Schedule 2 Drugs Henderson

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.

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.

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.

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.

Investigational drugs henderson

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

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.

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.

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