FILED 

 U.S. COURT OF APPEALS

 ELEVENTH CIRCUIT 

 2/17/03

 THOMAS K. KAHN 

 CLERK

[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

________________________

No. 94-3139

________________________

D. C. Docket No. 96-2461CV-DLG

UNITED STATES OF AMERICA,

Plaintiff-Appellee,

Cross-Appellant,

versus

WILLIAM O. STEELE,

Defendant-Appellant,

Cross-Appellee.

________________________

Appeals from the United States District Court

for the Northern District of Florida

_________________________

(July 29, 1998)

Before HATCHETT, Chief Judge, TJOFLAT, ANDERSON, EDMONDSON,

COX, BIRCH, DUBINA, BLACK, CARNES, BARKETT, HULL and

MARCUS, Circuit Judges.
2

CARNES, Circuit Judge:

William O. Steele, a pharmacist, was indicted for “knowingly and

intentionally dispens[ing]” controlled substances “in violation of Title 21,

United States Code, Section 841(a)(1).” The governing statute provides an

exception which permits pharmacists and other “practitioners” to dispense

controlled substances “to the extent authorized by their registration and in

conformity with other provisions of this subchapter,” 21 U.S.C. § 822(b), which

for present purposes means “in the course of professional practice,” 21 U.S.C.

§ 802(21). 

We granted en banc review to decide whether the indictment under which

Steele was convicted is defective because it does not negate the course of

professional practice exception. A panel of this Court answered that question

in the affirmative and reversed Steele’s conviction, United States v. Steele,117

F.3d 1231 (11th Cir. 1997), superceding , 105 F.3d 603 (1997), because it was

bound to do so by the prior panel decision in Outler v. United States, 659 F.2d

1306 (5th Cir. Unit B 1981). Because we are sitting en banc, we are not bound

by the Outler decision. Being free to overrule it, we hold that an indictment of

a practitioner for unlawfully dispensing drugs need not aver that it was done
3

outside the course of professional practice. We believe this conclusion is

compelled by 21 U.S.C. §885(a)(1) (“It shall not be necessary for the United

States to negative any exemption or exception set forth in this subchapter in any

. . . indictment . . . ”). 

The panel’s opinion, 117 F.3d at 1232 - 33, sets out the relevant facts, the

most pertinent of which concern the contents of the four-count indictment

returned against Steele for actions occurring while he was authorized as a

pharmacist to dispense controlled substances in the course of his professional

practice. Count one of the indictment charged:

 That from on or about July 1, 1993, and

continuously thereafter, up to and including on or about

November 2, 1993, in the Northern District of Florida,

the defendant, William O. Steele, did knowingly and

intentionally dispense hydromorphone hydrochloride,

a schedule II controlled substance, commonly known as

Dilaudid, in violation of Title 21, United States Code,

Section 841(a)(1).

117 F.3d at 1233. Counts two, three, and four are identical except that the

controlled substances named in them were Xanax, Valium, and Percodan,

respectively. The government’s theory of prosecution was that on numerous

occasions during the specified period, Steele dispensed those controlled
4

substances pursuant to prescriptions he knew to be forged . Steele maintained

that he did not know they were forged. The jury found that he did and convicted

him.

Steele contends there was insufficient evidence to convict, but the panel

did not reach that issue. Instead, it held that the indictment was defective

because it failed to allege that Steele dispensed the drugs outside the course of

his professional practice as a pharmacist. See, 117 F.3d at 1232, 1235. The

panel reached that holding reluctantly, because it believed that the plain

language of 885(a) (1) obviated the need for such an allegation. Nonetheless, the

panel felt bound to follow the holding in Outler, which was to the contrary. See

117 F.3d at 1235 & n.5 (“The holding in Outler stands in apparent conflict with

section 885(a)(1) . . . [but] . . . even if it conflicts with statutory law, we are

bound by Outler until such time as it is overruled.”) The panel was correct in

both respects. Under our prior precedent rule, a panel cannot overrule a prior

one’s holding even though convinced it is wrong. See, e.g., Cargill v. Turpin,

120 F.3d 1366, 1386 (11th Cir. 1997) (“The law of this circuit is ‘emphatic’ that

only the Supreme Court or this court sitting en banc can judicially overrule a

prior panel decision .”), cert. denied, ___ U.S. ___, 118 S. Ct. 1529 (1998);
5

United States v. Hogan , 986 F.2d 1364, 1369 (11th Cir. 1993) (“[I]t is the firmly

established rule of this Circuit that each succeeding panel is bound by the

holding of the first panel to address an issue of law, unless and until that holding

is overruled en banc, or by the Supreme Court.”). However, we are not bound

by Outler, and our examination of the relevant statutory provisions leads us to

conclude, as the panel in this case did, that Outler was wrongly decided.

21 U.S.C. § 841(a) provides: “Except as authorized by this subchapter,

it shall be unlawful for any person knowingly or intentionally (1) to . . .

dispense . . . a controlled substance . . . .” The subchapter referred to is

Subchapter I of Chapter 13 of Title 21, and that subchapter runs from § 801

through § 904.

One of the authorized exceptions to the proscription against dispensing

controlled substances is contained in 21 U.S.C. § 822(b), which specifies that

“Persons registered by the Attorney General under this subchapter to . . .

dispense controlled substances are . . . authorized to possess . . . or dispense

such substances . . . to the extent authorized by their registration and in

conformity with the other provisions of this subchapter.” “Dispense” means

“to deliver a controlled substance to an ultimate user or research subject by,
6

or pursuant to the lawful order of, a practitioner, including the prescribing and

administering of a controlled substance.” 21 U.S.C. § 802(10). An “ultimate

user” is “a person who has lawfully obtained . . . a controlled substance for his

own use or for the use of a member of his household,” 21 U.S.C. § 801(27), as

by prescription from a practitioner. The term “practitioner” is defined to include

“a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital,

or other person licensed, registered, or otherwise permitted, by the United States

or the jurisdiction in which he practices or does research, to distribute, [or]

dispense . . . a controlled substance in the course of professional practice or

research.” 21 U.S.C. § 802(21). 

The upshot of all those provisions is that because Steele was acting as an

agent of a registered pharmacy, he was authorized to dispense controlled

substances in the course of his professional practice as a pharmacist, but only

pursuant to a prescription issued by a practitioner. See 21 U.S.C. § 829 (a) -

(b). That is undisputed. What is disputed between the parties is the meaning and

effect of § 885(a)(1), which provides:

It shall not be necessary for the United States to

negative any exemption or exception set forth in this

subchapter in any . . . indictment . . . or in any trial . . .
7

and the burden of going forward with the evidence with

respect to any such exemption or exception shall be

upon the person claiming its benefit.

The meaning of that provision, as it relates to the issue before us, is evident from

its plain language: an indictment charging a violation of § 841(a) (1) need not

negate the course of professional practice exception contained in § 822(b). 

 “In construing a statute we must begin, and often should end as well,

with the language of the statute itself.” Merritt v. Dillard, 120 F.3d 1181, 1185

(11th Cir. 1997). Where the language Congress chose to express its intent is

clear and unambiguous, that is as far as we go to ascertain its intent because we

must presume that Congress said what it meant and meant what it said. See,

e.g., Connecticut Nat’l Bank v. Germain, 503 U.S. 249, 253 - 54, 112 S.Ct.

1146, 1149 (1992) (“We have stated time and again that courts must presume

that a legislature says in a statute what it means and means in a statute what it

says there.”). 

Steele argues that United States v. Moore, 423 U.S. 122, 96 S.Ct. 335

(1975), stands for the proposition that a practitioner may be convicted for

distributing and dispensing controlled substances only if the government pleads

and proves that those activities were outside the course of professional practice.
8

That is not what that case holds. Certiorari was granted in Moore to review a

court of appeals decision that 21 U.S.C. § 841 does not apply to registered

practitioners, such as the physician in that case, regardless of whether their

distributing and dispensing were in the course of professional practice. The

Supreme Court reversed, holding that § 841 does apply to registered

practitioners when their activities fall outside the usual course of professional

practice. See id. at 124, 96 S. Ct. at 336. However, the Court did not address

the issue of whether the outside the course of professional practice factor was

an element of the offense or whether the government was required to plead it in

the indictment. It is worthy of note that the indictment in the Moore case

alleged nothing about the course of professional practice. See Moore v. United

States, 506 F.2d 426, 446 n.2 (D.C. Cir. 1973) (dissenting opinion).

Steele also seeks support in United States v. Vuitch, 402 U.S. 62, 91 S. Ct.

1294 (1961), in which the Supreme Court stated: “It is a general guide to the

interpretation of criminal statutes that when an exception is incorporated in the

enacting clause of a statute, the burden is on the prosecution to plead and prove

that the defendant is not within the exception.” Id. at 70, 91 S. Ct. at 1298. The

government counters by quoting the general rule announced in McKelvey v.
9

United States, 260 U.S. 353, 357, 43 S. Ct. 132, 134 (1922), that: “[A]n

indictment or other pleading founded on a general provision defining the

elements of an offense . . . need not negative the matter of an exception made by

proviso or other distinct clause.” 

 Both the Vuitch and the McKelvey rules are rules of statutory

construction, or “general guide[s] to the interpretation of criminal statutes,”

Vuitch, 402 U. S. at 90, 91 S. Ct. at 1298, and as such they are useful when

Congress has not made its intent clear. In this case we have no need to rely

upon such rules of construction, because Congress has explicitly and

unambiguously stated in § 885(a)(1) that an indictment charging a defendant

with violating § 841(a)(1) is not required to negate the course of professional

practice exception. Congress could scarcely have been any clearer about that.

Steele protests that Congress could not have meant what it said in § 885(a)

(1), because that would mean prosecutors could indict each and every

pharmacist and doctor in the country for simply carrying out their professional

duties. In other words, if we apply the statute as written, the sky will fall, at

least on pharmacists and doctors. Of course, if the sky starts falling, it could just

as well fall on research scientists and on those who legitimately manufacture and
10

transport controlled substances, as well as on every legitimate, prescriptionholding ultimate user, because all are saved from the broad terms of §§

841(a)(1) or 844(a) by exceptions that are also subject to the provisions of §

885(a)(1).

Steele does not explain why busy government prosecutors would want to

indict any case that they are certain to lose when it goes to trial, if not sooner.

We seriously doubt that the Department of Justice would tolerate the continued

employment of any prosecutor who would do that. Steele’s argument about

government prosecutors indicting pharmacists and doctors for possessing and

dispensing controlled substances in the course of their professional practice also

fails to explain why that has not been a problem in the three circuits where the

conclusion we reach today has long been the law. Twenty years ago the Seventh

Circuit said that an indictment charging a physician with dispensing controlled

substances need not allege that the prescriptions he wrote were outside the

course of his professional practice. See United States v. Roya, 574 F.2d 386,

391 (7th Cir. 1978) (“An indictment founded on a general provision of a statute

need not negative an exception made by a proviso or other distinct clause,

whether in the same section or elsewhere.”). Eighteen years ago the Sixth
11

Circuit held that an indictment charging pharmacists with illegally distributing

controlled substances need not allege that they acted outside the usual course of

professional conduct. See United States v. Seelig, 622 F.2d 207, 211-12 (6th Cir.

1980). The same rule has been in effect in the Third Circuit for six years. See

United States v. Polan, 970 F.2d 1280, 1282 (3rd Cir. 1992) (indictment of

physician for distributing and conspiring to distribute controlled substance not

defective for failure to allege absence of legitimate medical reason). There has

been no report of prosecutors running amuck in any of those jurisdictions. In any

event, the concerns Steele puts forward implicate policy judgments that are

within the province of Congress.

It is not the courts but Congress that defines crimes and defenses in the

United States Code. Subject only to constitutional constraints, it has the

authority to specify whether a given factor must be pleaded by the government

in the indictment as an element of an offense, or affirmatively raised by the

defense as part of its case. Steele contends that Congress overstepped its bounds

with §885(a)(1), because the course of professional practice factor is an

element of the § 841(a)(1) offense, and all elements must be alleged in the

indictment, see, e.g., Russell v. United States, 369 U.S. 749, 763, 82 S.Ct.
12

1038, 1047 (1962). An essential premise of that syllogism is that the course of

professional practice factor is an element and not a defense, but that is not what

Congress said when it definitively exercised its right to say. Instead, Congress

said that the course of professional practice exception, indeed all exceptions to

the prohibition against manufacturing, distributing, dispensing, and possessing

controlled substances, are defenses not elements, and that their inapplicability

need not be alleged in the indictment.

An indictment is sufficient “if it: (1) presents the essential elements of the

charged offense, (2) notifies the accused of the charges to be defended against,

and (3) enables the accused to rely upon a judgment under the indictment as a

bar against double jeopardy for any subsequent prosecution for the same

offense.” United States v. Dabbs, 134 F.3d 1071, 1079 (11th Cir. 1998). 

Because the indictment in this case does all of that, it is not defective.

In holding that an indictment charging a practitioner with violating 21

U.S.C. § 841(a)(1) need not negative the course of professional practice

exception, we join the Third, Sixth, and Seventh Circuits, see Polan, Seelig, and

Roya, and we return to the pre-Outler position our predecessor Court took in

United States v. Ramzy, 446 F.2d 1184 (5th Cir. 1971), which involved an earlier
13

version of the current Controlled Substances Act. Like the other three circuits,

we part company with the Ninth Circuit’s position on this issue, see United

States v. King, 587 F.2d 956, 962-65 (9th Cir. 1978) (two-to-one decision). One

problem with the Ninth Circuit’s majority opinion in King, as the Sixth Circuit

has pointed out, see Polan, 970 F.2d at 1283, is that its analysis of this specific

issue fails to focus upon § 885(a)(1), the key provision upon which the issue

turns. The same is true of the opinion in Outler, the decision which we overrule

today.

We have decided only a pleading issue – that the course of professional

practice exception is an affirmative defense which need not be negated in the

indictment. We have no occasion to address the issue of who bears the burden

of persuasion, and how heavy that burden is, once the defendant goes forward

with the evidence about it as § 885(a)(1) requires. The burden of persuasion

issue is of no significance to the conviction under review in this case, because

the district court instructed the jury that the government bore that burden and

could discharge it only by proof beyond a reasonable doubt. Whether a

defendant is entitled to such an instruction is an issue we have no occasion to

address.
14

Steele does raise other issues relating to his conviction that have not yet

been addressed because the panel did not reach them. We express no view on

those other issues, choosing instead to let the panel decide them. The same is

true of the sentencing issue raised in the government’s cross-appeal.

Having decided the issue on which we granted en banc review, this case

is REMANDED TO THE PANEL for decision of the other issues raised in the

appeal and the cross-appeal.
15

EDMONDSON, Circuit Judge, Concurring:

Today’s court relies heavily on what we see as the plain language

of the pertinent statute. I agree with the opinion and with the result.

But I point out that we do not have before us today a statute that was

enacted long ago. When those much older statutes are being construed

by modern courts, our response as modern readers to the words of the

statute may not be what the words meant to the Congress speaking at

a very different time; and the idea of plain meaning becomes far more

complicated.