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INTRODUCTION

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The following are covered in this section:

  • Controlled Substances Act

  • Food, Drug, and Cosmetic Act

  • Poison Prevention and Packaging Act

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CONTROLLED SUBSTANCES ACT (CSA) SUMMARY

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I. Schedules of Controlled Substances

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A controlled substance is placed in its respective schedule based on whether it has a currently accepted medical use in treatment in the United States, compared to the product’s relative abuse potential and likelihood of causing dependence.1

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Note: States also have the authority to schedule drugs under state law, and may schedule a drug product more stringently. Be sure to check your state’s law to determine whether any products are classified differently under your state’s law.

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  1. Schedule I

    • Substances in this schedule have a high potential for abuse, and have 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.

    • Examples: marijuana, LSD, heroin.

  2. Schedule II

    • Substances in this schedule have a high potential for abuse, which may lead to severe psychological or physical dependence.

    • Examples: hydrocodone/acetaminophen, hydromorphone, methadone, amphetamine, methylphenidate.

  3. Schedule III

    • Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

    • Examples: acetaminophen with codeine, buprenorphine, ketamine, oral or injectable anabolic steroids.

  4. Schedule IV

    • Substances in this schedule have a low potential for abuse relative to substances in Schedule III.

    • Examples: primarily sedatives and hypnotics (including alprazolam, diazepam, midazolam, etc.), carisoprodol, phenobarbital.

  5. Schedule V

    • Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

    • These are generally used for antitussive, antidiarrheal, and analgesic purposes, and if available without a prescription are referred to as “exempt narcotics.”

    • Examples: preparations containing not more than 200 mg of codeine per 100 mL or per 100 g, diphenoxylate with atropine, cough and cold preparations containing codeine (Robitussin A-C, Phenergan VC, etc.).

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121 C.F.R. § 1308.11-1308.15

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II. Registration Requirements

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  1. New Pharmacy Registration2

    • Every pharmacy that dispenses a controlled substance must be registered with the DEA.

    • To register as a new pharmacy, a state license must be obtained and DEA Form 224 must be completed.

    • Manufacturers/wholesalers/importers/exporters/researchers register with DEA Form 225, and renew with 225a.

    • Hospital registrations are issued to the entire hospital as an “institutional practitioner.”

    • Separate registration is needed for each pharmacy owned or operated by the same entity.

    • Separate registration is needed for each category of activity engaged in by the pharmacy (see sub-paragraph “G,” below).

  2. Renewal of Pharmacy Registration

    • A pharmacy registration must be renewed every three years utilizing DEA Form 224a.

  3. Termination of Registration

    • A pharmacy that discontinues business activities either ...

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