EMERGENCY OR TEMPORARY SCHEDULING

In 1984, the FCSA was amended by the Comprehensive Crime Control Act of 1984. This act included a provision that allows the administrator of the DEA to place a substance, on a temporary basis, into Schedule I when necessary to avoid an imminent hazard to the public safety.

This emergency scheduling authority permits the scheduling of a substance that is not currently controlled, is being abused, and is a risk to the public health while the formal rulemaking procedures described in the FCSA are being conducted. This emergency scheduling applies only to substances with no accepted medical use. A temporary scheduling order may be issued for 1 year with a possible extension of up to 6 months if formal scheduling procedures have been initiated. The proposal and

order are published in the Federal Register as are the proposals and orders for formal scheduling.

During this time period, the DEA is required, by law, to complete the traditional scheduling process in order to permanently keep the drug or substance in Schedule I of the FCSA. The traditional scheduling process involves the collection, by the DEA, of all information pertaining to the chemistry, pharmacology, toxicology, abuse, and trafficking of the drug or substance. This data will ultimately be used by the DEA and HHS to decide the permanent scheduling of the drug or substance.

CONTROLLED SUBSTANCE ANALOGUES

A new class of substances was created by the Anti-Drug Abuse Act of 1986. Controlled substance analogues are substances that are not controlled substances, but may be found in the illicit traffic. They are structurally or pharmacologically similar to Schedule I or II controlled substances. A controlled substance analogue has no legitimate medical use. A substance that meets the definition of a controlled substance analogue that is intended for human consumption is treated under the FCSA as if it were a controlled substance in Schedule I.

INTERNATIONAL TREATY OBLIGATIONS

United States treaty obligations may require that a drug or other substance be controlled under the FCSA, or rescheduled if existing controls are less stringent than those required by the treaty. The procedures for these scheduling actions are found in Section 201 (d) of the FCSA.

The United States is a party to the Single Convention on Narcotic Drugs of 1961, designed to establish effective control over international and domestic traffic in narcotics, coca leaf, cocaine, and cannabis. A second treaty, the Convention on Psychotropic Substances of 1971, which entered into force in 1976, is designed to establish comparable control over stimulants, depressants, and certain hallucinogens. Congress ratified this treaty in 1980.

REGULATIONS

LEARNING OBJECTIVES: Explain the registration, recordkeeping, distribution, and security of drugs according to the Federal Controlled Substances Act (FCSA).

The FCSA creates a closed system of distribution for those authorized to handle controlled substances. The cornerstone of this system is the registration of all those authorized by the DEA to handle controlled substances. All individuals and firms that are registered are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances. See table 7-2.

REGISTRATION

Any person who handles or intends to handle controlled substances must obtain a registration issued by the DEA. A unique number is assigned to each legitimate handler of controlled drugs-importer, exporter, manufacturer, wholesaler, hospital, pharmacy, physician, and researcher. This number must be made available to the supplier by the customer before the purchase of a controlled substance. Thus, the opportunity for unauthorized transactions is greatly diminished.

RECORDKEEPING

The FCSA requires that complete and accurate records be kept of all quantities of controlled substances manufactured, purchased, and sold. Each substance must be inventoried every 2 years. Some limited exceptions to the recordkeeping requirements may apply to certain categories of registrants.

From these records it is possible to trace the flow of any drug from the time it is first imported or manufactured through the wholesale level, to the pharmacy or hospital that dispensed it, and then to the actual patient who received the drug. The mere existence of this requirement is sufficient to discourage many forms of diversion. It actually serves large corporations as an internal check to uncover diversion, such as pilferage by employees.

There is one distinction between scheduled items for recordkeeping requirements. Records for Schedule I and II drugs must be kept separate from all other records of the handier; records for Schedule III, IV,

Table 7-2. Regulatory Requirements

and V substances must be kept in a "readily retrievable" form. The former method allows for more expeditious investigations involving the highly abusable substances in Schedules I and II.

DISTRIBUTION

The keeping of records is required for distribution of a controlled substance from one manufacturer to another, from manufacturer to wholesaler, and from wholesaler to dispenser. In the case of Schedule I and II drugs, the supplier must have a special order form from the customer. This order form (DEA Form 222) is issued by the DEA only to persons who are properly registered to handle Schedules I and II drugs. The form is preprinted with the name and address of the customer. The drugs must be shipped to this name and address. The use of this device is a special reinforcement of the registration requirement; it makes doubly certain that only authorized individuals may obtain Schedule I and II drugs. Another benefit of the form is the special monitoring it permits. The form is issued in triplicate: the customer must keep one copy for his or her own files; he or she forwards two copies to the supplier who, after filling the order, keeps a copy for his or her own records and forwards the third copy to the nearest DEA office.

For drugs in Schedules III, IV, and V, no order form is necessary. The supplier in each case, however, is under an obligation to verify the authenticity of his or her customer. The supplier is held fully accountable for any drugs that are shipped to a purchaser who does not have a valid registration.

Those registered as manufacturers and distributors in Schedule I, II, or III narcotics are also required to submit periodic reports to the DEA of their manufacturing and distribution transactions. They are also required to file annual inventories of the Schedule I, II, or III narcotic-controlled substances that they handle. This data is entered into a system called the Automated Reports and Consolidated Orders System (ARCOS). It enables the DEA to monitor the distribution of controlled substances throughout the country and to identify retail level registrants that receive unusual quantities of controlled substances.

Dispensing to Patients

The dispensing of a controlled substance is the delivery of the controlled substance to the ultimate user, who may be a patient or research subject. Special control mechanisms operate here as well. Schedule I drugs are those that have no currently accepted medical use in the United States; they may, therefore, be used in the United States only in research situations. They generally are supplied by only a limited number of firms to properly registered and qualified researchers. Controlled substances may be dispensed by a practitioner by direct administration, by prescription, or by dispensing from office supplies. Records must be maintained by the practitioner of all dispensing of controlled substances from office supplies and of certain administrations. The FCSA does not require the practitioner to maintain copies of prescriptions, but certain states require the use of multiple copy prescriptions for Schedule II and other specified controlled substances.

Prescription Drugs

The determination to place drugs on prescription is within the jurisdiction of FDA. Unlike other prescription drugs, however, controlled substances are subject to additional restrictions. Schedule II prescription orders must be written and signed by the practitioner; they may not be telephoned into the pharmacy except in an emergency. In addition, a prescription for a Schedule II drug may not be refilled; the patient must see the physician again in order to obtain more drugs. For Schedule III and IV drugs the prescription order may be either written or oral (that is, by telephone to the pharmacy). In addition, the patient may (if authorized by the doctor) have the prescription refilled on his or her own up to five times and at anytime within 6 months from the date of the initial dispensing.

Schedule V includes some prescription drugs and many over-the-counter narcotic preparations, including antitussives and antidiarrheals. Even here, however, the law imposes restrictions beyond those normally required for the over-the-counter sales; for example, the patient must be at least 18 years of age, must offer some form of identification, and have his or her name entered into a special log maintained by the pharmacist as part of a special record.

SECURITY

DEA registrants are required by regulation to maintain certain security for the storage and distribution of controlled substances. Manufacturers and distributors of Schedule I and II substances must store controlled substances in specially constructed vaults or highly rated safes and maintain electronic security for all stor7-10

Table 7-3.-Federal Trafficking Penalties

age areas. Lesser physical security requirements apply to retail level registrants such as hospitals and pharmacies.

All registrants are required to make every effort to make sure controlled substances in their possession are not diverted into the illicit market. This requires operational as well as physical security. For example, registrants are responsible for making sure controlled substances are distributed only to other registrants who are authorized to receive them, or to legitimate patients and consumers.

PENALTIES

LEARNING OBJECTIVES: Identify the federal trafficking penalties for each schedule of drugs and the various types of marijuana. Explain the penalties provided in terms of quantity and first and second offenses.

The FCSA provides penalties for unlawful manufacturing, distribution, and dispensing of controlled substances. The penalties are basically determined by the schedule of the drug or other substance, and sometimes are specified by drug name, as in the case of marijuana. As the statute has been amended since its initial passage in 1970, the penalties have been altered by Congress. The following tables are an overview of the penalties for trafficking or unlawful distribution of controlled substances. This is not inclusive of the penalties provided under the FCSA. See tables 7-3 and 7-4.