Texas vs. Federal Laws Controls

Question 1

Opium & Codiene related products sales

Answer 1

1. Federal - Allows OTC “exempt” sales of C-V products with codeine
2. Texas - Does not allow OTC “exempt” sales of C-V products containing codeine. (All codeine requires an Rx).

Question 2

Opium-Containing Products Schedules - C-V vs Others?

Answer 2

1. Federal: Maxium for C-V: 100mg/100ml

2. Texas: Max for C-V: 50mg/100ml - Anything else is a C-III or C-II rx.

Question 3

C-V Prescription Refill Limits

Answer 3

1. Federal: Not limited to 5 refills/6 months

2. Texas: Refills limited to 5 refills/6 months

Question 4

C-II Prescribing

Answer 4

1. Texas requires a special Rx

Question 5

C-II time limits

Answer 5

1. Federal: No time limit.

2. Texas: 21 days from date issued or first date of authorized fill.

Question 6

Control Automatic Refills

Answer 6

1. Federal: Not addressed
2. Texas: Not Addressed in Texas Control Substance Act.

Tx BoP – Allows for pharmacies to implement automatic refills for C-IV & C-V

Question 7

Controlled substance emergency refills?

Answer 7

Schedule II
1. Federal: Not allowed

2. Texas: Not allowed

Schedule III-V
1. Federal: Not Addressed

2. Texas: Address in TCSA and through BoP - Allow emergency refills using RPh judgement.

Question 8

Controlled substance inventories

Answer 8

1. Federal: Every 2 years
2. Texas: Every 2 years (TCSA)
   Tx BoP: Require annually and needs signature from PIC and notorized within 3 days from day taken.

Question 9

Controlled Substance security storage req.

Answer 9

1. Federal: May be stored in locked cabinet or throughout the non-controlled inventory.
2. Texas: TCSA - Same as fed.

TxBoP: Specifically requires
Class C & C-S (Institutional), C-A (Ambulatory surgical centers),
F (Free-Standing Emergency Medical Facilities) pharmacy to have locked storage for C-IIs.

Question 10

How should prescriptions be filed? (Federal)

Answer 10

3 options allowed.

1. Two files: One w/all controlled substances one with all noncontrolled substances
2. Two files: One with C-II’s on with all others.
3. Three files: One with C-IIs, One with C-III - C-V, one with dangerous drugs and other noncontrolled OTCs.

Question 11

How should prescriptions be filed? (Texas)

Answer 11

TSBP requires the three style storage method.

File 1: C-II
File 2: C-III - C-V
File 3: Dangerous drugs and noncontrolled OTC’s.

Question 12

How should control substance invoices be handled in Texas?

Answer 12

Invoices for inbound CS’s must have initials of pharmacist along with actual date of receipt recorded on invoice.

(In Class C ambulatory surgical centers & free standing emergency medical facilities- invoice may be initialed by receiver as there may be no pharmacist present)

Question 13

Prescription Requirements - Quantity and Refill limits for controlled substances

Answer 13

Federal - No quantity limit on opioid Rx’s (or any control) on a singal Rx, no special opioid rules.

Texas - Opioid prescriptions for acute pain have a 10-day limit and cannot be refilled.