Overview
This lecture explains behind-the-counter (BTC) drugs, their regulatory requirements, and the responsibilities of pharmacy technicians in dispensing these medications.
What Are Behind-the-Counter (BTC) Drugs?
- BTC drugs are non-prescription medications kept behind the pharmacy counter due to misuse potential.
- These drugs may require pharmacist approval or have purchase limits.
- BTC medications are intended to protect consumers from dependency, addiction, or illegal use.
Examples of BTC Medications
- Cough syrups containing guaifenesin and codeine are BTC and classified as Schedule V controlled substances.
- Emergency contraceptives are BTC; buyers must be at least 17 years old with valid ID and recorded purchase.
- Products with ephedrine, pseudoephedrine (Sudafed), or phenylpropanolamine are BTC to prevent illegal methamphetamine production.
- Phenylpropanolamine is no longer available in the US but pseudoephedrine is tightly regulated.
Regulations for BTC Drugs
- The Combat Methamphetamine Epidemic Act of 2005 sets strict rules for BTC sales.
- Customers must present valid identification for purchases.
- Pharmacy technicians must record the buyer’s name, address, date/time, and amount purchased.
- Records of BTC sales must be kept for at least 2 years.
- BTC sales limits: max 3.6 grams/day or 9 grams/month of active ingredient (excluding salts).
- All non-liquid forms must be sold in two-unit blister packs or, if not feasible, in unit dosage packets.
Role of Pharmacy Technicians
- Technicians must follow all BTC drug regulations precisely to prevent misuse.
- Maintaining accurate records and staying updated on laws is crucial for consumer safety.
Key Terms & Definitions
- Behind-the-counter (BTC) drugs — Non-prescription drugs sold under special controls behind the pharmacy counter.
- Schedule V medications — Drugs with lower abuse potential and accepted medical use.
- Pseudoephedrine (PSE) — A BTC decongestant regulated due to methamphetamine production risks.
- Combat Methamphetamine Epidemic Act of 2005 — Law restricting sale of ingredients used in methamphetamine production.
Action Items / Next Steps
- Review all current regulations related to BTC drugs in your state or country.
- Practice documenting sales information for BTC products accurately.
- Stay informed about changes to controlled substance laws affecting pharmacy practice.