Drug regulations

Australia
Therapeutic goods in Australia are regulated by the Therapeutic Goods Administration (TGA).[1] The availability of drugs and poisons is regulated by scheduling under individual state legislation, but is generally under the guidance of the national Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).
Under the SUSDP, medicinal agents generally belong to one of five categories:
Unscheduled/exempt
Schedule 2 (S2) - Pharmacy Medicines
Schedule 3 (S3) - Pharmacist Only Medicines
Schedule 4 (S4) - Prescription Only Medicines
Schedule 8 (S8) - Controlled Drugs
See also: Illicit drug use in Australia
[edit]Brazil
Therapeutic goods in Brazil are regulated by the Brazilian Health Ministry, through its Sanitary Surveillance Agency (equivalent to USA's FDA). There are 5 main categories:
Normal Medicines - Cough, cold and fever medicines, antiseptics, vitamins and others. Sold freely in pharmacies and some large supermarkets.
Red Stripe Medicines - These medicines are sold only with medical prescription. Antibiotics, Anti allergenics, Anti inflammatories, and other medicines. In Brazil, governmental control is loose on this type; it is not uncommon to buy this type of prescription medicine over the counter without a prescription.
Red Stripe Psychoactive Medicines - These medicines are sold only with a "Special Control" white medical prescription with carbon copy, which is valid for 30 days. The original must be retained by the pharmacist after the sale and the patient keeps the carbon copy. Drugs include anti-depressants, anti-convulsants, some sleep aids, anti-psychotics and other non-habit-inducing controlled medicines. Though some consider them habit inducing, anabolic steroids are also regulated under this category.
Black Stripe Medicines - These medicines are sold only with the "Blue B Form" medical prescription, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes sedatives (benzodiazepines), some anorexic inducers and other habit-inducing controlled medicines.
"Yellow A Form" prescription medicines - These medicines are sold only with the "Yellow A Form" medical prescription - the most tightly controlled, which is valid for 30 days and must be retained by the pharmacist after the sale. Includes amphetamines and other stimulants (such as methylphenidate), opioids (such as morphine and oxycodone) and other strong habit-forming controlled medicines.[2]
[edit]Canada
In Canada, regulation of therapeutic goods are governed by the Food and Drug Act and associated regulations. In addition, the Controlled Drugs and Substances Act requires additional regulatory requirements for controlled drugs and drug precursors.[3]
[edit]China
The regulation of drugs in China is governed by the State Food and Drug Administration.
[edit]Europe
[edit]United Kingdom
Medicines for Human Use in the United Kingdom are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The availability of drugs is regulated by classification by the MHRA as part of marketing authorisation of a product.
The United Kingdom has a three-tiered classification system:
General Sale List (GSL)
Pharmacy medicines (P)
Prescription Only Medicines (POM)
Within POM, certain agents with a high abuse/addiction liability are also separately scheduled under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001; and are commonly known as Controlled Drugs (CD).
[edit]Norway
Medicines in Norway are divided into five groups:
Class A Narcotics, sedative-hypnotics, and amphetamines in this class require a special prescription form:
morphine and its immediate family, heroin, desomorphine, nicomorphine;
codeine and its immediate family, dihydrocodeine, ethylmorphine, nicocodeine;
morphine relatives: hydromorphone and oxymorphone;
codeine relatives: hydrocodone and oxycodone;
synthetic opioids: pethidine, methadone, fentanyl, and levorphanol;
various sedative-hypnotics: temazepam, methaqualone, pentobarbital, and secobarbital;
various stimulants: amphetamines and methylphenidate;
flunitrazepam (moved from class B)
Class B Restricted substances which easily lead to addiction like:
co-codamol, diazepam, nitrazepam, and all other benzodiazepines (with the exception of temazepam and flunitrazepam), phentermine;
Class C - All prescription-only substances
Class F - Substances and package-sizes not requiring a prescription
Unclassifieds - Brands and packages not actively marketed in Norway
[edit]Iceland
Medicines in Iceland are regulated by the Icelandic Medicines Control Agency [1].
[edit]Switzerland
Medicines in Switzerland are regulated by SwissMedic.[4] The country is not part of the European Union, and is regarded by many as one of the easiest places to conduct clinical trials on new drug compounds.
There are 5 categories from A to E to cover different types of Delivery category:
A: Single delivery on medical prescription
B: Repeated delivery on medical prescription
C: Prescription free delivery after consultation of a specialist, restricted to pharmacy/chemist
D: Prescription free delivery after consultation of a specialist, restricted to pharmacy, chemist and drugstore
E: Prescription free delivery without consultation in all shops/stores
[edit]India
Medicines in India are regulated by CDSCO - Central Drugs Standard Control Organization Under Ministry of Health and Family Welfare. Headed by Directorate General of Health Services CDSCO regulates the Pharmaceutical Products through DCGI - Drugs Controller General of India at Chair.
Under Retail and Distribution:- Drugs classified under 5 heads
1. Schedule X drugs – Narcotics
2. Schedule H and L – Injectables, Antibiotics, Antibacterials
3. Schedule C and C1- Biological Products-example Serums and Vaccines

Under Manufacturing Practice
1. Schedule N
List of the equipment for the efficient running of manufacturing wing, Qualified personnel
2. Schedule M

what is medical drugs

In the United States, the Federal Food, Drug, and Cosmetic Act defines what requires a prescription. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, medical practitioners, and advanced practice nurses. It is generally required that an MD, DO, PA, OD, DPM, NMD, ND, DVM, DDS, or DMD, some Psychologists (see Medical Psychology), clinical pharmacists, Nurse Practitioners and other APRNs write the prescription; basic-level registered nurses, medical assistants, emergency medical technicians, most psychologists, and social workers as examples, do not have the authority to prescribe drugs.[1]
The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies.
The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration (FDA) is charged with implementing this law.
As a general rule, over-the-counter drugs (OTC) are used to treat conditions not necessarily requiring care from a health care professional and have been proven to meet higher safety standards for self-medication by patients. Often a lower strength of a drug will be approved for OTC use, while higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s but is still available by prescription in doses up to four times the OTC dose for use in cases of severe pain not adequately controlled by the lower, OTC strength.
Herbal preparations, amino acids, vitamins, minerals, and other food supplements are regulated by the FDA as dietary supplements. Because specific health claims cannot be made, the consumer must make informed decisions when purchasing such products. In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule FDA 21 CFR Part 111. In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.[2]
In the United States, the term "prescription drug" is most commonly used, but they are also called Rx-only drugs or legend drugs, after the Federal and State laws which mandate that all such drugs bear a "legend" prohibiting sale without a prescription; though more complex legends have been used, on most original drug packaging today the legend simply says "Rx only".
Also, pharmacies operated by membership clubs, such as Costco and Sam's Club, by law must allow non-members to use their pharmacy services and must charge the same prices as to members.[citation needed]
Physicians may legally prescribe drugs for uses other than those specified in the FDA approval; this is known as off-label use. Drug companies may not promote or market drugs for off-label uses.
Large U.S. retailers that operate pharmacies and pharmacy chains use inexpensive generic drugs as a way to attract customers into stores. Several chains, including Walmart, Dillons, Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw.[3]