LECTURE FOR ASSIGNMENT 1 AND 2 FEDERAL LAW LECTURE FOR ASSIGNMENT 1 AND 2

1 Controlled substance act consolidates many laws into 1 True or False

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.

EVERY PHARMACY THAT DISPENSES CS MUST BE REGISTERED WITH DEA 2 True or False True 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 of Prisons who is authorized to prescribe, dispense or administer, but not to procure or purchase, controlled substances in the course of his or her official duties, is not required to be registered with DEA. Such officials must specify their agency and service identification number of the issuing official in lieu of a DEA registration number on any prescriptions for controlled substances. The service identification number for a public Health Service employee is his/her Social Security Number.

There are 2 ways to Dr can obtain permission to prescribe CS 3 True or False True 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).

A C B to enforce the controlled substance act D 4 Controlled Substance Act is designed to do which of the following? 4 Multiple choice A to improve the administration and regulation of the manufacture, distribution, and dispensing of CS B to enforce the controlled substance act C to provide an “open system” for distribution D both A and C

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.

Bureau of prison personal Which of the following practitioners require a DEA number to prescribe, dispense, or administer controlled substances? 5 Multiple choice A MILITARY DR. B Bureau of prison personal C DR. DDS DVM D Public Health Servants

Who must register with dea to prescribed CS ·A prescription order for a controlled substance may be issued only by a physician, dentist, podiatrist, veterinarian, mid-level practitioner

Pharmacy DEA registration must be renewed every..... 1. 1 year 2. 2 years 3. 3 years 4. 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 the registered 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-I C-II C-III C-IV C-V

Note question ·The substances in this schedule have a high abuse potential and no accepted medical use in the United States. This is the only schedule that includes drugs that are not available for prescribing, dispensing or administering ·Substances in Schedule II have a high abuse potential with severe psychological or physical dependence liability, have an accepted medical use in the United States, and are available for practitioners to prescribe, dispense and administer. ·The substances in this schedule have an abuse potential which is less than those in Schedule II, but more than Schedule IV substances. ·The substances in this schedule have an abuse potential less than those listed in Schedule III and more than substances in Schedule V.

Practitioner’s Use of a Hospital’s DEA Registration 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 address 2. serial number 3. date of dispensing 4. patient name 5. physician name 6. directions for use 7. 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 address 3. The Practitioner’s name, address, and registration number 4. 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 disposed of. 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 in Schedule III, IV and V). If this method is used, a prescription for a Schedule III, IV and V drug must be made readily retrievable Option 3 (Two separate files) • A file for all Schedule II-V controlled substances. If this method is used, a prescription for a Schedule III, IV and V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high. 8

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