Drug Regulations & Control

Controlled Substances Schedule/ Class I – HIGH potential for abuse and NO accepted medical use in the US. Schedule/ Class II – HIGH potential for abuse which may lead to physical or psychological dependence. Schedule/ Class III – Potential for abuse less than I and II; may lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids and codeine included in this class.

Schedule/ Class IV – low potential for abuse relative to class III Schedule/ Class IV – low potential for abuse relative to class III. Phenobarbital and other anesthetics are in this group. Schedule/ Class V – lowest potential for abuse. Compounds containing limited amounts of narcotics.

Schedule II drugs MUST be kept for 7 years Schedule II drugs MUST be kept for 7 years. All other records are only kept for 2 years. Schedule II drugs are kept in a locked, tamper- proof cabinet usually secured to the floor. Other schedule drugs can be kept on open shelves. All prescribers of controlled substances must be authorized by the DEA.

DEA Numbers Required by federal law Two letters followed by seven single digit numbers Ex: AB12344563 To verify # add 1st, 3rd and 5th digit to double the sum of the 2nd, 4th, and 6th digit. The last number of that total should equal the last # of the physician DEA #.

DEA Forms DEA 222 * most important – order form for Schedule I/II drugs DEA 224 – application for new registration DEA 224a - renewal DEA 224b – pharmacy chain renewal DEA 41- inventory drug surrendered DEA 106 – report of theft or loss of controlled substances DEA 363 – narcotic treatment program, application DEA 363a – narcotic treatment program, renewal DEA 510 – application for chemical registration

Recalls CLASS 1 Strong likelihood that the product will cause serious adverse effects or death. Class 2 May cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects. Class 3 Product is not likely to cause adverse effects. Recall process on page 55.

Provides a foundation for state laws. Federal law Provides a foundation for state laws. Specific laws enforced by FDA and DEA; also laws regulating treatment of patients.

State law Each state has a professional regulation or state board that is responsible for licensing ALL prescribers and dispensers. In many cases, state regulations are stricter than federal. Follow the stricter regulations. Each state has different regulations, YOU are responsible for knowing your own states regulations.

Professional Pharmacy Bodies ASHP, USP, TJC (JCAHO), and ASCP Legal Liability Compounding Regulations Ethics and Compliance