Labeler code = 1st 5 numbers - identifies the distributor/manufacturer

Drug product code = middle 3 digits - identifies drug classe (unique to drug)

Package = last 2 digits - identifies amount in package

Labeler code = 05012 (1st 5 digits)

Drug product code = 050 (6th-8th digits)

Package = 04  (last 2 digits)

·        Name and address of the dispenser (pharmacy)

·        Serial number of the prescription

·        Date of the prescription or the date of its filling (or refilling)---state law often determines which date is to be used

·        Name of the prescriber

·        Name of the patient

·        Directions for use, including precautions, if any, as indicated on the prescription

·        Address of the patient

·        Initials of dispensing pharmacist

·        Telephone number of the pharmacy

·        Drug name, strength, and manufacturer’s lot number

·        Beyond-use date (if any)

·        Name of manufacturer or distributor

T/F: No person may sell, purchase or trade, offer to sell, purchase or trade or counterfeit a drug coupon.

such products are determined to be bioequivalent and are thus "therapeutically equivalent" to the brand name or reference product.

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

 Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Drugs in this schedule have currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions 

* abuse of the drug or other substance may lead to severe psychologic or physical dependence 

• New Application for Retail Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-Level Practitioner. 

• New Application for Manufacturer, Distributor, Researcher, Analytical Laboratory, Importer, Exporter 

• New Application for Domestic Chemical  

What does this DEA registration letters mean when it is the 1st letter of the DEA number?

A, B, M, F, P

A - dispenser

B- dispenser

M- midlevel practitioner

F - dispenser

P - distributor

5% of the total dosage units

distributor

1. Financial record

2. Sales record

3. Pricing record

1. Form is used to order non-CIIs (only C-I & IIs can be ordered using form 222)

2. Ordering more than 10 scheduled drugs on form 222

3. Erasing errors, instead of crossing them out

1. Notify the DEA, DPS and TSBP

2. Complete DEA form 106 and mail it to the above departments and keep on for your records.

$1,000; 

$20,000

C-I and C-II only 

- not for CIII to CIV due to less chance of abuse

____ must contain number of dosage units or volume dispensed, name and address of the person to whom the drug is dispensed, date, name/initials of dispensing pharmacist. 

      Inventories and records are to be kept under the federal and Texas regulations for ____years from the date such inventory and records are made

More than 8 ounces or 48 units of opium products ex. Donnagel PG; Parepectolin, Kapectolin PG, Kaolin Pectin P.G.

or 

> 4 ounces or 24 units of codeine - in Tx sale is prohibited without prescription

C1 & CII = mandatory

but an estimate for CIII-V

Annual inventory is required for all controlled substances plus all dosage forms of __and ___