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Text C

Certain drugs have a potential for abuse that leads to physical or psychological dependence. Therefore, these drugs have been placed into schedules (schedules I, II, III, IV, V) and they are referred to as controlled substances.

Schedule I drugs may not be kept in a pharmacy nor dispensed pursuant to prescription. The drug is placed in schedule I (marked as C1 or C–1) if:

a) the drug has a high potential for abuse;

b) there is a lack of accepted safety for its use under medical supervision;

c) the drug or other substance has no currently accepted medical use in the country.

All controlled substances in schedules II-V are the substances with a lower potential for abuse.

All pharmacies and hospitals must conduct an initial inventory of all controlled substances in schedules II, III, IV and V. Initial inventory must be taken on the date the pharmacy starts business and begins dispensing controlled substances. If the pharmacy has no controlled substances on hand this fact must be recorded at its initial inventory.

Then, biennial inventory must be taken at least every 2 years from the date of the initial inventory.

Because all records for schedule II controlled substances must be maintained separately from other records, schedule II inventories must be maintained separately from other controlled inventories.

All inventory records must contain the date the inventory is taken, the name of each finished form of the substances (dosage form and strength), and the number of units or volume of each finished form in each commercial container (e. g. 100 tablet bottle). For opened commercial containers inventory must be taken as follows. For schedule II controlled substances, an exact count or measure must be taken. For schedules III, IV and V controlled substances, an estimated count or measure may be taken.

Schedule II controlled substances must be obtained from a supplier (wholesaler or manufacturer) by using DEA Form 222. The federal Pharmacy Law does not require the use of any special form to obtain substances in schedules III-IV. Each registrant must, however, maintain a complete and accurate receipt for each such substance. The record must be maintained at either the registered location of the pharmacy or hospital, or at a central location. For central records, an invoice or packing slip will suffice as a record of receipt.

Schedule II controlled substance prescription must be written with ink or indelible pencil or typewritten except in cases of oral emergency schedule II prescriptions. Schedule III-V controlled substance prescriptions may be orally ordered by the practitioner.

Controlled substances that are not prescription (or legend) drugs may be dispensed to a patient at retail without a prescription. These drugs do not have on the manufacturer’s label the federal statement: “Caution. Federal law prohibits dispensing without a prescription”. The dispensing must be made only by a licensed pharmacist. Not more than 8 ounces of any substance containing opium, 4 ounces of any other controlled substance, 48 dosage units of any substance containing opium, or 24 dosage units of any other controlled substance may be dispensed to the same purchaser in any 48-hour period, and the purchaser must be at least 18 years old.