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  2. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    The 200 and 300 series are regulations pertaining to pharmaceuticals : 202-203 Drug advertising and marketing; 210 et seq. cGMPs for pharmaceuticals; 310 et seq. Requirements for new drugs; 328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New ...

  3. Regulation of therapeutic goods - Wikipedia

    en.wikipedia.org/wiki/Regulation_of_therapeutic...

    Limited OTC drug (Obat bebas terbatas), drugs available to the public only through pharmacy (apotek) or licensed drug stores. Marked by blue circle with black line. Prescription drug (Obat keras), prescription only medicine. Marked by red circle with letter "K" inside circle and black line.

  4. Prescription Drug Marketing Act - Wikipedia

    en.wikipedia.org/wiki/Prescription_Drug...

    The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.

  5. CFR - Code of Federal Regulations Title 21

    highline.huffingtonpost.com/miracleindustry/...

    report forms, drug samples, and labeling, including, if applicable, any Medication Guide required under part 208 of this chapter. Other applications will generally contain only some of those items, and information will be limited to that needed to support the particular submission.

  6. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the drug or give the drug to another person, such as a minor. Inserts for over-the-counter medications are also written plainly. [1] [2]

  7. Pharmaceutical marketing - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_marketing

    Marketing to health-care providers takes three main forms: activity by pharmaceutical sales representatives, provision of drug samples, and sponsoring continuing medical education (CME). [1] The use of gifts, including pens and coffee mugs embossed with pharmaceutical product names, has been prohibited by PHRMA ethics guidelines since 2008.

  8. List of Schedule III controlled substances (U.S.) - Wikipedia

    en.wikipedia.org/wiki/List_of_Schedule_III...

    The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently [1] accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

  9. List of Schedule I controlled substances (U.S.) - Wikipedia

    en.wikipedia.org/wiki/List_of_Schedule_I...

    The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1]