5.5 Non-Prescription CS Sales & Restricted OTC Products (CMEA)

5.5 Non-Prescription CS Sales & Restricted OTC Products (CMEA)

Quick Answer: The blueprint line "procedures for sales of CS and restricted OTCs (e.g., pseudoephedrine)" covers two separate regulatory schemes that candidates constantly merge. 21 CFR § 1306.26 governs dispensing a controlled substance without a prescription — a pharmacist-only transaction, limited to 240 cc (8 oz)/48 dosage units of an opium-containing product or 120 cc (4 oz)/24 dosage units of any other, per purchaser per 48 hours, to a purchaser at least 18 years old, recorded in a bound record book. 21 CFR Part 1314 implements the Combat Methamphetamine Epidemic Act of 2005 (CMEA) for scheduled listed chemical products (SLCPs) — ephedrine, pseudoephedrine, and phenylpropanolamine — with a 3.6 g base per calendar day limit, a 9 g per 30 days limit, behind-the-counter placement, photo ID, a signed logbook, and annual self-certification. SLCPs are chemicals, not controlled substances, which is why their theft is reported on DEA Form 107, not Form 106.

---

Part A — Dispensing Without a Prescription (21 CFR § 1306.26)

A controlled substance in Schedules II, III, IV, or V that is not a prescription drug under the Federal Food, Drug, and Cosmetic Act may be sold at retail without a prescription. In practice this means a narrow set of Schedule V preparations — codeine-containing antitussives and opium-containing antidiarrheals — and only where state law permits it. Many states have eliminated the transaction entirely; § 1306.26(f) makes the federal permission conditional on no other federal, state, or local law requiring a prescription.

The seven conditions

Why this section matters to a diversion program

The § 1306.26 transaction is the only routine pathway by which a controlled substance leaves a pharmacy without a prescription record. Its diversion signature is therefore a record-based one: entries in the bound book clustered around one purchaser, entries that skip the 48-hour spacing, entries initialed by a pharmacist who was not on duty, missing addresses, or — most commonly — product moving off the shelf faster than the book accounts for, which indicates sales made by technicians without pharmacist involvement. Reconciling the bound book against purchase invoices and on-hand count is a standard audit and belongs on the internal audit calendar described in Section 3.4.

Trap: the pharmacist-only rule is about the professional decision and the record, not the register. A technician ringing up the sale after the pharmacist has counseled, identified the purchaser, and made the book entry is compliant. A technician making the sale decision is not.

---

Part B — Restricted OTC Products: CMEA and Scheduled Listed Chemical Products

Scheduled listed chemical products (SLCPs) are over-the-counter products containing ephedrine, pseudoephedrine, or phenylpropanolamine — List I chemicals that are methamphetamine precursors. They are not controlled substances, but CMEA imposes a controlled-substance-like framework on their retail sale.

Quantity limits

┌─────────────────────────────────────────────────────────────────────────────┐
│                     CMEA SALES LIMITS (BASE WEIGHT)                         │
│                                                                             │
│  3.6 GRAMS  per purchaser, per CALENDAR DAY, per chemical                   │
│             • Applies without regard to the number of transactions          │
│             • Applies even if state law requires a prescription             │
│             • 21 CFR § 1314.20(a)                                           │
│                                                                             │
│  9 GRAMS    per individual, per 30-DAY period                               │
│             • Of which not more than 7.5 g may be imported by private or    │
│               commercial carrier or the U.S. Postal Service                 │
│             • 21 U.S.C. § 844(a)                                            │
│                                                                             │
│  7.5 GRAMS  per individual, per 30-DAY period, from a MOBILE RETAIL VENDOR  │
│             • 21 CFR § 1314.20(b)                                           │
└─────────────────────────────────────────────────────────────────────────────┘

The limits are expressed in grams of chemical base, not grams of salt. Pseudoephedrine hydrochloride has a molecular weight of about 201.7 while the free base is about 165.2, so the base fraction is roughly 0.82. A 30 mg pseudoephedrine HCl tablet therefore contributes about 24.6 mg of base.

Worked example. A purchaser wants three 48-count boxes of pseudoephedrine HCl 30 mg in one day.

• Total salt: 3 × 48 × 30 mg = 4,320 mg = 4.32 g pseudoephedrine HCl
• Base equivalent: 4.32 g × 0.82 ≈ 3.54 g base
• 3.54 g < 3.6 g, so the daily limit is not exceeded — but the purchaser has consumed almost the entire day's allowance in one transaction, and the sale still must be logged and counted against the 9 g/30-day ceiling.

Adding a fourth box (another 1.18 g base, for ≈ 4.72 g) would exceed the daily cap and must be refused. Point-of-sale systems and the multi-state National Precursor Log Exchange (NPLEx) perform this arithmetic in real time and return a stop-sale when a purchaser has hit a federal or state threshold, including purchases made at other stores.

Placement, packaging, and delivery

The logbook (21 CFR § 1314.30)

The written (bound) or electronic logbook must identify each sale by:

1. Name of the purchaser
2. Address of the purchaser
3. Date and time of the sale
4. Name and amount of the product sold

Process requirements:

• The purchaser must present a photo identification issued by a state or the federal government (or another form acceptable under 8 CFR § 274a.2(b)(1)(v)(A)–(B)).
• The purchaser signs the logbook — entering name, address, date, and time in a written book, or signing electronically.
• The seller verifies that the name in the logbook matches the identification and that the date and time are correct, and enters the product name and quantity sold.
• The logbook must display the 18 U.S.C. § 1001 warning that false statements are punishable by fines up to $250,000 for an individual or $500,000 for an organization and up to five years imprisonment.
• Entries must be retained for not fewer than two years after the date of the entry.
• Logbook exemption: a purchase by an individual of a single sales package containing not more than 60 mg of pseudoephedrine does not require a logbook entry.
• Privacy: logbook information may be disclosed only to federal, state, and local law enforcement and to DEA, or to facilitate a product recall (§ 1314.45).

High-yield trap: pharmacies must maintain the CMEA logbook and observe the 3.6 g daily limit even if state law requires a prescription for pseudoephedrine. A state prescription requirement layers on top of the federal rules; it does not replace them (§ 1307.02, the stricter-law principle).

Self-certification and training

• A regulated seller must self-certify to DEA online before selling SLCPs, certifying that it understands the requirements and that all employees who deliver the product to purchasers or take payment have been trained (§§ 1314.35, 1314.40).
• Self-certification is renewed annually after the initial certification period, and a separate certification is required for each place of business.
• The fee is $21 per certification and is waived for a person holding a current DEA registration in good standing as a pharmacy (§ 1314.42).
• The seller keeps a copy of each self-certification and the training records.

Loss or theft of SLCPs — Form 107, not Form 106

When scheduled listed chemical products are stolen or lost:

1. Make an oral report to the local DEA Diversion Field Office at the earliest practicable opportunity after becoming aware of the circumstances (21 CFR § 1314.15(b)).
2. File a written report on DEA Form 107 within 15 days of becoming aware of the loss or theft (21 CFR § 1314.15(c)), submitted through DEA's secure online application.
3. The report includes the DEA registration number (if applicable), name, business address, telephone number, date of loss, type of loss, and a description of the circumstances — for example, in-transit or theft from the premises (§ 1314.15(e)).

Contrast this with DEA Form 106, which covers controlled substances and carries the one-business-day written notification plus the 45-day filing window taught in Section 5.4. Choosing between Form 106 and Form 107 on the exam turns on one question: is the missing product a controlled substance or a listed chemical?

---

Employment Measures

21 CFR § 1314.50 permits a regulated seller to take reasonable measures to avoid employing individuals who present a theft or diversion risk with respect to SLCPs, including — notwithstanding state law — asking applicants whether they have been convicted of any crime involving or related to those products or to controlled substances. This mirrors the employee-screening guidance in § 1301.90 discussed in Section 3.4.