Online Pharmacies: What You Need to Know

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International Pharmacy Regulations


If you buy medication from a foreign country, then you want to know how the dispensing source is regulated and licensed by the appropriate governing authorities. While the FDA does not usually prevent Americans from importing medication for personal use, consumers must use good judgment in determining from which pharmacies and countries they feel most comfortable ordering medications. For this reason, PharmacyChecker.com verifies the licenses of pharmacies in different countries, and in some cases inspects pharmacies for quality standards.


A decade ago most non-U.S. pharmacies selling prescription drugs to Americans were Canadian. 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, led to an increasing number of countries entering the industry. Today, pharmacies in other countries, such as Australia, Barbados, India, Israel, Italy, Mauritius, 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 internationally for lower drug prices, below is an overview of the agencies and the laws that regulate drugs and pharmacies that participate in PharmacyChecker.com’s programs.


Generally, countries with the most advanced and safe systems for regulating pharmaceuticals possess the following:


  • 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
  • National laws and standards for labeling, storing, and distributing prescription drug products
  • 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
    • Require a doctor’s prescription for drugs that are determined to have potentially serious side-effects
    • Regularly inspects pharmacies
  • Drug manufacturing laws that require all approved products to be produced under Good Manufacturing Practices

Overview of Pharmaceutical Regulation: By Country


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 FDA. 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 authority, managed by a licensed pharmacist, and meet stringent standards for the storage and dispensing 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 were very similar.


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Australia


In Australia drugs are regulated by the Therapeutic Goods Administration, Australia's counterpart to the U.S. FDA. Australia uses very similar standards as the European Union (EU) for the regulation of prescription drugs.


As in Canada and the U.S., 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. the Guild’s 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 manufacturers, wholesalers, and other organizations responsible for the provision of health products.


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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. Among the requirements is that a licensed pharmacist is on the pharmacy premises and oversees the dispensing process. These international mail-order pharmacies operate in a free trade zone.


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 in Barbados can only import from licensed wholesale pharmacies based in countries with strong pharmaceutical regulations.


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.


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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, India’s counterpart to the U.S. FDA, 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 they are in the United States. Indian pharmacy members are inspected by PharmacyChecker.com to verify that they are meeting safe standards of mail-order pharmacy practice.


India has a very large and highly sophisticated pharmaceutical industry. In fact, a sizable portion of the world’s pharmaceutical active ingredients and finished products are manufactured in India. These ingredients and finished products are then exported to other countries such as the U.S. and the EU for the manufacture of final drug products or sale of finished products in local pharmacies. India is the world’s largest exporter of generic drugs.


Many drugs in India are manufactured in FDA-approved or inspected facilities. In fact, the U.S. FDA inspects more drug manufacturing plants in India than any other country outside the United States. However, the drug supply in India is not as strongly regulated as it is in the U.S. and some other high-income countries, such as Canada and the United Kingdom. Consequently, it has a higher rate of counterfeit and substandard medication. PharmacyChecker.com inspections and policies greatly minimize the risk that Indian pharmacies approved in the verification program would sell a counterfeit or substandard drug.


Click here for up to date information on Indian pharmacy and drug safety issues.


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Israel


The Pharmacology Department 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. To become a pharmacist in Israel, one must meet stringent education, training, and testing requirements.


Under its pharmaceutical regulations, drugs approved for sale in Israel must be manufactured using U.S. or EU standards for Good Manufacturing Practices. Additionally, drugs approved for use in Israel are generally already approved for use in the U.S. or EU. Israeli pharmaceutical companies are major suppliers of generic drug products to the United States.


Under Israeli law, drug labels must be in Hebrew and English.


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Mauritius


The Government of Mauritius permits qualified companies to operate international mail-order pharmacies in a free trade zone. Such pharmacies must employ licensed pharmacists to oversee the dispensing process, comply with all pharmacy regulations in Mauritius promulgated by the Ministry of Health and Quality of Life, such as the requirement that a prescription be produced for all dispensed items, and ensuring that effective sanitary and safety measures are implemented in the dispensing area.


While pharmacies operating in a Mauritius 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 strong pharmaceutical regulations.


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.


New Zealand


The drug supply of New Zealand is regulated by Medsafe, that country’s counterpart to the U.S. FDA. Medsafe determines which drugs are safe and effective for New Zealand’s citizens: 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 New Zealand’s professional pharmacist’s association. It provides education, training, and career development for pharmacists to achieve high standards of pharmacy practice. The Pharmacy Council is the national regulatory body for licensing pharmacist.


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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 EU. 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 U.S., 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 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, EU, 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 retail pharmacies.


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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 country, and PharmacyChecker has not permitted pharmacies from such areas to participate in its program. PharmacyChecker.com also conducts its own inspections of pharmacies in Turkey that participate in its Verification 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 U.S. 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.


Under the Pharmacists and Pharmacies Law, Turkey mandates 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.


Some pharmacies in Turkey are licensed as exporters and exported products may not be approved for sale in Turkey. PharmacyChecker.com verifies the licenses of pharmaceutical wholesalers that supply such pharmacies in Turkey.


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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. FDA and decides which drugs are safe and effective for sale with the UK. The EMEA is in an agency of the EU 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, including the UK.


On a national level, pharmacists and pharmacies are registered with and regulated by the General Pharmaceutical Council. Pharmacies must be operated by a licensed pharmacist, maintain safe storage conditions and a sanitary dispensing area. The Council issues an online seal for its registered pharmacies to place on their websites for those pharmacies that wish to do so.


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