Recipient:
motionpharmacy.com

United States

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

FROM: The United States Food and Drug Administration

RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

DATE: September 10, 2025

WARNING LETTER

This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.motionpharmacy.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].

As discussed below, FDA has observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded opioids. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.

FDA has also observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines.

Additionally, FDA has observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants via the Internet poses additional significant risks to U.S. consumers.

Finally, FDA has observed that www.motionpharmacy.com introduces into interstate commerce unapproved and misbranded semaglutide drug products, including injectable versions. Injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.

There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.motionpharmacy.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.

Unapproved New Drugs:

Certain products offered for sale by www.motionpharmacy.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.

Examples of unapproved opioids you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:

Unapproved opioid: Marketed as: Evidence includes the claim(s):
hydrocodone bitartrate and acetaminophen “Hydrocodone”
“Vicodine (Hydrocodone)”
“Hydrocodone Bitartrate and Acetaminophen Tablets USP NDC 0591-0540-01”		 “Hydrocodone is a prescription medication at Motion Pharmacy classified as an opioid analgesic, primarily used to manage moderate to severe pain and to relieve coughing when combined with other medications.”
hydromorphone hydrochloride (HCl) “Dilaudid”
“Hydromorphone (Dilaudid)”
“® pms-HYDROmorphone 4 mg”
“® HYDROMORPH CONTIN® 4.5 mg”
“® HYDROMORPH CONTIN® 8 mg”
“® pms-HYDROmorphone 8 mg DIN 00885428”		 “Dilaudid is the brand name for hydromorphone, a powerful prescription opioid medication at Motion Pharmacy used to treat moderate to severe pain. It is often prescribed for patients who require relief from acute pain, such as post-surgical pain, or for chronic pain when other treatments are ineffective.”
oxycodone HCl “Oxycontin”
“Oxycontin (Oxycodone ER)”
“OxyContin® 10 mg prolonged release tablets”
“Oxycodone IR”
“Oxycodone Immediate Release”		 “OxyContin is a prescription opioid pain medication at Motion Pharmacy. It is an extended-release formulation designed to manage severe, ongoing pain that requires around-the-clock treatment. It works by altering how the brain and nervous system perceive pain.”
“Oxycodone IR (Immediate Release) at Motion Pharmacy is a potent prescription opioid medication used to relieve moderate to severe pain. It is a short-acting form of oxycodone, designed to provide quick relief from pain by releasing the active ingredient into the bloodstream rapidly.”
oxycodone HCl and acetaminophen “Percocets”
“DEPALGOS® 20 mg / 325 mg”		 “Percocet is commonly used to manage acute or chronic pain that cannot be controlled by non-opioid medications alone.”
oxymorphone HCl “Oxymorphone”
“Opana (Oxymorphone)”
“Opana® ER (oxymorphone hydrochloride) Extended-Release Tablets”		 “Oxymorphone is a powerful prescription opioid analgesic used for the treatment of moderate to severe pain.”
promethazine HCl “Promethazine”
“Promethazine Syrop”
“Promethazine Hydrochloride and Codeine Phosphate Oral Solution”
“Promethazine with Codeine Oral Solution”
“Wockhardt”
“Akorn”
“Tris”		 “Promethazine is an antihistamine commonly used for various medical purposes. It belongs to a class of drugs known as first-generation antihistamines, and it works by blocking the effects of histamine, a substance in the body involved in allergic reactions. It is often prescribed for allergy relief, but it has several other uses due to its sedative, anti-nausea, and anti-motion sickness properties.”

While there are FDA-approved versions of hydrocodone bitartrate and acetaminophen, hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), oxycodone HCl and acetaminophen (brand name PERCOCET), oxymorphone HCl, and promethazine HCl and codeine phosphate oral solution on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.motionpharmacy.com. Brand names VICODIN (hydrocodone bitartrate and acetaminophen), OPANA (oxymorphone HCl), and OPANA ER (oxymorphone HCl extended release) are discontinued.

FDA-approved hydrocodone bitartrate and acetaminophen, hydromorphone HCl (brand name DILAUDID), oxycodone HCl, and oxycodone HCl and acetaminophen (brand name PERCOCET) are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved oxycodone HCl extended release (brand name OXYCONTIN) is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved oxymorphone HCl is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved oxymorphone HCl extended release is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. FDA-approved promethazine HCl and codeine phosphate oral solution is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.

FDA-approved hydrocodone bitartrate and acetaminophen, hydromorphone HCl (brand name DILAUDID), oxycodone HCl (brand name OXYCONTIN), oxycodone HCl and acetaminophen (brand name PERCOCET), oxymorphone HCl, and promethazine HCl and codeine phosphate oral solution are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.

Examples of unapproved benzodiazepines you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:

Unapproved benzodiazepine: Marketed as: Evidence includes the claim(s):
clonazepam “Clonazepam”
“Rivotril (Clonazepam)”
“Rivotril® 2 mg tabletta clonazepam 30 db”
“Rivotril® tablet”		 “Rivotril is a brand name for the drug clonazepam, which is a benzodiazepine medication at Motion Pharmacy. It is primarily used to treat seizure disorders, anxiety disorders, and panic attacks. Rivotril works by calming the brain and nerves, which helps to reduce the frequency and severity of seizures and manage symptoms of anxiety.”
diazepam “Diazepam”
“Valium”
“Valium® 10 mg comprimidos”		 “Diazepam is a medication belonging to the benzodiazepine class, commonly prescribed to treat a range of conditions by calming the central nervous system (CNS). It works by enhancing the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that inhibits brain activity, resulting in a calming and relaxing effect.”
estazolam “Estazolam”
“Estazolam TZF”		 “Estazolam is a prescription medication belonging to the benzodiazepine class, commonly used to treat insomnia. It works by enhancing the effects of a neurotransmitter called gamma-aminobutyric acid (GABA) in the brain, which helps to produce a calming effect.”
lorazepam “Lorazepam”
“Ativan”
“Ativan® (Lorazepam) 2 mg”		 “Lorazepam enhances the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that calms the brain and nervous system. By increasing GABA activity, lorazepam reduces excessive nerve activity, leading to a calming effect”
bromazepam “Bromazepam”
“BROMAZÉPAM BIOGARAN® 6 mg”
“Bromazepam 6 – 1 A Pharma® 6 mg Tabletten”		 “Bromazepam is a prescription medication belonging to the benzodiazepine class. It is primarily used for the short-term treatment of anxiety disorders, including excessive worry, agitation, and tension.”
bromazolam “Bromazolam” “Bromazolam is a benzodiazepine medication that is chemically related to alprazolam (Xanax). It is primarily used for its anxiolytic (anxiety-reducing) and sedative properties. Bromazolam is not widely approved for medical use in many countries, but it has been available in some regions or online markets as a research chemical.”

While there are FDA-approved versions of clonazepam (brand name KLONOPIN), diazepam (brand name VALIUM), estazolam, and lorazepam (brand name ATIVAN) on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.motionpharmacy.com. Brand name PROSOM (estazolam) is discontinued. FDA-approved clonazepam (brand name KLONOPIN) is indicated for the treatment of certain seizure disorders and panic disorder with or without agoraphobia as defined in DSM-5. FDA-approved diazepam (brand name VALIUM) is indicated for anxiety disorders, acute alcohol withdrawal symptoms, skeletal muscle spasm relief, and as adjunctive therapy in convulsive disorders. FDA-approved estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. FDA-approved lorazepam (brand name ATIVAN) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. There are no FDA-approved versions of bromazepam nor bromazolam on the market in the U.S., and there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for bromazepam nor bromazolam offered by www.motionpharmacy.com.

FDA-approved clonazepam (brand name KLONOPIN), diazepam (brand name VALIUM), estazolam, and lorazepam (brand name ATIVAN) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Examples of unapproved Schedule II stimulants you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:

Unapproved Schedule II stimulant: Marketed as: Evidence includes the claim(s):
lisdexamfetamine dimesylate “Vyvanse”
“Lisdexamphetamine”
“Vyvanse® 50 mg Lisdexamfetamine dimesilate 50 mg”		 “Vyvanse (generic name: lisdexamfetamine dimesylate) is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adults and children aged six and older.”
methylphenidate HCl “Concerta”
“methylphenidate”
“methylphenidate hydrochloride”
“Concerta (Metilfenidato Clorhidrato) 36 mg”
“Concerta XL 36 mg PL 00432/0373”
“Ritalin”
“Ritalin® LA Methylphenidate hydrochloride AUST R 82958”

“Concerta is a prescription medication containing methylphenidate hydrochloride, a stimulant that affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.”

“Ritalin is a prescription medication at Motion Pharmacy is primarily used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, a sleep disorder. The active ingredient in Ritalin is methylphenidate, a stimulant that works by affecting certain chemicals in the brain that contribute to impulse control and hyperactivity.”

While there are FDA-approved versions of lisdexamfetamine dimesylate and methylphenidate HCl on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for these drug products offered by www.motionpharmacy.com. FDA-approved lisdexamfetamine dimesylate (brand name VYVANSE) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. FDA-approved methylphenidate HCl (brand name RITALIN) is indicated for the treatment of ADHD in pediatric patients 6 years and older and adults and narcolepsy. Using the brand name of the drug product RITALIN indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved methylphenidate HCl extended release is indicated for the treatment of ADHD, in pediatric patients 6 to 12 years of age (brand name RITALIN LA) and indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65 (brand name CONCERTA).

FDA-approved lisdexamfetamine dimesylate (brand name VYVANSE) and methylphenidate HCl (brand names RITALIN, RITALIN LA, and CONCERTA) are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved lisdexamfetamine dimesylate (brand name VYVANSE) and methylphenidate HCl (brand names RITALIN, RITALIN LA, and CONCERTA) each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, these drug products can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.

An example of unapproved semaglutide you offer for sale on www.motionpharmacy.com, including how this product is marketed on your website and evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128), is listed below:

Unapproved semaglutide: Marketed as: Evidence includes the claim(s):
semaglutide “Ozempic”
“OZEMPIC 1 mg”
“OZEMPIC® 1 mg Injektionslösung im Fertigpen Semaglutid Subkutane Anwendung”

“Increases insulin production: Helps regulate blood sugar after meals.”

“Reduces glucagon secretion: Lowers blood sugar levels by preventing excessive sugar release from the liver.”

While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for semaglutide offered by www.motionpharmacy.com. Currently there are three semaglutide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide tablets (brand name RYBELSUS) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide injection (brand name OZEMPIC) is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection (brand name WEGOVY) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide products also bear a boxed warning, which again, is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of thyroid C-cell tumors.

Misbranded Drugs:

A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if its labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription
drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.

Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. Consequently, the labeling for these drugs fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.motionpharmacy.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

FDA has also observed that the www.motionpharmacy.com offers prescription drugs for sale without a prescription. In addition to the aforementioned drugs, examples of misbranded opioids you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:

Misbranded opioid: Marketed as: Evidence includes the claim(s):
buprenorphine HCl “Buprenorphine”
“Buprenorphine Sublingual Tablets NDC 0054-0177-13”		 “Buprenorphine is a prescription medication used primarily for the treatment of opioid use disorder (OUD) and for managing moderate to severe pain. It is classified as a partial opioid agonist, meaning it activates opioid receptors in the brain to a lesser extent than full agonists like heroin or oxycodone.”
buprenorphine HCl and naloxone HCl “Suboxone”
“Suboxone (Buprenorphine and Naloxone)”
“Suboxone® (buprenorphine and naloxone) sublingual film 8 mg/2 mg NDC 12496-1208-3”		 “Suboxone is a prescription medication used in the treatment of opioid dependence and addiction. It is a combination of two active ingredients: buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. Together, these ingredients help reduce withdrawal symptoms and cravings while discouraging misuse.”
morphine sulfate “Morphine
“Morphine Sulphate
“Morphine Sulphate Oral Solution NDC 0406-8003-30”
“Morphine Sulphate Extended-Release Capsule NDC 0228-3090-11”		 “Morphine sulfate is a powerful opioid medication commonly prescribed to manage moderate to severe pain. It belongs to a class of drugs called opioid analgesics, which work by binding to opioid receptors in the brain and spinal cord.”

FDA-approved buprenorphine HCl is indicated for the treatment of opioid dependence and is preferred for induction. FDA-approved buprenorphine HCl and naloxone HCl (brand name SUBOXONE) is indicated for treatment of opioid dependence. Both drug products are indicated to be used as part of a complete treatment plan to include counseling and psychosocial support. FDA-approved morphine sulfate is indicated for the management of acute or chronic pain severe enough to require an opioid analgesic. FDA-approved morphine sulfate extended release is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic. Both drug products are indicated for which alternative treatment options are inadequate.

FDA-approved buprenorphine HCl, buprenorphine HCl and naloxone HCl (brand name SUBOXONE), and morphine sulfate are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved buprenorphine HCl, buprenorphine HCl and naloxone HCl (brand name SUBOXONE), and morphine sulfate each bear a boxed warning addressing risks including addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and accidental exposure resulting in death. In addition, when these drug products are taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.

An example of a misbranded benzodiazepine you offer for sale on www.motionpharmacy.com, including how this product is marketed on your website and evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128), is listed below:

Misbranded benzodiazepine: Marketed as: Evidence includes the claim(s):
alprazolam “Alprazolam”
“Xanax”
“alprazolam tablets, USP 1 mg NDC 59762-3721-1”
“alprazolam XR, extended-release tablets, 3 mg NDC 59762-0068-1”
“Alprazolam Tablets, USP 2 mg NDC 51991-707-05”		 “Xanax is a brand name for alprazolam, a medication in the benzodiazepine class. It is used primarily to treat anxiety disorders, including generalized anxiety disorder (GAD) and panic disorder. Alprazolam works by enhancing the effects of gamma-aminobutyric acid (GABA), a neurotransmitter that reduces brain activity and has a calming effect on the nervous system.”

FDA-approved alprazolam (brand name XANAX) is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia. FDA-approved alprazolam (brand name XANAX) is only available pursuant to a prescription from a licensed practitioner. Furthermore, this drug product bears a boxed warning addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Examples of misbranded Schedule II stimulants you offer for sale on www.motionpharmacy.com, including how these products are marketed on your website and evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128), are listed below:

Misbranded Schedule II stimulant: Marketed as: Evidence includes the claim(s):
amphetamine “Adderall”
“Adderall (Dextroamphetamine/amphetamine)”
“ADDERALL XR® NDC 54092-383-01”		 “Adderall is a prescription medication at Motion Pharmacy that contains a combination of two stimulant drugs: amphetamine and dextroamphetamine. It is primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy (a sleep disorder).”
dextroamphetamine sulfate “Dextroamphetamine”
“Dextroamphetamine Sulphate”
“Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets NDC 0555-0973-02”
“Dextroamphetamine Sulphate Tablets, USP NDC 52536-500-03”		 “Dextroamphetamine sulfate is a stimulant medication commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.”
“Dextroamphetamine sulfate works by increasing the levels of certain chemicals (neurotransmitters) in the brain, particularly dopamine and norepinephrine, which help improve focus, attention, and impulse control in people with ADHD.”

FDA-approved amphetamine (brand name ADDERALL) is indicated for the treatment of ADHD and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved amphetamine extended release (brand name ADDERALL XR) is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. FDA-approved dextroamphetamine sulfate is indicated for narcolepsy and ADHD in patients ages 3 to 16 years.

FDA-approved amphetamine (brand name ADDERALL), amphetamine extended release (brand name ADDERALL XR), and dextroamphetamine sulfate are only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved amphetamine (brand name ADDERALL), amphetamine extended release (brand name ADDERALL XR), and dextroamphetamine sulfate each bear a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, these drug products can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.

Under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.motionpharmacy.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].

FDA is sending this warning letter to www.motionpharmacy.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act.

Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.

If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.

Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.

Sincerely,
/S/

Sangeeta Vaswani Chatterjee, Pharm.D.  
Acting Director  
Office of Drug Security, Integrity, and Response  
Office of Compliance  
Center for Drug Evaluation and Research