1. Schedule 2 Drugs
Henderson

2. Controlled Substance Inventory
The pharmacy is required to take “initial inventory” when it is issued a DEA registration number.
The pharmacy is required to take a biennial inventory (every two years).
The pharmacy is required to take inventory if a drug is newly introduced.

3. Requirements of said inventory
All CIIs must be counted to the exact count or measure.
If the substance is schedule III-V estimations are accepted unless the container holds more than 1000 units in which case, an exact count is required.
The pharmacist in charge in required to sign and date inventory for records.

4. CII Perpetual Inventory
EVERY dispensing and receiving of any CII is to be documented in a book. This is to be kept accurate and up to date at all times.

5. Storage of CIIs
All CIIs are to be kept in a locket cabinet/safe OR dispersed throughout the pharmacy stock.
Keys of the locked cabinet/safe are to be kept on the pharmacist.

6. Investigational drugs
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7. Steps in development of new drugs
Preclinical Testing
Drugs are tested for toxicity, pharmacokinetics (use of the drug in the body), and possible useful effects
Animal testing: Range of 1-3 years, usually 18 months FDA safety review follows
Investigational New Drug Status if Approved
(go back to earliest research if not approved)
Clinical Trials in Humans
Range of 2-10 years, usually 5 years

8. Phases of Investigational drugs
Phase I
Subjects are normally volunteers with a specific disease to be treated by the new drug
Trials test for therapeutic use, dosage range, and effects in humans.
Usually 5-20 volunteers who need to sign a consent which they are allowed to remove themselves from the study at any time.

9. Phases of Investigational drugs
Phase II
Subjects are patients who are closely monitored
Trials test for therapeutic use, dosage range, and safety
Phase III
Subjects are patients
Trials test for safety and effectiveness with more precise definitions of adverse effects
Phase IV
Post marketing trials
No control groups involved
All remaining investigational drugs should be returned to the person(s) responsible for the drug.

10. Steps in development of new drugs
New Drug Application (NDA) sent to FDA
FDA review: Range of 2 months to 7 years, usually 24 months
FDA Approval of NDA
If not approved, return to initial testing or further research
Post marketing Surveillance
Drug is released for use, permitting observation in large numbers of patients
Adverse reactions are reported using MedWatch Form 3500