United States Court of Appeals

For the First Circuit 

Nos. 16-2402 

 16-2403 

 16-2404 

UNITED STATES OF AMERICA, 

Appellant, 

 v. 

ALLA V. STEPANETS; KATHY S. CHIN; MICHELLE L. THOMAS, 

 Defendants, Appellees. 

APPEALS FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 

[Hon. Richard G. Stearns, U.S. District Judge] 

Before 

Torruella, Thompson, and Kayatta, 

Circuit Judges. 

 Daniel Tenny, Attorney, Appellate Staff, Civil Division, U.S. 

Department of Justice, with whom Chad A. Readler, Acting Assistant 

Attorney General, William D. Weinreb, Acting United States 

Attorney, Amanda P.M. Strachan, Assistant United States Attorney, 

George P. Varghese, Assistant United States Attorney, Douglas N. 

Letter, Attorney, Appellate Staff, and Scott R. McIntosh, 

Attorney, Appellate Staff, were on brief, for appellant. 
 John H. Cunha Jr., with whom Cunha & Holcomb, P.C. was on 

brief, for appellee Stepanets. Michael C. Bourbeau, with whom 

Bourbeau & Bonilla, LLP was on brief, for appellee Thomas. 

Joan M. Griffin for appellee Chin. 

January 12, 2018 

 
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THOMPSON, Circuit Judge. 

Preface

The government appeals from orders dismissing counts in 

an indictment that charged Alla Stepanets, Kathy Chin, and Michelle 

Thomas with "dispens[ing]" misbranded drugs in violation of the 

Federal Food, Drug, and Cosmetic Act, see 21 U.S.C. §§ 353(b)(1), 

331(a), and 333(a)(2) — a statute that often goes by the 

unpronounceable initialism "FFDCA." Reviewing the matter de novo, 

see United States v. Guerrier, 669 F.3d 1, 3 (1st Cir. 2011), we 

think dismissal was not called for. And so we reverse and remand 

for further proceedings. 

FFDCA Primer 

Here is what you need to know about the FFDCA (we 

simplify a bit). Enacted many decades ago "to protect consumers 

from dangerous products," see United States v. Sullivan, 332 U.S. 

689, 696 (1948), the FFDCA bans "[t]he introduction or delivery 

for introduction into interstate commerce of any . . . misbranded" 

prescription drug, see 21 U.S.C. § 331(a). A prescription drug is 

"misbranded" if it is "dispensed" without "a written prescription 

of a practitioner licensed by law to administer such drug." Id. 

§ 353(b)(1). "Dispensed" is an undefined FFDCA term, however. 

Anyhow, anyone who violates this law "with the intent to defraud 
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or mislead" commits a crime punishable with up to three years in 

prison. See id. § 333(a)(2). 

Case Background 

Shifting from the general to the specific, we believe a 

simple sketch of the key events suffices to put things in 

perspective. A quick heads up, though: because the judge 

dismissed the charges before trial, we describe the facts as though 

the government had proved what the indictment alleged, see United 

States v. Councilman, 418 F.3d 67, 71-72 (1st Cir. 2005) (en banc) 

— which of course is not the case. 

The Defendants 

Stepanets, Chin, and Thomas were Massachusetts-licensed 

pharmacists. That meant they could (among other things) dispense 

drugs, but only through "valid prescriptions from a medical 

practitioner."1 The trio worked as pharmacists for New England 

Compounding Center ("NECC" for short), a now-defunct 

Massachusetts-licensed pharmacy that specialized in "high-risk 

compounding" — a process that involves "using non-sterile 

ingredients to create sterile drugs." Assigned to NECC's "packing 

area," they "check[ed]" drug "orders" before "shipment to NECC's 

customers." 

 1 All quotations in this section come from the indictment 

unless otherwise noted. 
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The Indictment 

Eventually, Stepanets, Chin, and Thomas got swept up in 

a 131-count indictment that included 11 other persons with NECC 

ties. The gargantuan document catalogs an array of felonious 

conduct — for example, it alleges that NECC failed to follow proper 

sterilization procedures, opted to use expired or expiring 

ingredients, and neglected to run proper tests. As relevant for 

our purposes, the indictment alleges that our defendants dispensed 

drugs in violation of the FFDCA, specifically by causing misbranded 

drugs to be introduced into interstate commerce with the intent to 

defraud or mislead. And the indictment charges them both as 

principals and as aiders and abettors. See 18 U.S.C. § 2 (making 

aiders and abettors punishable as principals for the offenses they 

aided and abetted). 

The indictment is quite detailed — as a for-instance, 

the indictment identifies particular drug shipments to particular 

places on particular dates based on prescriptions for fake 

patients, and it specifies the laws the defendants allegedly broke. 

By way of illustration, just consider the following allegations 

pulled from the indictment: 

 on February 18, 2010, Stepanets caused 60 vials of 

"betamethasone repository" to be delivered to Lincoln, 
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Nebraska, based on prescriptions for "Wonder Woman" and "Fat 

Albert," among others;2

 similarly, on March 8, 2012, Chin caused 60 vials of 

"betamethasone repository" to be delivered to Lincoln, 

Nebraska, based on prescriptions for "Flash Gordon," "Tony 

Tiger," and "Chester Cheeto," among others; 

 and on March 20, 2012, Thomas and Stepanets caused 12 vials 

of "betamethasone repository" to be delivered to Elkhart, 

Indiana, based on prescriptions for "L.L. Bean," "Coco Puff," 

and "Filet O'fish," among others.3

 2 Betamethasone is a steroid medication "with antiinflammatory and immunosuppressive properties." See Baldwin v. 

White, No. 3:12CV210, 2013 WL 3893997, at *5 n.17 (E.D. Va. July 

26, 2013). 

3 For anyone not up on pop culture: Wonder Woman is a madeup superhero of comic book, television, and movie fame. Wonder 

Woman, Wikipedia, https://en.wikipedia.org/wiki/Wonder_Woman 

(last visited Jan. 3, 2018). So is Flash Gordon. Flash Gordon, 

https://en.wikipedia.org/wiki/Flash_Gordon (last visited Jan. 3, 

2018). Fat Albert is a cartoon character created by Bill Cosby. 

Fat Albert and the Cosby Kids, 

https://en.wikipedia.org/wiki/Fat_Albert_and_the_Cosby_Kids (last 

visited Jan. 3, 2018). Tony Tiger — a/k/a "Tony the Tiger" — is 

a cartoon spokesperson for Kellogg's Frosted Flakes cereal. Tony 

the Tiger, https://en.wikipedia.org/wiki/Tony_the_Tiger (last 

visited Jan. 3, 2018). Chester Cheeto — a/k/a "Chester Cheetah" 

— is a cartoon spokesperson for Frito Lay's Cheetos snacks. 

Chester Cheeto, https://en.wikipedia.org/wiki/Chester_Cheetah 

(last visited Jan. 3, 2018). L.L. Bean is a Maine-based outdoor 

clothing and equipment retailer. L.L. Bean, 

https://en.wikipedia.org/wiki/L.L.Bean (last visited Jan. 3, 

2018). Coco Puff — a variant spelling of "Cocoa Puffs" — is a 

chocolate-flavored cereal made by General Mills. Cocoa Puffs, 

https://en.wikipedia.org/wiki/Cocoa_Puffs (last visited Jan. 3, 
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Also, the indictment notes the statutory bases for the charges — 

21 U.S.C. §§ 353(b)(1), 331(a), and 333(a)(2), and 18 U.S.C. § 2 

— and mimics their language in key respects. 

The Dismissal Battles 

Responding to the indictment, Stepanets, Chin, and 

Thomas moved to dismiss the FFDCA charges against them — Stepanets 

filed her own motion, and Chin and Thomas filed a joint motion. 

Stepanets argued that she was not sufficiently involved in NECC's 

process to have "dispensed" the drugs and that the pertinent FFDCA 

provisions are unconstitutionally vague as applied to her. Chin 

and Thomas argued that the FFDCA does not require prescriptions to 

be "valid" for licensed pharmacists to fill them; that as a factual 

matter they were not personally responsible for taking the steps 

they deemed necessary for them to have "dispensed" the drugs; and 

that the parts of the FFDCA covering their conduct are 

impermissibly vague as applied to them. The government responded 

that the FFDCA does not allow licensed pharmacists to fill 

obviously fraudulent prescriptions; that the indictment's 

allegations — which must be taken as true — support the charges; 

 

2018). And Filet O'fish — a variant spelling of "Filet-O-Fish" — 

is a fish sandwich sold by McDonald's, a fast-food restaurant 

chain. Filet-O-Fish, https://en.wikipedia.org/wiki/Filet-O-Fish 

(last visited Jan. 3, 2018). 
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and that the FFDCA is sufficiently clear to withstand the 

defendants' vagueness challenges. 

Acting on the parties' submissions, the judge dismissed 

the FFDCA counts against the defendants. Stripped to essentials, 

the judge's reasoning went something like this: The indictment's 

allegations, the judge wrote, show that the defendants "knew or 

should have known that at least some of the shipping labels were 

made out in the names of fictitious patients." But, the judge 

added, that conclusion helped the government only so much. Relying 

on a medical dictionary's definition of "dispense," the judge ruled 

that "a pharmacist dispenses a drug when she acts in her role as 

a licensed professional to fill (put together) a medical 

prescription for delivery to a patient." From there, the judge 

said that the FFDCA "as written clearly punishes pharmacists who 

fill or take part in the filling of invalid prescriptions placed 

into interstate commerce with the intent to defraud or mislead the 

government." But he still thought the indictment did not provide 

"fair notice." Explaining why, the judge wrote that "conduct 

incidental to the distribution of prescribed drugs" — like 

"checking a package" — falls outside the FFDCA's reach, and he 

expressed his concern that "a reasonable pharmacist" would not 

know "from the indictment that by matching orders to packages prior 

to their being shipped, she was criminally liable for participating 
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in the filling of a prescription that she had never approved (or 

is even alleged to have seen)." 

Sticking to his views, the judge later denied the 

government's motion to reconsider. Two things about that ruling 

stand out. First, the judge read the indictment as simply accusing 

our defendants of committing a "clerical task" — a task, the judge 

added, that does not rise to the level of dispensing under the 

FFDCA. Second, responding to the government's argument that his 

earlier order did not address aiding-and-abetting liability, the 

judge said the indictment's allegations portrayed each defendant 

as "mere[ly] presen[t]" at the scene of the crime — and mere 

presence does not an aider and abettor make, the judge wrote, "even 

when coupled with knowledge that a crime is being committed by 

others." 

The Appeal Taken 

That brings us to today, with the government trying to 

torpedo the judge's rulings and the defendants trying to save them. 

Our jurisdiction secure thanks to 18 U.S.C. § 3731, we now offer 

our de novo take on the case. 

Analysis 

Guiding Legal Principles 

We begin with a few basics. The Constitution says that 

a criminal defendant cannot "be held to answer for a capital, or 
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otherwise infamous crime, unless on a presentment or indictment of 

a Grand Jury," U.S. Const. amend. V, and that she has "the right 

. . . to be informed of the nature and cause of the accusation," 

U.S. Const. amend. VI. Consistent with these commands, Federal 

Rule of Criminal Procedure 7(c)(1) says that an indictment must 

contain "a plain, concise, and definite written statement of the 

essential facts constituting the offense charged" — though an 

indictment's "count[s] may allege that the means by which the 

defendant committed the offense are unknown." An indictment need 

not say much to satisfy these requirements — it need only outline 

"the elements of the crime and the nature of the charge so that 

the defendant can prepare a defense and plead double jeopardy in 

any future prosecution for the same offense." See Guerrier, 669 

F.3d at 3. This means that an indictment that tracks a statute's 

terms is legally sufficient if the indictment itself gives the 

defendant adequate notice of the charges she must meet. See, e.g., 

Hamling v. United States, 418 U.S. 87, 117 (1974); United States 

v. Savarese, 686 F.3d 1, 6 (1st Cir. 2012); United States v. Troy, 

618 F.3d 27, 34 (1st Cir. 2010). 

As you read on, keep in mind as well that "[t]he 

government need not recite all of its evidence in the indictment." 

See United States v. Innamorati, 996 F.2d 456, 477 (1st Cir. 1993). 

Also keep in mind that courts must not inquire into the sufficiency 
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of the evidence underlying the indictment — for when "a defendant 

seeks dismissal of the indictment, the question is not whether the 

government has presented enough evidence to support the charge, 

but solely whether the allegations in the indictment are sufficient 

to apprise the defendant of the charged offense." See Savarese, 

686 F.3d at 7; see also Guerrier, 669 F.3d at 4 (noting that courts 

"routinely rebuff efforts to use a motion to dismiss as a way to 

test the sufficiency of the evidence behind an indictment's 

allegations"). Keep in mind too that in seeing whether an 

indictment is up to snuff, a court must reject arguments that 

embrace technical niceties at the expense of common sense. See 

United States v. Mubayyid, 658 F.3d 35, 69-70 (1st Cir. 2011); 1 

Charles Alan Wright & Andrew D. Leipold, Federal Practice and 

Procedure § 123 at 522-23 (4th ed. 2008). And definitely keep in 

mind that a court must deny a motion to dismiss if the motion 

relies on disputed facts. See, e.g., United States v. Covington, 

395 U.S. 57, 60 (1969) (holding that a court can resolve a pretrial 

motion to dismiss the indictment only when "trial of the facts 

surrounding the commission of the alleged offense would be of no 

assistance in determining the validity of the defense"); Fed. R. 

Crim. P. 12(b)(3) (noting that a motion to dismiss for failure to 

state a crime "must be raised by pretrial motion if the basis for 
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the motion is then reasonably available and the motion can be 

determined without a trial on the merits" (emphasis added)). 

A Sufficient Indictment 

Measured against these modest standards, the indictment 

here easily passes muster — just as the government argues. After 

all, and again: The indictment notes the statutory bases for the 

counts, listing the crimes' key elements. The indictment also 

provides the relevant factual backdrop, alleging for example that 

each defendant-pharmacist approved specified drug shipments, on 

specified dates, to specified locations, based on obviously 

invalid prescriptions for specified fake patients (e.g., "Wonder 

Woman" and "Coco Puff"). And the indictment connects the elements 

and the facts. So the indictment gives the defendants enough info 

to prepare a defense and to invoke double-jeopardy protections to 

forestall a later trial on the same charges. The law requires no 

more.4 See, e.g., Savarese, 686 F.3d at 6; Troy, 618 F.3d at 35. 

 4 The defendants scold the government for "[f]inding comfort 

in [the indictment's] tracking the language of the [FFDCA]." But 

we see nothing wrong with the government's approach, particularly 

since we have long held that "the statutory language may be used 

in the indictment to describe the offense," provided the indictment 

lets the defendant know the "general factual scenario on which the 

charges rest," see Troy, 618 F.3d at 34, 35 — a standard this 

indictment meets, for reasons already explained. 
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No Persuasive Counterarguments 

The reason why the judge's analysis veered off-track is 

because he made some out-of-place fact-assumptions — assumptions 

that devastate his conclusion about how the indictment 

insufficiently charges principal or aider-and-abettor liability. 

Unfazed, the defendants invite us to follow the judge's lead, 

advancing a number of counterarguments aimed at defending the 

judge's rulings. We decline the invitation — though before 

explaining why, we must first recap some things we said earlier. 

Recall that after focusing on the word "dispense" in the 

FFDCA, the judge ruled that the statute "punishes pharmacists who 

fill or take part in the filling of invalid prescriptions placed 

in interstate commerce."5 Moving on, the judge then read the 

 5 We take a quick timeout to straighten something out. Taking 

their cue from the judge below, the defendants say that 

Commonwealth v. Brown, 925 N.E.2d 845 (Mass. 2010), is — to quote 

their brief — "instructive in how to define 'dispense'" under the 

FFDCA. Dealing with Massachusetts's controlled-substances act — 

not with the FFDCA — Brown noted that the term "dispense" in the 

state statute is defined and limited to "deliver[y]" to the 

"ultimate user," and "ultimate user" is defined as someone who 

"lawfully possesses a controlled substance for his own use or the 

use of a member of his household." Id. at 855 (emphasis removed) 

(quoting Mass. Gen. Laws ch. 94C, § 1). So according to Brown, a 

drug is not "dispensed" under that statute if a person receives it 

because of "an invalid prescription" — though in that situation, 

because she "has devolved into a 'pusher,'" the physician can be 

prosecuted for "the crime of 'distribution.'" Id. at 857-58. 

Importantly for us, the FFDCA provisions in play here have no 

lawful-possession requirement. And given this big-time difference 

between the two statutes, there is no need to rely on Brown. 
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indictment as alleging that the defendants simply performed a 

"clerical task," like checking the address on a drug package's 

mailing label. And having done this, the judge concluded that the 

defendants could not have understood from the indictment that their 

conduct — helping fill prescriptions they never approved, much 

less saw — infracted the FFDCA. More, the judge also read the 

indictment as alleging that the defendants were merely present 

when the crimes occurred, which as he saw it sinks any aiding-andabetting theory. 

Recall too that the defendants — echoing the judge's 

analysis — claim as a factual matter that they acted not as NECC 

pharmacists but as NECC shipping clerks, performing "rotely 

clerical" tasks, like checking addresses on packages. They also 

insist that they did not "understand" from the FFDCA's language 

that they could be criminally liable for helping fill prescriptions 

they never signed off on, let alone caught sight of. And last but 

not least, they too assert that the indictment's allegations show 

only their mere presence at a crime scene, which in their telling 

means the document inadequately alleges aiding-and-abetting 

liability. 
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Taking first things first, we consider the indictment's 

allegations that the defendants participated as principals in the 

FFDCA crimes: 

We agree with the government that the major flaw in the 

judge's and the defendants' analyses is that the indictment says 

nothing — zippo — about the defendants' having simply checked 

addresses or worked as clerks. Rather, the indictments says that 

each of them (1) was "a pharmacist licensed . . . to dispense drugs 

pursuant to a valid prescription from a valid medical 

practitioner," (2) "was employed as a pharmacist at NECC," and 

(3) had caused misbranded drugs to be delivered into interstate 

commerce — allegations that hardly suggest that they labored at 

NECC as mere shipping clerks. Nor does the indictment say anything 

about how a non-pharmacist could do the jobs each defendantpharmacist did at NECC. 

Undaunted, the defendants note that the indictment 

alleges that each of them worked "in the packing area checking 

orders." And they insist — emphasis theirs — that "[i]t is 

undisputed that [their] role checking orders in the shipping 

department was limited to confirming that the correct drugs were 

being sent to the correct facility and did not include checking 

the prescriptions or patient names or any other aspect of the 

dispensing process." But the government does dispute that 
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contention, arguing for example that the "worked in the packing 

area checking orders" allegations — viewed in context and with 

common sense — connote the kind of checking that pharmacists 

regularly do when filling prescriptions, i.e., confirming that 

legit prescriptions triggered the drug shipments. Anyway, the 

defendants cite nothing in the indictment to support their theory 

that they did not check patient names or prescriptions.6 So at 

best for the defendants, we have disputes of fact — disputes that 

must be resolved at trial rather than on pretrial motions to 

dismiss. See Covington, 395 U.S. at 60; Guerrier, 669 F.3d at 3-

4. 

And what we have just said undermines the judge's and 

the defendants' no-fair-notice analyses as well. Even putting to 

 6 Interestingly, the defendants later admit that they did do 

more than check addresses, conceding in a footnote that NECC 

"use[d] a pharmacist . . . to check that the name and dosage of 

the drug on the shipping label [was] the same as the name and 

dosage on the order form." No big deal, they say, because NECC's 

use of a pharmacist was "a surfeit" and "hardly means that a nonpharmacist could not easily have performed the task." To their 

minds, "a pharmacist would only be required" — again, emphasis 

theirs — "if some sort of testing was performed," which "was not 

done, or alleged." This line of argument is full of holes, the 

most notable ones being: The defendants do not explain why they 

think NECC's use of a pharmacist was a surfeit (surfeit is 

basically a fancy word for excessive) — perhaps because the 

indictment does not allege non-pharmacists could have done what 

the defendants did. Also and critically, the indictment nowhere 

says that NECC needed pharmacists only when "some sort of testing" 

was required. 
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the side that no one cites a case — and we know of none — holding 

any key FFDCA provision void for vagueness,7 the no-fair-notice 

thesis depends on fact-assumptions about how the defendants did 

not know that they could be on the hook criminally for taking part 

in filling prescriptions they neither approved nor saw. But as 

the government notes, the indictment says nothing about the 

defendants' not approving or seeing the prescriptions. Properly 

understood then, the no-fair-notice theory depends on contested 

"facts surrounding the commission of the alleged offense" — facts 

no court may consider before trial. See Covington, 395 U.S. at 

60; see also Guerrier, 669 F.3d at 3. 

Turning then to the indictment's allegations that the 

defendants acted as aiders and abettors in the FFDCA crimes:8

Generally speaking, an aider and abettor is one who 

knowingly helps another commit a crime. See United States v. 

Urciuoli, 513 F.3d 290, 299 (1st Cir. 2008) (explaining that an 

 7 See generally United States v. Girod, No. 5:15-87-S-DCR, 

2017 WL 760742, at *1 (E.D. Ky. Feb 2, 2017) (stressing that "the 

courts have repeatedly upheld the constitutionality of the 

[FFDCA's] misbranding provisions . . . in the face of vagueness 

challenges"). 

8 We should first say that the defendants imply that the 

government cannot go the aiding-and-abetting route because it 

debuted that theory in a motion for reconsideration. But the judge 

did not reject the issue on lateness grounds, opting instead to 

address the issue head-on. So we consider the issue preserved for 

appellate review. See Trenkler v. United States, 536 F.3d 85, 96 

(1st Cir. 2008). 
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aider and abettor is one who "associate[s] himself with the 

venture, . . . participate[s] in it as in something that he wishes 

to bring about," and "seek[s] by his action to make it succeed" 

(quoting United States v. Peoni, 100 F.2d 401, 402 (2d Cir. 

1938))). In outlawing "aiding and abetting, Congress used language 

that 'comprehends all assistance rendered by words, acts, 

encouragement, support, or presence.'" Rosemond v. United States, 

134 S. Ct. 1240, 1246 (2014) (quoting Reves v. Ernst & Young, 507 

U.S. 170, 178 (1993)). 

As the government notes, the indictment specifically 

cites to the aiding-and-abetting statute, even though such a cite 

is not automatically required for the government to proceed on an 

aiding-and-abetting theory. See United States v. Sanchez, 917 

F.2d 607, 611 (1st Cir. 1990) (holding that "the government may 

rely on an 'aiding and abetting' theory, although the indictment 

neither alleges nor adverts to it, except on a showing of unfair 

surprise"). And despite what the judge thought and the defendants 

think, we believe a common-sense reading of the indictment's 

allegations suggests that each defendant-pharmacist performed 

NECC-assigned tasks that caused misbranded drugs to be introduced 

into interstate commerce — allegations that indicate that the 

defendants were not merely present, but were culpably present. 

See Urciuoli, 513 F.3d at 299. So once again, the defendants, 
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tracking the judge's line of reasoning, rely here on disputed facts 

that they want found in their favor — a situation that calls for 

a trial, not a dismissal on pretrial motions.9 See Covington, 395 

U.S. at 60; Guerrier, 669 F.3d at 3-4. 

Wrap Up 

Our work over, we reverse the judge's dismissal of the 

FFDCA charges against the defendants. 

 9 Two loose ends dangle. Focusing on the scienter element 

for aiding-and-abetting liability, the defendants suggest that the 

indictment does not allege that they knew the names on the 

prescriptions were phony. Even the judge below did not buy that 

argument, as he accepted for purposes of deciding the dismissal 

motions that the defendants had the requisite knowledge. And the 

defendants offer no persuasive basis for second-guessing the 

judge's reasoning. 

Without citing any authority, the defendants also suggest 

that we should affirm the judge's aiding-and-abetting ruling 

because the indictment (in their minds) fails to specifically 

identify who the principals were (if not these defendants, that 

is) — a ground not relied on by the judge. The suggestion is 

waived, however — they neglected to make it below; and if that 

were not enough, they neglected to adequately brief it here. See, 

e.g., Ayala-Sepúlveda v. Municipality of San Germán, 671 F.3d 24, 

30 n.4 (1st Cir. 2012); Muñiz v. Rovira, 373 F.3d 1, 8 (1st Cir. 

2004).