State of Utah has granted express permission for certain companies to offer remote consultation for the prescription of a limited number of non-controlled medicines.
Except where expressly permitted by law, the PharmacyChecker Verification Program will not approve remote consultation online pharmacies. Federal law prohibits remote consultations as a basis for prescribing controlled substances. See more information on controlled substances below.
No-Prescription Required Mail-order and Online Pharmacies Some rogue websites will sell you prescription medication without requiring any prescription at all, which can be extremely dangerous. Other websites that offer to sell you drugs without a prescription pose as online pharmacies for the purpose of stealing your credit card information. Ordering from such sites is exceedingly risky to your health and could lead to unauthorized use of your credit card and/or identity theft. See our list of Rogue Online Pharmacies for more information.
CONTROLLED SUBSTANCES AND ONLINE PHARMACIES: USE EXTREME CAUTION Unlike regular prescription drugs, which are regulated by the U.S. Food and Drug Administration (FDA), most products with a high potential for addiction and abuse are regulated by the U.S. Drug Enforcement Agency (DEA) and called controlled substances. U.S. pharmacies that sell controlled substances must have a license to do so, which is issued by the DEA. For a list of controlled substances go to http://www.usdoj.gov/dea/pubs/scheduling.html .
Unfortunately, some U.S. and foreign “rogue pharmacies" sell controlled substances to consumers who don't have a prescription. Americans with a valid prescription may legally order controlled substances from a website that are dispensed from a licensed U.S. pharmacy. Reputable Canadian and other non-U.S. pharmacies will NOT ship controlled substances to Americans. The PharmacyChecker.com Verification Program does not accept online pharmacies that sell controlled substances filled by foreign pharmacies. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) regulates the practice of online pharmacy at the federal level as it relates to controlled substance by making it “unambiguous that it is a per se violation of the Controlled Substances Act for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least one in-person medical evaluation.” (Federal Register/Vol. 74 No. 64, April 6th, 2009, p. 15599).
The PharmacyChecker.com Verification Program requires, and verifies, that online pharmacies abide by the requirements of the Ryan Haight Act. While all websites that sell controlled substances are subject to the Ryan Haight Act’s ban on prescribing controlled substances solely based on a remote medical consultation, only those sites that sell products in the schedule II category, the most highly addictive drugs, must include specific disclosures on their websites and apply for a special modification of their DEA registrations. To learn more about the specific requirements see the following page: https://www.pharmacychecker.com/sealprogram/websitedisclosure.asp. Information on controlled substances: Drug Enforcement Agency (http://www.usdoj.gov/dea/index.htm).
Range of Medications Sold By Online Pharmacies Not all online pharmacies sell the broad range of prescription drugs that you would expect to find in your neighborhood pharmacy. The product range of online pharmacies typically falls into one of the following categories:
"Full" range of medication, including prescription and over-the-counter products, as well as testing supplies and other health and beauty products just as you would find in a large pharmacy. "Over 500 drugs" includes almost all prescription medication sold at your neighborhood pharmacy.
"Between 250-499 drugs" covering those medications representing the majority of prescription sales. "Popular" medications, the 10 to 50 top-selling prescription drugs.
"Lifestyle" medications, such as those used for sexual enhancement, hair growth, contraception, weight loss, herpes, and smoking cessation. "Specialized" medications for a single purpose, such as for pain, or specific medical conditions.
THE PHARMACYCHECKER.COM VERIFICATION PROGRAM PharmacyChecker.com verifies information about three types of entities that participate in online pharmacy: 1) Pharmacies (retail, wholesale, and veterinary), 2) Affiliate websites, and 3) Referral Sites. Pharmacies have a bricks and mortar presence (a walk-in pharmacy), in which the bricks and mortar pharmacy and the website are one and the same company, or operate under the same holding company. An Affiliate website does not have a bricks and mortar pharmacy presence but refers orders to a licensed pharmacy. An online pharmacy Referral site simply links to drug-selling websites on which the drug order is actually placed. Note that sometimes a pharmacy will provide the option to have your prescription filled by another licensed pharmacy in a different country so that you can take advantage of lower international prices, in which case they operate as both Pharmacy and Affiliate.
All online pharmacies must have specific qualifications for approval in the PharmacyChecker Verification Program and to publish the PharmacyChecker.com seal on their websites. PharmacyChecker.com verifies the following qualifications: Pharmacy license (with applicable pharmacy board or licensing authority)
DEA-issued license for controlled substances (for U.S. pharmacies only - non U.S. pharmacies are not permitted to ship controlled substances into the U.S.) Prescription is required (based on an in-person examination, with exceptions where expressly permitted by law)
Privacy policy (one that affirms a consumer's information will not be shared with third parties) Financial and personal information is secure (encryption required on web pages where financial and personal information is transmitted)
Contact information (mailing address and phone number) Additionally, to ensure compliance with the Verification Program prescription requirements, PharmacyChecker.com conducts periodic “mystery shopping,” by posing as a consumer attempting to purchase medication without a prescription. PharmacyChecker.com also works with pharmacy experts to inspect licensed pharmacies in certain foreign countries to be sure that they adhere to high standards of pharmacy practice.
The PharmacyChecker.com Seal PharmacyChecker.com advises consumers to look for the PharmacyChecker.com seal (clickable image below and at http://www.pharmacychecker.com/sealprogram/choose.asp) before ordering prescription medication from a website, especially if the company is not generally well known. Online pharmacies are only authorized to publish the seal if they have met the criteria mentioned above. Just as important, to make sure a seal is valid, consumers should check that it links to a page hosted on www.pharmacychecker.com and provides a profile of the site.
To safeguard the marketplace, Microsoft, and Yahoo! use the Verification Program to help them qualify online pharmacy advertisers for their search marketing programs. These programs may require additional qualifying criteria. For information on search engine requirements for online pharmacy advertisers use the following links:
Yahoo Search Marketing Microsoft adCenter PHARMACEUTICAL AND PHARMACY REGULATIONS
U.S. Drug and Pharmacy Regulations In the U.S., the Food and Drug Administration (FDA), a division of the U.S. Department of Health and Human Services, is responsible for the regulation and safety of America's drug supply. New drug reviews, post-market surveillance, and drug recalls are carried out by the FDA. Pharmacies and pharmacists are regulated and licensed by the states. Pharmacy regulations differ a little from state-to-state but all require the presence and management of licensed pharmacists, strict enforcement of safe dispensing practices and safe storage requirements. The regulation of controlled substances, drug products with stronger and addictive ingredients (discussed in detail above), is the responsibility of the Drug Enforcement Agency (DEA). Pharmacies must have a DEA-issued license to sell controlled substances.
The National Association of Boards of Pharmacy (NABP) (www.nabp.org), the umbrella trade group for state pharmacy boards, created the Verified Internet Pharmacy Practice Site (VIPPS) program in 1999 responding to public concerns about websites selling drugs without abiding by federal and state laws. As of October 2009, there were only 16 VIPPS-certified pharmacies: Approximately half of these were pharmacy benefit management companies that operate online pharmacies, which are only available to their members. Other VIPPS members are national chain pharmacies, larger U.S. online pharmacies, and one specialty online pharmacy. The NABP VIPPS program is not open to Canadian pharmacies that serve the American market. For people living in the U.S., the potential benefits of buying from a U.S. online pharmacy rather than a foreign online pharmacy often include:
Lower prices on generics — in fact generic prices at some U.S. online pharmacies are often half the Canadian price due to greater competition in the U.S. market, Acceptance of prescription drug insurance to purchase drugs,
Lower shipping charges, Easier recourse to legal action if you are wronged by the online pharmacy, and
Generally strong pharmaceutical and pharmacy safety regulations, although many other countries have similarly strong regulations. If you do not have insurance, or your insurance does not cover the drugs you need, U.S. online pharmacies are almost always more expensive than their foreign counterparts — except for generic drugs and "lifestyle" drugs, such as Viagra.
Click here for a list of online pharmacies verified by PharmacyChecker.com. FOREIGN ONLINE PHARMACIES: IMPORTS ARE GENERALLY PERMITTED BUT NOT TECHNICALLY LEGAL
Personal Drug Importation: Over the past decade, millions of Americans who do not have health insurance, adequate drug coverage, or any drug coverage, as well as those seeking critical medications that are not available domestically, have purchased medication from Canadian and other foreign online pharmacies. This process is known as personal drug importation. The U.S. government generally does not stop individuals from importing medication for their own use (up to a three-month supply of non-controlled drugs), however it is technically illegal. We know of no instance when the FDA has taken legal action against an individual for personal drug importation of a non-controlled substance. Despite the technical illegality, the FDA provides regulation for government officials in the form of personal importation guidelines (see the FDA Coverage of Personal Importations policy at http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm).
While it happens infrequently, less than one percent of international prescription orders are confiscated. In these cases you will usually be informed by the FDA that your drug order has been seized. There is a greater prevalence of drug import seizures from non-Canadian countries, especially from less developed countries If you are buying medication from a foreign country, you want to know that the dispensing source is regulated and licensed by the appropriate governing authority. For this reason, PharmacyChecker.com acts to verify the licenses of pharmacies in foreign countries. Just several years ago, most non-U.S. pharmacies selling prescription drugs to Americans were Canadian. Today, pharmacies in other countries, such as Australia, Barbados, Curacao, Fiji, India, Israel, Italy, New Zealand, Singapore, South Africa, Switzerland, Turkey, and the United Kingdom play a larger role in meeting this demand. To better educate our visitors, many of whom are looking to foreign pharmacies for lower drug prices, below is an overview of the agencies and the laws that regulate drugs and pharmacies in some foreign countries.
Multiple Countries: Different Pharmaceutical Regulatory Systems The growth in demand for lower cost prescription drugs among Americans, and the supply problems faced by Canadian international pharmacies, largely a product of restrictive selling practices of drug companies, has led to an increasing number of countries entering the industry. While the FDA usually does not prevent Americans from importing medication for personal use, consumers should use good judgment in determining from which countries they feel most comfortable ordering medications.
The information below might be useful in determining from which countries you are willing to purchase medication. Countries with the most advanced and safe systems for regulating pharmaceuticals possess the following: 1) An agency that approves drugs for the national market through a:
Review of scientific evidence from clinical trials. Post-market surveillance to monitor unforeseen effects of drug utilization.
2) National laws and standards for labeling of drug products and distribution. 3) A national system and/or state/provisional systems for regulating pharmacies that:
Require pharmacy practitioners to have a top-level education and rigorous training; Mandate safety requirements for the handling and dispensing of medications;
Requires a doctor’s prescription for drugs that are determined to have potentially serious side-effects. Regularly inspects pharmacies.
4) Drug manufacturing laws that require all approved products to be produced under Good Manufacturing Practices. Overview of Pharmaceutical Regulation: By Country
CANADA: Drug and Pharmacy Regulation in Canada Canada’s systems for regulating drug products are very similar to those in the United States. At the federal level, the Therapeutic Products Directorate - an agency of Health Canada that regulates Canada's drug supply - is Canada's counterpart to the U.S. Food and Drug Administration. All drug products sold in Canada must be approved by the Therapeutic Products Directorate. Pharmacies in Canada are regulated by the provinces; a similar system to the U.S. in which states regulate pharmacies. To operate a pharmacy in Canada, the premises must be licensed by the provincial pharmacy board, managed by a licensed pharmacist, and meet stringent standards for the storage and disbursement of medication.
A report written for the State of Illinois in 2003 found that Canadian pharmacies in Manitoba were as safe if not safer than those in Illinois, and that the U.S. and Canadian systems for ensuring safety and efficacy of drug products are comparable. Useful links
The National Association of Pharmacy Regulatory Authorities (NAPRA): www.napra.org Health Canada: www.health-canada.ca.
Drug Importation From Canada “Report On Feasibility Of Employees and Retirees Safely and Effectively Purchasing Drugs from Canadian Pharmacies.” State of Illinois, Department of Central Management Services. October 27, 2003. Online Pharmacy Regulation in Canada: In 2003, the National Association of Pharmacy Regulatory Authorities (NAPRA), Canada's counterpart to the NABP, introduced the VIPPS program but, as of October 12, 2009, there are no participating pharmacies.
Click here for a listing of online pharmacies currently verified by PharmacyChecker.com, including Canadian sites. PharmacyChecker.com has published several interesting reports on price differences between the U.S. and Canada. These are found at http://www.pharmacychecker.com/News.asp.
FOREIGN COUNTRIES OTHER THAN CANADA AUSTRALIA:
In Australia drugs are regulated by the Therapeutic Goods Administration, Australia's counterpart to the U.S. Food and Drugs Administration. Australia uses the same standards as the European Union for the regulation of prescription drug products. Like in Canada and the United States, pharmacies are registered at the state/province level, and pharmacists must be registered in the states in which they practice. The state boards are incorporated in a federation called the Pharmaceutical Society of Australia that guides and proposes policies and standards for the safe practice of pharmacy.
Over 80% of Australia’s pharmacies belong to an organization called the Pharmacy Guild of Australia. Its role is to support its pharmacy and pharmacist members on workplace issues and training. The Guild also negotiates on behalf of its members with the government and drug manufactures, wholesalers, and other organizations responsible for the provision of health products. Useful Links
Therapeutic Goods Administration, Department of Health and Aging: http://www.tga.gov.au The Pharmacy Guild of Australia: http://www.guild.org.au/
The Pharmaceutical Society of Australia: http://www.psa.org.au/ BARBADOS:
The Government of Barbados allows and licenses qualified companies to operate as international mail-order pharmacies. Such licensure can be granted to pharmacies that are inspected by the Barbados Drug Service, a division of the Barbados Ministry of Health, and meet all requirements of the Pharmacy and Drug Services Act. These international mail-order pharmacies operate in a free trade zone. Among the requirements is that a licensed pharmacist is on the pharmacy premises and oversees the dispensing process. While pharmacies operating in a Barbados free trade zone are subject to the same requirements of licensed pharmacies in the home jurisdiction, they import prescription products outside the national drug supply. For approval in the PharmacyChecker Verification Program, international mail-order pharmacies can only import from licensed wholesale pharmacies based in countries with acceptable pharmaceutical regulation standards.
Pharmacies in free trade zones must undergo a rigorous inspection by PharmacyChecker.com before approval in its Verification Program. Additionally, PharmacyChecker.com verifies the licenses of exporting wholesale pharmacies that supply these pharmacies. CURACAO:
The Government of Curacao permits qualified companies to operate international mail-order pharmacies in a free trade zone. Such pharmacies are under the regulation of the Inspectorate of Public Health, Inspector of Pharmaceutical Affairs, and must employ licensed pharmacists to oversee the dispensing process. While pharmacies operating in a free trade zone are subject to the same requirements of licensed pharmacies in the home jurisdiction, they import prescription products outside the national drug supply. For approval in the PharmacyChecker Verification Program, international mail-order pharmacies can only import from licensed wholesale pharmacies based in countries with acceptable pharmaceutical regulation standards.
Pharmacies in free trade zones must undergo a rigorous inspection by PharmacyChecker.com before approval in its Verification Program. Additionally, PharmacyChecker.com verifies the licenses of exporting wholesale pharmacies that supply these pharmacies. INDIA: The Central Drugs Standards Control Organization (CDSCO), a division of the Indian Ministry of Health and Family Welfare, is responsible for drug approval and regulation, as well as for the licensure of pharmacies in India. CDSCO is responsible for approving new drugs for the Indian market, post-market surveillance, and enforcement actions to protect the Indian drug supply.
Under the CDSCO, the Drugs Control Administration is responsible for regulating pharmacies. They do so through the State Drug Control Offices, also called Food and Drug Administration offices, which inspect and license pharmacies, and enforce the Pharmacy Act of 1940, which require pharmacies to meet rigorous safety standards. Pharmacies in India must comply with similar regulations as those in the U.S., such as having a licensed pharmacist on the premises during hours of operation, safe storage of drugs, particularly those with special requirements (such as insulin), and safeguarding of controlled substances. However, India's enforcement standards are generally lower than in the United States.
While in many respects economically disadvantaged compared to the U.S. and countries of the European Union, India has a very large and highly sophisticated pharmaceutical industry. In fact, a sizable portion of the world’s pharmaceutical active ingredients are manufactured in India. These ingredients are then exported to other countries such as the U.S. and the EU for the manufacture of final drug products. In addition, India exports finished medications for retail sale to the U.S. and many countries. The FDA has approved hundreds of Indian drug products that are sold in U.S. pharmacies. Many drugs in India are manufactured in FDA-approved or inspected facilities. In fact, the U.S. Food and Drug Administration inspects more drug manufacturing plants in India than any other country outside the U.S. However, the drug supply in India is not as strongly regulated as it is in the U.S. and some other economically developed countries, such as Canada and the United Kingdom. Consequently, it has a higher rate of counterfeit medication.
Useful Links Central Drugs Standards Control Organization: http://cdsco.nic.in/
Pharmacy Council of India: http://pci.nic.in/ ISRAEL:
The Pharmaceutical Division of the Israeli Ministry of Health regulates that country’s drug supply, pharmacists and pharmacies. Israel’s system for pharmaceutical regulation is strongly based on both U.S. and EU pharmaceutical regulations. Israeli regulations require that drugs approved for sale in that country must be manufactured using U.S. or EU standards for Good Manufacturing Practices (GMP) and USFDA or equivalent European Standards. Additionally, drugs approved for use in Israel are generally approved for use in the U.S. or EU. Israeli pharmaceutical companies are major suppliers of generic drug products to the United States.
Pharmacies are licensed by the Israeli Ministry of Health. Under Israeli law, drug labels must be in Hebrew and English. Useful Links
Pharmaceutical Administration, Israeli Ministry of Health: http://www.health.gov.il/english/PagesE/default.asp?maincat=10 ITALY:
As a full and founding member of the European Union, Italy is a highly developed county with strong pharmaceutical and pharmacy standards. The Italian drug regulatory authority, a division of the Ministry of health, parallels that of fellow EU-members requiring that drug product approvals are based on rigorous scientific evidence and clinical trials to show safety and efficacy. The European Medicines Evaluation Authority is an agency of the European Union charged with evaluating the safety of new products for members of the EU. Drugs that are approved by the EMEA can be sold throughout Italy and the rest of the EU. Unlike in the United States only pharmacists can own a pharmacy. Pharmacies are subject to similar regulations regarding prescription procurement, storage, and dispensing, as in the United States.
Useful Links Federfarma: https://www.federfarma.it/
Italian Ministry of Health: Azienda Sanitaria Locale. NEW ZEALAND:
The drug supply of New Zealand is regulated by Medsafe, that country’s counterpart to the U.S. Food and Drug Administration. Medsafe determines which drugs will be used by citizens of New Zealand: it administers the application process for new drugs and is charged with post-market surveillance. Under the Medicines Amendment Act 2003, Medsafe is also responsible for issuing pharmacy licenses. Pharmacies in New Zealand are held to similar standards of practice as in Canada, the United Kingdom, and the United States. The Pharmaceutical Society of New Zealand is the professional pharmacist’s association. It provides education, training, and career development of pharmacists to achieve high standards of pharmacy practice. The Pharmacy Council is the national regulatory body for licensing pharmacists.
Useful Links Medsafe: http://www.medsafe.govt.nz
Pharmaceutical Society of New Zealand: www.psnz.org.nz/ Pharmacy Council: http://www.pharmacycouncil.org.nz/index.asp
Pharmacy Guild of New Zealand: http://www.pgnz.org.nz/ SINGAPORE:
Singapore is among the most economically developed countries, one with exceedingly strong regulations in all industry sectors, on a par with the United States, the United Kingdom, and the countries that comprise the European Union. It has very high pharmacy and pharmaceutical regulatory standards. Singapore is recognized by the World Health Organization Collaborating Centers in the areas of Transfusion Medicine, Drug Quality Assurance and Food Contaminants Monitoring. Pharmacies in Singapore are licensed at the national level by the Health Sciences Authority (HSA), a division of the Ministry of Health. As in the United States, pharmacies must meet stringent standards before licensure is granted. Pharmacies must be under the management of a licensed pharmacist registered with the Singapore Pharmacy Council. Among other requirements, safe dispensing equipment and storage facilities, requisite professional reference materials, and an adequate system for record keeping are all checked for legal compliance before a pharmacy is licensed in Singapore.
The regulation of drug products in Singapore is the responsibility of the Therapeutics Products Division, which operates as part of the Health Sciences Authority. Only products licensed by the Health Products Regulation Group are approved for the market. The drug approval process takes nine months, unless the product is already approved in the United States, European Union, and Australia, in which case there is an expedited process. Some retail pharmacies in Singapore are also licensed to operate as exporters. However, the Therapeutics Products Division does not guarantee the safety of exported products and they may not be approved for sale in Singapore. PharmacyChecker.com verifies the licenses of exporting wholesale pharmacies that supply these pharmacies.
Useful Links Health Sciences Authority (Registration of Pharmacies): http://www.hsa.gov.sg/publish/hsaportal/en/healthproductsregulation/GMP/auditlicensingpharmacies/certificateofregistration.html
Singapore Pharmacy Council: http://www.spc.gov.sg/html/SPBHome.htm Therapeutics Products Division: http://www.hsa.gov.sg/publish/hsaportal/en/healthproductsregulation/westernmedicines.html
SOUTH AFRICA: The Medicines and Related Substances Control Act, 101 of 1965, mandated the establishment of the South African Medicines Control Council (MCC). The MCC is responsible for the registration and control of pharmaceuticals for the purpose of public safety. Members of the Council are appointed by the Minister of Health.
Like the FDA in the United States, the MCC decides which drugs are safe and effective based on scientific evidence, either that presented by an applicant (drug manufacturer), through testing or both. The Medicines and Related Substances Control Act stipulates the guidelines and procedures by which a drug is approved in South Africa, including the requirements for clinical trials, adverse drug reactions, and reporting to the MCC by pharmaceutical companies. The Pharmacy Act of 1974 set the requirements for establishing a pharmacy in South Africa, and mandated the responsibility of licensing pharmacies to the South African Pharmacy Council. As in the United States, pharmacy standards in South Africa require a licensed pharmacist to exercise control over acquisition and storage of medicine, chemical and hazardous substances, public access to medicines, and a pharmacy's cleanliness.
The South African Pharmacy Council is also mandated with fostering, through advocacy, education and career development programs, the highest standards of pharmacy practice throughout South Africa. Useful Links
Medicines Control Council: www.mccza.com South African Pharmacy Council: www.pharmcouncil.co.za
SWITZERLAND: The counterpart to the U.S. Food and Drug Administration in Switzerland is called Swiss Medic. All prescription drugs sold in the Swiss Market must first be approved as safe and effective by Swiss Medic, using a similarly rigorous review process to that used in the United States. Switzerland is also under the regulation of the European Medicine Agency (EMEA), and all products approved by EMEA are approved for the Swiss market.
Switzerland is comprised of regional government bodies called Cantons (like states in the U.S.). Cantons are responsible for licensing and regulating retail pharmacies in Switzerland. Pharmacies in Switzerland must be under the management of a licensed pharmacist who oversees the dispensing process. Useful Links
Swiss Medic: http://www.swissmedic.ch/ The European Medicines Agency: http://www.emea.eu.int/
TURKEY: According to the World Health Organization, Turkey's drug licensing standards closely resemble the countries of the European Union. However, unregistered generic products remain a problem in the rural and eastern region of the county, and PharmacyChecker has not permitted pharmacies from such areas to participate in its program.
As guided by The Law of Pharmaceutics and Medical Products, drugs sold in Turkey must be approved by a division of the Ministry of Health, called Drugs and Pharmacy General Management, which is Turkey's counterpart to the FDA. The process for drug approval is administered by the Advisory Commission For the Registration of Medicinal Products For Human Use, a Commission of the Ministry's Scientific Advisory Board. The Commission is comprised of pharmaceutical research experts, clinicians, a pharmaceutical technologist, a pharmacologist, and a Ministry of Health representative. Unlike in the United States, where most prescription drugs are generic, a large majority of drug products sold in Turkey are brand name, and most of those produced by well-known international manufacturers. In fact, with first class manufacturing facilities, Turkey has become a major player in the manufacture of drug products, and Turkey has the world's 15th largest pharmaceutical market.
Under the Pharmacists and Pharmacies Law, Turkey mandates, at the national level, that all pharmacies meet high standards of pharmacy practice, such as having a licensed pharmacist on the premises during hours of operation, safe storage of drugs, and a clean, sanitary area for dispensing. Useful Links
World Health Organization: Regional Office For Europe — Turkey UNITED KINGDOM:
Drug products sold in the UK are regulated by the Medical and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Evaluation Agency (EMEA). The MHRA is the United Kingdom’s counterpart to the U.S. Food and Drug Administration and decides which drugs are safe and effective for citizens of the UK. The EMEA is in an agency of the European Union charged with evaluating the safety of new products for members of the EU. Drugs that are approved by the EMEA can be sold throughout the EU. On a national level, pharmacists and pharmacies are registered with and regulated by the Royal Pharmaceutical Society of Great Britain (RPSGB). Pharmacies must be operated by a licensed pharmacist, maintain safe storage conditions and a sanitary dispensing area.
Useful Links Medical and Healthcare Products Regulatory Agency (MHRA): http://www.mca.gov.uk/
The European Medicines Agency: http://www.emea.eu.int/ Royal Pharmaceutical Society of Great Britain: http://www.rpsgb.org.uk/
COUNTERFEIT MEDICATION Counterfeit medication is a global problem and the risks that you can be hurt by them are greater if you are buying drugs through the Internet from developing countries and/or those with poor regulations. Counterfeit medicines include those with wrong ingredients, no active or insufficient active ingredients, dangerous ingredients, as well as those with the right ingredients but fake packaging.
The World Health Organization reports that 50% of drugs ordered online from websites that don’t publish a physical address are counterfeit. It is not clear on what study this statistic is based but its warning should be heeded. One of PharmacyChecker.com’s requirements is that a website publishes a verifiable mailing address and phone number. One article in Foreign Policy Magazine based on a recent research project suggests that the risks are minimal if you purchase from verified websites (see http://www.foreignpolicy.com/articles/2009/08/19/aprescriptionforsafety). For more detailed information on counterfeit medication see the following document published by the World Health Organization: http://www.who.int/medicines/services/counterfeit/en/.
A Note on Intellectual Property Rights Countries have different laws for protecting the intellectual property rights of drug companies. For example, the United States allows the sponsor of a new drug to have exclusive sales and marketing rights for that product for 20 years. After that time, other companies may manufacture, market, and sell a generic version of that drug. Other countries might only protect the patent of a new drug for 10, 5, or no years at all.
Some international online pharmacies sell generic versions of drugs that are still under patents in the U.S. and, therefore not available for sale in the U.S. As such, these products are viewed as unauthorized drugs by the U.S. Food and Drug Administration. For information from the U.S. Food and Drug Administration on patents see www.fda.gov/cder/ob/faqs.htm.
as internet pharmacies no prescription some after to for this not while we be under during aboutTo find out more about intellectual property rights go to the website of the World Intellectual Property Organization at www.wipo.gov. Home Compare Prices Online Pharmacy Ratings About Online Pharmacies En Español About Us In the News News Blog Rogue Pharmacies Join Free Newsletter Verification Program Other Services Affiliate Program l Help/Contact Us Privacy Policy Copyright 2010, PharmacyChecker.com LLC. All rights reserved. PharmacyChecker.com Disclaimer and Proprietary Rights
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