Schedule V Controlled Substances

Drug abuse and dependence Pregabalin is a schedule V controlled substance. Pregabalin is not known to be active at receptor sites associated with drugs of abuse. 

Schedule V controlled substance, the client should not take more than eight in a 24-hour period. 

The pharmacist must ensure the medical necessity or the need for the product since there is no medical supervision for Schedule V controlled substances. 

Medications under the control of the US Drug Enforcement Agency (Schedules I-V controlled substances) are indicated by the symbol (C). Most medications are uncontrolled" and do not require a DEA prescriber number on the prescription. The following is a general description for the schedules of DEA-controlled substances ... 

There are established five schedules of controlled substances, to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules established by this section shall be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970, and shall be updated and republished on an annual basis thereafter. 

Schedule I and II controlled substances can be ordered only by a DEA registrant on the official DEA Form 222. Schedule III-V controlled substances are ordered through the normal ordering process for noncontrolled substances. No special forms are necessary for ordering Schedule III-V controlled substances. The registrant (pharmacy) must keep a record on the receipt (i.e., invoice... 

The transfer of Schedule III-V controlled substances must be documented in writing including the drug name, dosage form, strength, quantity, and date transferred. The document must include the names, addresses, and DEA registration numbers of the parties involved in the transfer of the controlled substances. 

The diversion and abuse potential associated with controlled substances warrants extensive record keeping involving every aspect of the controlled substances, from manufacturing to acquisition to dispensing to disposal/destruction. Purchasers are required to keep complete and accurate records for each controlled substance manufactured, purchased, received, distributed, dispensed, or otherwise disposed of for 2 years. All records must be available to the DEA for inspection and copying. All records and inventories of Schedule II controlled substances must be maintained separately from all other records of the registrant. All records and inventories of Schedule III-V controlled substances must be maintained either separately from all other records or in such a form that the information is readily retrievable from the ordinary business records at the time of DEA inspection. 

One file for all Schedule II-V controlled substances. If this method is used, a prescription for a Schedule II-V controlled substance must be made readily retrievable by use of a red C stamp not less than 1 in. high. If a pharmacy has an electronic record keeping system for prescriptions which permits identification by prescription number and retrieval of original documents by the prescriber s name, patient s name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red C is waived. 

Computers have made record storage much more manageable. An alternative to the three options listed above is to store records in a computer system. This is valid only for Schedules III-V controlled substances. Schedule II controlled substances must be stored separately. 

All Schednle II controlled snbstances mnst be connted. No estimation of Schedule II controlled substances is permissible. Inventory of Schedule III-V controlled substances may be estimated unless the container is opened and holds a quantity of more than 1000 dosage units. 

Prescriptions for Schedule III, IV, or V controlled substances may be written, oral, or faxed. Refills may be authorized by the practitioner provided they are indicated on the face of the prescription. A Schedule III, IV, or V controlled substance prescription may be refilled up to a maximum of five times within a 6-month period of time after the date of issue. The key is the date of issue not the date of filling. The 6-month time period runs from the date the prescription was issued not the date that the pharmacy fills the prescription. After five refills have been exhausted or the 6-month timeframe has been expired, the patient must obtain a new prescription. 

A pharmacist must record the following information on the back of a prescription when a pharmacist refills a Schedule III, IV, or V controlled substance prescription ... 

Fax prescriptions for Schedules III, IV, or V controlled substances are permissible and the fax is treated as the original prescription. 

Provided state allows, Schedule III, IV, or V controlled substance refill prescriptions may be transferred between pharmacies on a onetime basis. For those pharmacies that electronically share a real time online database (i.e., chain pharmacies), the pharmacy may transfer up to the maximum number of refills allowed by the practitioner on the prescription. The requirements necessary for the transfer are as follows ... 

There are still some states that permit the sale of Schedule II, III, IV, and V controlled substances over the counter. Only those controlled substances that are not a prescription item under the Federal Food, Drug and Cosmetic Act maybe dispensed without a prescription at retail provided that ... 

A pharmacist may receive a controlled substance prescription for Schedule III, IV, or V as a written prescription a facsimile transmitted by the practitioner or an oral prescription. If the prescription is an oral prescription the pharmacist must immediately reduce the prescription to writing ensming that the prescription contains all the necessary information required by the DEA and state law. At the printing of this book, the electronic transmission of controlled substance prescriptions is not considered valid. However, a prescription received via tbe Internet could be treated as an oral prescription. The pharmacist would be required to contact tbe practitioner and obtain tbe information from the practitioner including all the required information. The practitioner has 7 days to deliver a written follow-up prescription to the pharmacy. For oral Schedule III, IV, and V controlled substance prescriptions, the pharmacy is not responsible for notifying the DEA if a written follow-up prescription within the 7-day requirement is not received. The pharmacy does have an obligation to make a notation on the back of the oral prescription that it did not receive the written follow up within the 7-day period of time. 

What form must be used when transferring Schedule III-V controlled substances ... 

A. One file for all Schedule II controlled substances, one file for Schedule III-V controlled substances, and one file for all non-controlled drug products dispense. 

Schedule III, IV, and V controlled substance prescriptions may be transmitted to the pharmacy by which of the following means ... 

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