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1

Federal Controlled Substance Act

-1970
-Claiming that controlled substances can have a legit, medical purpose that can increase the public's welfare
-Illegal importation, manufacturing, distributing, and possessing of controlled substances is detrimental to the public
-Provides definitions of terms relating to controlled substances and their abuse, examples of classes of drugs that may be abused, dispensing and record laws, etc.

2

Addict

-Any individual who habitually uses ANY narcotic so as to endanger the public morals, health, safety, or welfare
-Also those who have lost the power of self-control regarding addiction

3

Agent

Authorized person who acts on behalf of manufacturer, distributor, or dispenser

4

Controlled Substance

Drug or substance or immediate predecessor in schedule I-V
**Not spirits, tobacco, wine, malt drinks**

5

Depressant or Stimulant

-Any drug with barbituric acid
-Drug with amphetamine
-Drug with lysergic acid diethylamide
-Drug with any amount of substance that could be potentially abused for its depressing or stimulating effects

6

Dispense

-Delivery of a controlled substance to its ultimate user or research subject lawfully
-Includes appropriate packaging, labeling, etc. required

7

DEA's Mission

-Enforce the controlled substances law and regulation of the US
-Bring to the criminal and civil justice system of the US those involved in growing, manufacturing, or distributing substances destined for illicit trafficking in the US

8

Pharmacist Manual

-Federal regulations and DEA law are extension and detailed, good place to find this info
-Guide to pharmacists specifically to aid pharmacy practice
-Compiles the pertinent information from Fed. Controlled Act

9

CI

-High risk for abuse
-No accepted medical use in treatment or lacks accepted safety for use under medical supervision

10

CII

-High potential for abuse
-Accepted medical use
-May lead to severe psychic or physical dependence

11

CIII

-Less potential for abuse than CI or CII
-Accepted medical use
-Moderate or low risk of physical dependence or high psychological dependence

12

CIV

-Low potential for abuse compared to CIII
-Accepted medical use
-Limited physical or psychological dependence compared to CIII

13

CV

-Accepted medical use
-Limited physical or psychological dependence compared to CIV

14

SLCP

-Schedule Listed Chemical Product
-Non-Rx containing ephedrine, PSE, or PPA
-In NM, PSE is a CV

15

DEA Number

-1st Letter = related to practitioner level (A, B, F, M are mid-level practitioners, X = suboxone)
-2nd Letter = practitioner's last name
-Sum 1 = First number + Third number + Fifth number
-Sum 2 = Second number + Fourth number + Sixth number
-Sum 3 = Sum 1 + 2 * Sum 2
-Last number of the DEA should be the last number of Sum 3

16

Inventory Requirement

1. DEA - requires biennial inventory (every 2 years)
2. NM BoP - annual Cs inventory on May 1st, actual taking of inventory should be within 4 days of this date
-CII: actual counts
-CIII - CV: estimates are okay unless the container holds >1,000, then need to manually count
**Pharmacy policy may require a running inventory and keeping track of counts in real time**

17

Storage

-CII-CV: store in either securely locked cabinet or dispersed through stock
-CII usually kept in safe and CIII-CV usually found in stock
-PSE, Ephedrine, and PPA must be behind the counter or locked in a cabinet

18

CII Dispensing

1. Amount must be consistent with medical purpose (usual course of practice) and insurance limits to 7 or 30 days usually
2. Can issue up to 90 days in three 30 day prescriptions with the same written date and different earliest fill dates
3. Fill within 6 months of date written or earliest fill date

19

CII Dispensing - Partial Fills

May occur if:
-Dispensed number doesn't exceed the total prescribed
-Partial amount is recorded on written or electronic Rx
-Remaining portion filled before script's 30 days after the date written (or earliest fill date)

20

CII Dispensing - Initially filled after 30 days after date written

Can be partially filled if:
1. RPh is unable to dispense total prescribed
2. Amount is recorded on Rx
3. Remaining amount is filled in the next 72 hours
4. RPh notifies prescriber that remainder can't be filled in 72 hours

21

Dispensing CIII-CV

1. Can be dispensed up to 90 days
2. Can be telephoned in (exluding CIII-CV opiates) for up to a 10 day supply unless the same medication is on file from the last six months, NO REFILLS (Verbal authorizations or clarifications on refills don't count towards this)
3. Continuing therapy for CIII-CV non-opiate may be written or faxed for a 30-90 day supply
4. PSE containing products are available OTC
**Store/pharmacy policy can vary on these**

22

PSE

-If buying OTC without Rx, must have a government issues, photo, valid ID
-Pharmacy must keep a log of purchases and submit the data to BoP agency every 7 days
-3.6 g/day and 9 g/30 days

23

CII Refills

-NO REFILLS
-Partial fills with remainder within 72 hours (call doctor if this isn't possible)
-LTCF or "terminally ill" can be partially filled an unlimited number of times for 60 days up to total number of prescribed pills

24

CIII-CV Refills

-Recorded in same manner as any refill
-May refill up to 5 times
-Valid for 6 months after date of issue
-Don't refill before 75% of prescription's days supply has past

25

Controlled Transfers

-CII: NO TRANSFERS
-CIII-CV: to another pharmacy with real-time, online database, may transfer for up to max refills permitted by law (Walgreens to Walgreens for example)
-To any other pharmacy, can only be transferred ONCE