FEDERAL LAWLECTURE FOR

ASSIGNMENT 1 AND 2

TrueFalse

1True or FalseControlled substance act

consolidates many laws into 1

CSA

·The DEA is the lead federal law enforcement agency; responsible for fighting drug diversion. The Act was brought about to collect and conform lots of laws into one piece of legislation.

TrueFalse

EVERY PHARMACY THAT DISPENSES CS MUST BE REGISTERED WITH DEA2

True or False

Pharmacy requirements for dispensing CS

·Every pharmacy which dispenses any controlled substance must be registered with the DEA.·Any official of the Public Health Service or Bureau ofPrisons who is authorized to prescribe, dispense or administer,but not to procure or purchase, controlled substances in thecourse of his or her official duties, is not required to be registeredwith DEA. Such officials must specify their agency and serviceidentification number of the issuing official in lieu of a DEAregistration number on any prescriptions for controlledsubstances. The service identification number for a public HealthService employee is his/her Social Security Number.

TrueFalse

There are 2 ways to Dr can obtain permission to prescribe CS

3True or False

HOW TO PRESCRIBE CS.

· Authorized to prescribe controlled substances by the jurisdiction in which he/she is licensed to practice;

· Registered with DEA or exempted from registration (i.e., Public Health Service and Bureau of Prison physicians).

4 Controlled Substance Act is designed to do which of the following?

Ato improve the administration and regulation of the manufacture, distribution, and dispensing of CS

B to enforce the controlled substance act

Cto provide an “open system” for distribution

D both A and C

Multiple choice

WHAT IS THE CSA DESIGNED TO DO

·The provisions of the CSA are designed to improve the administration and regulation of the manufacture, import/export, distribution and dispensing of controlled substances by providing a"closed system" for distribution. Under this closed system, a controlled substance can be traced from the time it is manufactured to the time it is dispensed to the ultimate user. This system has proven effective in reducing the diversion of these substances from legitimate channels to the illicit market.

5Which of the following practitioners require a DEA number to prescribe, dispense, or administer controlled substances?A MILITARY

DR. B Bureau of prison personalC DR. DDS DVM

D Public Health Servants

Multiple choice

Who must register with dea to prescribed CS

·A prescription order for a controlled substance may be issued onlyby a physician, dentist, podiatrist, veterinarian, mid-levelpractitioner

Pharmacy DEA registration must be renewed every.....

1. 1 year2. 2 years3. 3 years4. 5 years

pharmacy RENEWAL

·Pharmacy registrations must be renewed every three years. The cost of the registration is annotated on the application form. The certificate of registration must be maintained at theregistered location and kept available for official inspection. If a person owns and operates more than one pharmacy, each place of business must be registered.

C-IIC-III

C-IV

C-V

C-I

Note question

·The substances in this schedule have a high abusepotential and no accepted medical use in the United States.This is the only schedule that includes drugs that are not availablefor prescribing, dispensing or administering·Substances in Schedule II have a high abuse potential withsevere psychological or physical dependence liability, have anaccepted medical use in the United States, and are available forpractitioners to prescribe, dispense and administer.

·The substances in this schedule have an abuse potentialwhich is less than those in Schedule II, but more than Schedule IVsubstances.·The substances in this schedule have an abuse potentialless than those listed in Schedule III and more than substances inSchedule V.

Practitioner’s Use of a Hospital’s DEARegistration Number

· An individual practitioner (e.g., intern, resident, staff physician, mid-level practitioner) who is an agent or employee of a hospital or other institution may, when acting in the usual course of business or employment, administer, dispense or prescribe controlled substances under the registration of the hospital or

other institution in which he or she is employed, provided that:

1. The dispensing, administering, or prescribing is in the usual course of professional practice;

2. The practitioner is authorized to do so by the state in which he or she is practicing;

3. The hospital or institution has verified that the practitioner is permitted to dispense, administer or prescribe controlled substances within the state;

4. The practitioner acts only within the scope of employment in the hospital or institution;

5. The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized (See example of a specific internal code number below);

7 LABEL REQUIREMENTS

List the seven requirements for prescription medication containers and labels.

1. pharmacy name and address2. serial number3. date of dispensing4. patient name5. physician name6. directions for use7. cautionary statements or labels

HARD COPY REQUIRMENTS

List the written requirements on a hard-copy prescription.1. Dated and signed on the date when issued.2. The prescription must include the patient’s name and address3. The Practitioner’s name, address, and registration number4. The prescription must also include the drug name, strength, dosage f orm, quantity, directions for use, and the number of refills

CAUTION STATEMENT REQUIRED

“Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

HOW LONG MUST RECORDS BE KEPT

Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, distributed, dispensed or otherwise disposedof. All records of controlled substances

must be maintained for two years.

INVENTORY

Initial Inventory· When issued a DEA registration, a registrant must take an

initial inventory, which is an actual physical count of all controlled substances in their possession. If there are no stocks of controlled

substances on hand, the registrant should make a record showing a zero inventory. There is no requirement to

submit a copy of the inventory to the DEA.

Biennial Inventory· Following the initial inventory, the registrant is required to

take a biennial inventory (every two years), which requires the same information as the initial inventory

FILING OPTIONS

Option 1 (Three separate files)• A file for Schedule II drugs dispensed,• A file for Schedule III, IV and V drugs dispensed, and• A file for prescription orders for all noncontrolled drugs

dispensed.

Option 2 (Two separate files)• A file for all Schedule II drugs dispensed, opening or close of

business).• A file for all other drugs dispensed (noncontrolled and those

inSchedule III, IV and V). If this method is used, a prescriptionfor a Schedule III, IV and V drug must be made readilyretrievable

Option 3 (Two separate files)• A file for all Schedule II-V controlled substances. If this

methodis used, a prescription for a Schedule III, IV and V drug mustbe made readily retrievable by use of a red "C" stamp not lessthan one inch high. 8• A file for prescription orders for all noncontrolled drugs

dispensed.

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