Can Tennessee require a prescription for all pseudoephedrine products, even though federal law doesn't?

Subject

Opinion No. 13-108, Prescription Requirement for Pseudoephedrine Products, December 20, 2013

Plain-English summary

Sen. Mae Beavers asked whether Tennessee can require a prescription for all products containing pseudoephedrine, even though pseudoephedrine isn't on the federal DEA's list of scheduled narcotics. The AG said yes.

State police power covers this. State laws regulating the sale of drugs, medicines, and poisons are an appropriate exercise of the state's police power to protect public health. State v. Foutch, 155 Tenn. 476, 479 (1927). The only barrier to state action would be federal preemption under the Supremacy Clause, U.S. Const. art. VI, cl. 2.

The federal preemption question. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) imposes national uniformity on the regulation of nonprescription drugs through 21 U.S.C. § 379r. Without an exception, § 379r would preempt a state's prescription requirement for an OTC drug.

But § 379r(c)(1)(B) saves Tennessee's authority. The statute expressly carves out, from preemption:

any state or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.

That carve-out is unambiguous. Tennessee may, by statute, require that pseudoephedrine products be dispensed only with a prescription from a Tennessee-licensed practitioner. The fact that the federal DEA hasn't scheduled pseudoephedrine is irrelevant; federal scheduling and state Rx requirements are independent decisions.

Important contrast with Op. 13-99. Earlier the same year, Op. 13-99 (Dec. 6, 2013) held that a local (city or county) ordinance making pseudoephedrine prescription-only would be preempted by Tennessee's state law in § 39-17-431. Op. 13-108 clarifies that state-level action is different: the General Assembly itself can enact a prescription requirement; the field preemption it has asserted blocks municipal action but doesn't bind the legislature itself.

Currency note

This opinion was issued in 2013. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.

Whether Tennessee subsequently adopted a state-level prescription requirement for pseudoephedrine, or kept the current limit-and-track scheme in Tenn. Code Ann. § 39-17-431, is a question for current legislative records. The federal preemption analysis (§ 379r(c)(1)(B) carve-out) has remained stable.

Background and statutory framework

State police power over drug sales. Tennessee, like every state, regulates the practice of pharmacy and the sale of drugs as a matter of public health. The Constitution allocates this power to the states. State v. Foutch recognized that drug regulation is a core state function.

Federal preemption doctrine. Federal law preempts state law when Congress has expressed clear and manifest purpose to occupy the field, either expressly in the statute or impliedly from its structure. State v. Scott, 678 S.W.2d 50, 51 (Tenn. 1984); Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947); Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141 (1982).

21 U.S.C. § 379r. Establishes general preemption for state OTC drug requirements. Subsection (c)(1) lists exceptions to that preemption:

(c)(1) This section shall not apply to—
. . .
(B) any state or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.

The other exceptions in (c)(1) cover good manufacturing practice rules, reactive drug-product testing rules, and similar items. The (B) carve-out is the one relevant here.

The federal CMEA backdrop. The Combat Methamphetamine Epidemic Act of 2005 (21 U.S.C. § 830 et seq.) imposes federal limits on OTC pseudoephedrine sales (daily and 30-day caps, behind-counter, logbook) but doesn't preempt stricter state action.

Why states might choose a prescription requirement. Oregon (2006) and Mississippi (2010) had moved to prescription-only pseudoephedrine before this opinion. Both reported significant declines in meth lab incidents. Other states (including Tennessee at the time of this opinion) used limit-and-track schemes. Op. 13-108 doesn't recommend a policy; it just confirms Tennessee has the legal authority to choose.

Common questions

Does this mean Tennessee already requires a prescription?

No. The opinion confirms Tennessee could enact one. As of 2013, Tennessee's scheme in Tenn. Code Ann. § 39-17-431 imposed strict caps and behind-counter sales but not a blanket prescription requirement.

What about a county making it prescription-only?

That's the question Op. 13-99 (Dec. 6, 2013) answered: no, because § 39-17-431 preempts local enactments. Op. 13-108 addresses the state's authority, which is unconstrained.

Does the federal Combat Methamphetamine Epidemic Act prevent state action?

No. CMEA sets a floor, not a ceiling. § 379r(c)(1)(B) and CMEA's own savings clauses preserve state authority to go further.

Could Tennessee make pseudoephedrine prescription-only just for certain populations or with carve-outs?

The opinion didn't address narrower variants. The state's general authority to enact prescription requirements is well-established; specific carve-outs would have to be analyzed for equal protection or other doctrinal issues.

What's the practical difference between "prescription-only" and the current limit-and-track scheme?

A prescription requirement eliminates over-the-counter sales entirely; consumers need to see a healthcare provider to get pseudoephedrine. The limit-and-track scheme allows OTC sales but tracks them across stores. Each approach trades off consumer convenience against meth prevention differently.

Citations

U.S. Const. art. VI, cl. 2 (Supremacy Clause). 21 U.S.C. §§ 301 et seq. (FDCA); 21 U.S.C. § 379r (OTC drug preemption); 21 U.S.C. § 379r(c)(1) (preemption carve-outs). Tenn. Code Ann. § 39-17-431. Cases: State v. Foutch, 155 Tenn. 476 (1927); State v. Scott, 678 S.W.2d 50 (Tenn. 1984); Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947); Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141 (1982). Prior AG opinion: Op. 13-99 (Dec. 6, 2013).

Source

• Landing page: https://www.tn.gov/attorneygeneral/opinions.html
• Original PDF: https://www.tn.gov/content/dam/tn/attorneygeneral/documents/ops/2013/op13-108.pdf

Original opinion text

December 20, 2013

Opinion No. 13-108

Prescription Requirement for Pseudoephedrine Products

QUESTION

May the State of Tennessee require that all products containing pseudoephedrine be sold only with a valid prescription from a Tennessee licensed health-care professional, even though pseudoephedrine is not contained on the federal Drug Enforcement Agency's list of scheduled narcotics?

OPINION

Yes.

ANALYSIS

State laws regulating the sale of drugs, medicines, and poisons are an appropriate exercise of the state's police power to protect the public health. State v. Foutch, 155 Tenn. 476, 479 (1927). While a state's police power may be preempted under the Supremacy Clause of the United States Constitution, see U.S. Const. art. VI, cl. 2, by federal regulation where that was Congress' clear and manifest purpose, preemption is compelled only if it is expressly stated in the federal law or is implied in the law's structure and purpose. State v. Scott, 678 S.W.2d 50, 51 (Tenn. 1984) (citing Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947) and Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141 (1982)).

The Federal Food, Drug, and Cosmetic Act contains various provisions relating to prescription and non-prescription drugs. See 21 U.S.C. §§ 301, et seq. One section of the act imposes national uniformity in the regulation of non-prescription drugs and preempts state requirements concerning over-the-counter medications. See 21 U.S.C. § 379r. Thus, without any statutory exemption, § 379r would preempt a state from enacting a prescription requirement for pseudoephedrine. However, § 379r(c)(1) carves out an exception, stating:

This section [§ 379r] shall not apply to—
. . .
(B) any state or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.

This statute expressly removes any preemption by federal law of a state's authority to enact a prescription requirement for drugs such as pseudoephedrine. Therefore, the General Assembly could legitimately enact a law requiring that products containing pseudoephedrine be sold only with a valid prescription from a Tennessee licensed health-care professional.

ROBERT E. COOPER, JR.
Attorney General and Reporter

GORDON W. SMITH
Associate Solicitor General

SARA E. SEDGWICK
Senior Counsel

Requested by:

The Honorable Mae Beavers
State Senator
6 Legislative Plaza
Nashville, Tennessee 37243

This Office has recently opined in Tenn. Att'y Gen. Op. 13-99 (Dec. 6, 2013) that enactment by a Tennessee county or municipality of a local ordinance that prohibits the sale, delivery or distribution of over-the-counter products containing ephedrine or pseudoephedrine without a valid prescription from a health care professional licensed in Tennessee would violate Tenn. Code Ann. § 39-17-431.