Any preparation that is legal to compound in the United States. Our 503B facilities make the sterile injectables: vials, prefilled syringes, premixed bags and pellets. Our 503A pharmacies make the tablets, capsules, chews, troches, creams and drops. Everything ships only to licensed prescribers, clinics, pharmacies and medical groups. We negotiate the contract, help you reformulate, and keep the supply running, with some of the largest facilities in the United States.
Your supply agreement
503B outsourcing facility · office stock
- Testosterone cypionate 200 mg/mL10 mL vials · cGMP lot with CoA
- NAD+ 100 mg/mL5 mL vials · cold chain
- Lidocaine / tetracaine numbing cream30 g jars · case minimum 12
- Net-30 terms, price locked 90 days
Patient prescription
503A pharmacy · shipped to the patient
- Estradiol / progesterone cream
- Low-dose naltrexone 4.5 mg
- Tretinoin 0.05% / niacinamide 4%
- Refill in 28 days
A 503A pharmacy is a traditional compounding pharmacy. The name comes from Section 503A of the Federal Food, Drug, and Cosmetic Act, which sets the conditions under which a licensed pharmacist (or a physician) can prepare a medication for one specific patient without that preparation going through FDA approval.
The defining rule is the prescription. A 503A pharmacy compounds a preparation only after it receives a valid prescription for a named patient, or in limited quantities in anticipation of prescriptions it regularly fills. It cannot keep stock on hand to sell to clinics for in-office use, even in states whose own laws allow it, because federal law does not provide for office-use supply under 503A.
Oversight sits mainly with the state board of pharmacy, with FDA stepping in for specific federal provisions. Quality is governed by the United States Pharmacopeia chapters on non-sterile compounding (<795>), sterile compounding (<797>) and hazardous drugs (<800>). Ingredients must meet a USP or NF monograph, be a component of an FDA-approved drug, or appear on FDA's 503A bulk-substances list.
A 503A pharmacy may not compound a preparation that is essentially a copy of a commercially available FDA-approved drug, unless the prescriber documents a change that makes a significant clinical difference for that patient, such as a different strength, an allergen removed, or a different dosage form. It also cannot compound drugs FDA has withdrawn for safety reasons, and its ability to ship across state lines is limited under FDA's memorandum-of-understanding rules.
- A valid prescription for a named patient, every time
- Regulated mainly by the state board of pharmacy
- USP <795>, <797> and <800> standards
- Custom strengths, dosage forms, flavors, and allergen-free or preservative-free versions
- Best for hormone therapy, dermatology, pediatrics, veterinary care, hospice and anything that needs personalizing
A 503B outsourcing facility is a compounder that has registered with FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act. Congress created the category in the Drug Quality and Security Act of 2013, after a 2012 outbreak of fungal meningitis traced to contaminated sterile injections from a compounding pharmacy.
The defining feature is scale without a prescription. A 503B facility can compound in large batches and sell to hospitals, surgery centers, clinics, med spas and physician offices for office use, with no patient named in advance. It can also fill patient-specific prescriptions. In return it is held to a manufacturer-style standard: current good manufacturing practice (cGMP), FDA inspections, annual registration and fees, product reports to FDA twice a year, and adverse-event reporting.
Every lot is compounded by or under the direct supervision of a licensed pharmacist, released with testing (potency, sterility and endotoxin for injectables), and labeled with the facility's name, the lot number, a beyond-use date and the words “This is a compounded drug.” Bulk ingredients can only be used if they appear on FDA's 503B bulk-substances list or the drug is on FDA's shortage list, and the facility cannot compound a product that is essentially a copy of an approved drug unless that drug is in shortage.
The result is a reliable, inspected supply of ready-to-use vials, prefilled syringes, premixed bags, creams and kits that a practice can keep on the shelf, at a per-unit cost that drops with volume.
- Registered with FDA and inspected to cGMP
- Sells office stock to licensed practices and hospitals with no patient-specific prescription
- Tested, lot-numbered products with a certificate of analysis
- Large batches, multi-state distribution and standing orders
- Best for injectables, prefilled syringes, premixed IVs, numbing creams and any product you use on site every day
| 503A compounding pharmacy | 503B outsourcing facility | |
|---|---|---|
| Prescription required | Yes, for a named patient | No, office stock is allowed |
| Who oversees it | State board of pharmacy, with specific federal provisions | FDA registration and inspections, plus state licensing |
| Quality standard | USP <795>, <797>, <800> | Current good manufacturing practice (cGMP) |
| Sells to clinics for in-office use | — | |
| Ships to patients directly | Through a prescription, where licensed | |
| Ships across state lines | Limited | Yes, to licensed sites in states where it holds a license |
| Batch size | One prescription at a time, plus limited anticipatory batches | Large validated batches |
| Lot testing and certificate of analysis | Per state rules, often not required | |
| Custom formulation per patient | Standardized products only | |
| Price per unit | Higher | Lower, falls with volume |
| Minimum order | None | Often a case minimum per product |
| Typical lead time | 1–5 days per prescription | Stocked items ship in days; new products take weeks |
| Best for | Personalized therapy and patient shipping | Everything you use on site, in volume |
If it is legal to compound in the United States, one of our partners makes it, and it ships only to licensed accounts.
From our partner formularies: the same compounded programs the national telehealth brands run, in weight management, hormones, testosterone, hair, skin and sexual health, plus the specialty work clinics and hospitals need. If it is on this list, we have a licensed facility under contract that makes it.
Partner formulary · examples
| Category | Example preparations | 503A | 503B |
|---|---|---|---|
| Hormone therapy | Estradiol, estriol (Biest), progesterone, testosterone, DHEA, pregnenolone in creams, capsules, troches and pellets | Yes | Pellets, vials |
| Men's health and TRT | Testosterone cypionate and enanthate vials, gonadorelin, anastrozole and clomiphene low-dose capsules | Per patient | Office stock |
| Weight management | Semaglutide and tirzepatide vials and troches, lipotropic (MIC) and B12 injections, low-dose naltrexone | Yes | Office stock |
| IV and injectable nutrients | Vitamin C, B-complex, B12, magnesium, zinc, glutathione, amino-acid blends, Myers'-style components | Per patient | Office stock |
| Longevity | NAD+ injections and nasal sprays, methylene blue, glutathione, low-dose sirolimus capsules | Yes | Vials |
| Women's health | Vaginal estriol and DHEA, testosterone cream for women, progesterone for perimenopause, oxytocin, custom libido preparations | Yes | Rare |
| Sexual health | Sildenafil and tadalafil troches and ODTs, Trimix / Bimix / Quadmix injections, oxytocin, vaginal DHEA and estriol | Yes | Trimix vials |
| Dermatology | Tretinoin combinations, hydroquinone blends for melasma, azelaic acid, topical spironolactone, oral and topical tranexamic acid | Yes | Select creams |
| Aesthetics | Lidocaine / tetracaine (BLT) numbing creams, buffered lidocaine with epinephrine, hyaluronidase, tranexamic acid injections | Per patient | Office stock |
| Hair restoration | Topical minoxidil with finasteride or dutasteride, low-dose oral minoxidil, latanoprost and ketoconazole topicals | Yes | Rare |
| Pain management | Ketamine, gabapentin, lidocaine, diclofenac and baclofen topical blends, ketamine troches, ketorolac and trigger-point injections | Yes | Syringes, vials |
| Ketamine and infusion clinics | Ketamine vials and prefilled syringes, ondansetron, midazolam, premixed infusion bags | Per patient | Office stock |
| Ophthalmology | Atropine 0.01% for myopia, autologous serum tears, fortified antibiotics, repackaged bevacizumab syringes, intracameral moxifloxacin, dilating combinations | Drops | Syringes, drops |
| Hospital and surgery center | Prefilled syringes (phenylephrine, ephedrine, succinylcholine, rocuronium, opioids), premixed norepinephrine and oxytocin bags, epidural mixes, cardioplegia, pediatric dilutions | Rare | Core business |
| Pediatrics | Flavored suspensions, dye-free and allergen-free versions, dose conversions of tablets into liquids, propranolol and omeprazole suspensions | Yes | Dilutions |
| Dental | Profound-style topical anesthetics, triple antibiotic paste, dry-socket paste, chlorhexidine and fluoride preparations | Yes | Numbing gels |
| Veterinary | Species-specific doses, transdermal methimazole for cats, flavored chews, gabapentin and other suspensions | Yes | Clinic stock |
| Hospice and palliative | ABH gel (lorazepam / diphenhydramine / haloperidol), concentrated oral solutions, suppositories | Yes | Rare |
| Allergy | Sublingual allergen drops and custom immunotherapy preparations | Yes | Rare |
| Thyroid and adrenal | Slow-release T3 and T4, T3/T4 combinations, hydrocortisone and melatonin in custom strengths | Yes | Rare |
A 503A preparation exists because an approved drug doesn't fit the patient: wrong strength, wrong form, an allergen, a flavor a child won't take, or a combination that saves four separate prescriptions.
Bioidentical hormone therapy
Estradiol, estriol and progesterone as creams, gels, capsules, troches and vaginal preparations, with strengths set from the patient's labs rather than the two or three commercial doses. Testosterone creams for women. DHEA, pregnenolone and melatonin in doses the market doesn't sell.
Men's health
Testosterone creams and gels, gonadorelin to support natural production during therapy, low-dose anastrozole and clomiphene capsules, and sildenafil or tadalafil as troches and orally dissolving tablets for patients who can't take or can't afford the tablets.
Weight management
Semaglutide and tirzepatide compounded for the patient, low-dose naltrexone capsules, lipotropic and B12 injections, and complete GLP-1 programs for telehealth brands and weight-loss clinics.
Dermatology and melasma
Tretinoin blended with clindamycin, niacinamide or azelaic acid in one cream. Hydroquinone, tretinoin and a mild steroid combined for melasma. Topical spironolactone for hormonal acne, topical tranexamic acid, and preservative-free versions for reactive skin.
Hair restoration
Topical minoxidil with finasteride or dutasteride so the patient uses one bottle, low-dose oral minoxidil capsules, latanoprost and ketoconazole topicals, and vehicle choices (foam, solution, cream) that patients actually keep using.
Pain and neuropathy
Topical blends of ketamine, gabapentin, lidocaine, diclofenac, baclofen and cyclobenzaprine that put the drug at the site instead of through the stomach. Ketamine troches and nasal sprays. Low-dose naltrexone for chronic pain and autoimmune conditions.
Longevity and energy
NAD+ as subcutaneous injections or nasal spray, methylene blue capsules and troches, glutathione, and low-dose sirolimus capsules, each at a strength written for the patient.
Ophthalmic
Atropine 0.01% drops for childhood myopia, autologous serum tears made from the patient's own blood, fortified antibiotic drops for corneal infections, higher-strength cyclosporine and preservative-free formulas.
Pediatrics
Tablets turned into flavored liquids at a child's exact dose, dye-free and gluten-free versions for allergies, propranolol suspensions for hemangiomas, omeprazole suspensions, and suppositories when a child can't swallow.
Dental
Profound-style topical anesthetic gels, triple antibiotic pastes for root canals, dry-socket pastes, high-strength chlorhexidine and fluoride, and mouth rinses for oral lesions.
Veterinary
Transdermal methimazole for cats, flavored chews and suspensions dosed by weight, apomorphine, gabapentin and other drugs that don't exist in an animal-sized form.
Hospice, allergy and thyroid
ABH gel for nausea and agitation, concentrated oral morphine, suppositories, sublingual allergen immunotherapy drops, slow-release T3, T3/T4 combinations and hydrocortisone at adrenal-support doses.
A 503B product exists because a practice uses it every day and needs it tested, labeled, shelf-stable and on hand before the patient walks in.
Testosterone and men's health vials
Testosterone cypionate and enanthate in multi-dose vials, often in grapeseed or cottonseed oil, with gonadorelin and Trimix / Bimix / Quadmix vials for erectile dysfunction, shipped as office stock to TRT clinics and men's health brands.
Injectable nutrients
B12 (methylcobalamin and cyanocobalamin), lipotropic MIC blends, biotin, glutathione, NAD+, vitamin C, B-complex, magnesium, zinc and amino-acid blends in vials and prefilled syringes for weight-loss, IV and wellness clinics.
IV therapy components and premixes
High-dose vitamin C, Myers'-style components, ondansetron and ketorolac syringes, premixed hydration add-ins and amino-acid bags for IV lounges and mobile IV companies.
Aesthetic practice supplies
Lidocaine / tetracaine and benzocaine / lidocaine / tetracaine (BLT) numbing creams in strengths up to 23/7, buffered lidocaine with epinephrine, hyaluronidase vials for filler correction, tranexamic acid injections and solutions.
Ketamine and infusion clinics
Ketamine in vials and prefilled syringes at clinic concentrations, midazolam, ondansetron and premixed infusion bags, with the cGMP paperwork an infusion clinic needs for its own accreditation.
Hormone pellets and GLP-1 vials
Testosterone and estradiol pellets for insertion in the office, and semaglutide and tirzepatide in multi-dose vials for weight-loss clinics and telehealth programs, shipped as office stock with lot testing.
Ophthalmology
Repackaged bevacizumab syringes for retina practices, intracameral moxifloxacin and antibiotic-steroid combinations for cataract surgery, dilating drop combinations, mitomycin C and lidocaine gels.
Hospital and surgery center syringes
Prefilled phenylephrine, ephedrine, succinylcholine, rocuronium, fentanyl, hydromorphone and midazolam syringes for the operating room, oxytocin and norepinephrine premixed bags, epidural mixes, cardioplegia solutions and pediatric dilutions.
Drug-shortage substitutes
When an approved injectable goes on FDA's shortage list, a 503B facility can compound it so hospitals and clinics keep operating. Facilities with shortage programs are the ones to have under contract before you need them.
Pain and procedure kits
Ketorolac, dexamethasone and lidocaine or bupivacaine syringes for trigger points and joint injections, dextrose solutions for prolotherapy, and procedure kits packed for a specific workflow.
Dental and dermatology stock
Topical anesthetic gels and numbing creams by the case, tranexamic acid, and select dermatology creams in standardized strengths for practices that dispense on site.
Veterinary clinic stock
Office-use injectables and suspensions for veterinary hospitals, under FDA's animal-drug compounding guidance, with the same lot testing and labeling as human products.
What you can ask for once a contract is in place.
503A compounding pharmacy
- Custom strength and dose for a single patient
- Dosage-form changes: capsule to liquid, troche, orally dissolving tablet, cream, gel, suppository, nasal spray or patch
- Several active ingredients combined into one preparation
- Flavoring for children and animals
- Dye-free, gluten-free, lactose-free, preservative-free and sugar-free versions
- Preparations of drugs that are discontinued, back-ordered or never sold in that form
- Patient-specific sterile injectables, eye drops and inhalations under USP <797>
- Hazardous-drug compounding under USP <800>
- Prescriber consultations on strength, vehicle and compatibility
- Direct shipping to the patient in states where the pharmacy is licensed
- Telehealth prescription routing and electronic prescribing
- Refill reminders, adherence packaging and patient counseling
503B outsourcing facility
- Office-use stock with no patient-specific prescription
- Large-batch sterile injectables in multi-dose and single-dose vials
- Prefilled, labeled syringes ready to administer
- Premixed IV bags and infusion add-ins
- Repackaging of approved drugs into ready-to-use units
- Stability-tested beyond-use dates, often months rather than days
- A certificate of analysis with every lot: potency, sterility and endotoxin
- cGMP documentation for your accreditation and audits
- Cold-chain shipping and temperature logs
- Standing orders and automatic replenishment
- Distribution to every licensed site across the states where the facility holds a license
- Shortage substitutes when an approved drug is on FDA's list
Discovery
What you prescribe or administer, which states you operate in, your monthly volumes, and whether you need patient shipping, office stock or both.
Match
We shortlist facilities that are licensed in your states, already make what you need, and have capacity. Usually one 503B for stock and one 503A for patient prescriptions.
Reformulation
We work with the facility's pharmacists on strengths, vehicles and combinations that patients tolerate, that fit your protocols, and that stay inside the copy rules.
Contract
Pricing tiers by volume, case minimums, lead times, shipping, returns, a price-lock period, shortage clauses and payment terms. We negotiate all of it and you sign with the facility directly.
Onboarding
Account setup, prescriber credentialing, state license and DEA verification, ordering portal access, and routing from your EMR or telehealth platform.
Supply watch
We track FDA's bulk-substance and shortage lists, re-price at each lock period, and keep a second facility ready so one backorder never stops your clinic.
Facilities sell to thousands of accounts. We make sure yours gets the pricing, the attention and the paperwork of a large one.
Med spas and aesthetics
Numbing creams, hyaluronidase, tranexamic acid, nutrient injections and hormone pellets as office stock.
Weight-loss and wellness clinics
GLP-1 vials, injectable nutrients, lipotropics and NAD+.
TRT and men's health
Testosterone vials, gonadorelin, Trimix and sexual-health troches.
Hormone and longevity clinics
Bioidentical hormones, pellets, thyroid, NAD+ and methylene blue.
Ketamine and IV clinics
Ketamine syringes, premixed bags and the cGMP paperwork for accreditation.
Hospitals and surgery centers
Prefilled OR syringes, premixed bags and shortage substitutes from facilities built for hospital volume.
Ophthalmology, dental and veterinary
Specialty preparations that no manufacturer makes in the form you use.
