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 could require a prescription for all products containing pseudoephedrine, even though pseudoephedrine was not on the federal Drug Enforcement Agency's list of scheduled narcotics. The Attorney General answered yes: the General Assembly could enact such a law.

The opinion explains that regulating drug sales falls within the state's police power, which federal law can preempt. A provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 379r, generally preempts state requirements concerning nonprescription drugs. But § 379r(c)(1) says that the provision does not apply to a state requirement that a drug be dispensed only on a licensed practitioner's prescription. The Attorney General concluded that this exception removes the federal preemption obstacle to Tennessee's proposed requirement.

A footnote addresses a different level of government. It cites Op. 13-99, which concluded that a Tennessee county or municipality would violate Tenn. Code Ann. § 39-17-431 by enacting a local prescription ordinance for over-the-counter products containing ephedrine or pseudoephedrine.

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.

What this means for you

If you are evaluating a proposed statewide prescription requirement, this opinion answers whether the federal nonprescription-drug preemption provision would bar it. It does not analyze other possible legal objections or say that Tennessee enacted the proposal. If you are evaluating a county or city ordinance, read the separate state-law conclusion identified in the footnote to Op. 13-99.

Common questions

Did the Attorney General say Tennessee already required prescriptions for pseudoephedrine?

No. The question was whether the General Assembly could enact a prescription requirement. The opinion did not report that it had done so.

Can a Tennessee county or city impose its own prescription requirement?

The footnote reports that Op. 13-99 found a local ordinance prohibiting over-the-counter ephedrine or pseudoephedrine sales without a valid prescription would violate Tenn. Code Ann. § 39-17-431. Op. 13-108 answers the question about state legislation.

Did the opinion decide that Tennessee has unrestricted authority over pseudoephedrine?

No. It addresses whether the federal preemption provision in 21 U.S.C. § 379r bars the proposed state prescription requirement. Its conclusion rests on that provision's prescription exception.

Does the absence of pseudoephedrine from the federal scheduled-narcotics list change the answer?

That absence was part of the senator's question. The Attorney General still concluded that the General Assembly could enact the proposed requirement, based on the exception to § 379r.

Citations

U.S. Const. art. VI, cl. 2 (Supremacy Clause). 21 U.S.C. §§ 301 et seq. (Federal Food, Drug, and Cosmetic Act); 21 U.S.C. § 379r (nonprescription-drug preemption). Tenn. Code Ann. § 39-17-431 (cited in footnote). 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.¹

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

¹ 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.