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FEDERAL LAWS AND REGULATIONS FOR PHARMACIES, PHARMACISTS AND PRESCRIPTIONS

The Federal Controlled Substances Act (CSA) of 1970 is the basis for all practice-oriented drug law and regulations. It's important to note that this is a closed-loop system that goes from manufacturer through administration or dispensing to the patient. Each controlled substance dosage is carefully recorded and tightly controlled. A nightmare of any pharmacist is missing controlled substances or having incorrect counts.

The CSA was brought about to regulate the manufacturing, distribution, dispensing, and delivery of drugs that have a potential for physical and/or psychological abuse. CSA is regulated by the Drug Enforcement Agency (DEA) with a federal registration of all persons in the chain of manufacturing, distribution, and dispensing except the ultimate user: patients or their caregivers don't have their own DEA number to track. The DEA registration number must be renewed every 3 years and specific forms are used to renew registrations (i.e. DEA Form 225 is the form used for new applications for registration of new applicants and DEA Forms 224a, 225a, 363a, and 510a are used for renewal registrations). All records should be maintained for at least 4 years. However, federal facilities like veteran administration (VA) hospitals don't fall under the state laws of CSA as it is a federal level of practice. These potentially abusive drugs were termed "controlled substances" and broken down into five schedules. These medications have a "C" on their stock bottles.

The five schedules are based on medical use and potential for abuse and dependence as outlined below. Be sure to know what medications are listed in each of these schedules!

Note: Some states have specific rules such as medical marijuana which is becoming popular nationwide. Be sure to follow the more stringent law when answering questions on the MPJE unless they specify a focus on state.

C-I

Drugs which have a high potential for abuse have no currently accepted medical use (i.e., Heroin) in treatment in the United States, and there is little data on the accepted safety for use of the drug under medical supervision. These drugs may not be prescribed, administrated, or dispensed for medical use, but they may be ordered for research and investigational use. This controlled substance class can be ordered using DEA Form 222/CSOS. Examples: Marijuana, Heroin, LSD, Peyote, Salvia.

C-II

These medications have a high potential for abuse but also have an accepted medical use. It's important to know that no refills or transfers are allowed for this controlled substance class. Patients are allowed to have up to 3 individual 30-day prescriptions of a C-II totaling 90 days. So, if Sally brings in a prescription for OxyContin, she is allowed to make three fills with three separate prescriptions but will need to see her prescriber after the 90-day supply is dispensed to get additional prescriptions. ...

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