What Are Compounded Medications? Safety, Rules & How They Work

Compounded medications are prescription drugs made by a licensed pharmacy by combining or altering ingredients to create a medication that isn't commercially available, such as a different dose, form, or combination. They contain the same active ingredients as some FDA-approved drugs, but the finished products themselves aren't FDA-approved.

BlueChew offers compounded ED medications containing sildenafil, tadalafil, and vardenafil, the active ingredients in Viagra, Cialis, and Levitra, in sublingual tablets and combinations you can't get as a standard pill. Here's what compounding means, how it's regulated, and what it means for you.

• Compounded medications are custom-made by licensed pharmacies to meet needs that commercially available drugs don't, like a different form or a combination of ingredients.
• They aren't FDA-approved, and the FDA doesn't review them for safety, effectiveness, or manufacturing quality the way it reviews approved drugs.
• Compounding pharmacies are regulated by state boards of pharmacy and follow U.S. Pharmacopeia (USP) standards. Some larger facilities also register with the FDA.
• BlueChew's compounded formulas contain well-studied active ingredients. In clinical trials, 67–89% of men taking these PDE5 inhibitors had improved erections.
• A licensed provider reviews your health history before prescribing any compounded medication.

Compounding is when a licensed pharmacist combines, mixes, or alters ingredients to make a medication tailored to a patient's needs. Pharmacies have compounded medications for a long time. Common reasons include:

• A different form: a tablet that dissolves under the tongue instead of a pill you swallow
• A different dose: a strength that isn't commercially available
• A combination: two or more active ingredients in one dose
• Avoiding an ingredient: leaving out a dye, filler, or allergen

Compounding pharmacies are regulated mainly at the state level, with some federal oversight:

• State boards of pharmacy license compounding pharmacies, inspect them, and enforce state rules.
• U.S. Pharmacopeia (USP) standards set requirements for how medications are compounded, including USP <795> for non-sterile preparations like tablets and <797> for sterile ones.
• Federal law sets rules for compounding, including which bulk drug substances can be used. Traditional compounding pharmacies (called 503A pharmacies) compound for individual patients with a prescription, while larger outsourcing facilities (503B) register with the FDA and follow federal manufacturing standards.

Some pharmacies also earn accreditation showing they meet USP standards.

Compounded medications aren't generic versions of brand-name drugs. A generic is an FDA-approved copy of a brand-name drug. A compounded medication is a different product made to meet a need the approved version doesn't.

Compounded medications can be safe when they're prescribed by a licensed provider and made by a licensed pharmacy that follows USP standards and state rules. But because they aren't FDA-approved, the FDA hasn't verified their safety, effectiveness, or quality the way it does for approved drugs. That's why the pharmacy and the prescriber matter.

To use compounded medications safely:

• Get them by prescription from a licensed provider who reviews your health history.
• Use a licensed pharmacy. Avoid any website that sells "ED pills" without a prescription.
• Share every medication you take, especially nitrates, which can cause a dangerous drop in blood pressure with ED medications.
• Report side effects to your provider.

Like any prescription medication, compounded ED medications can cause side effects, most often headache, flushing, and nasal congestion.

BlueChew's formulas contain active ingredients from a class of drugs called PDE5 inhibitors, which increase blood flow to the penis during arousal. GOLD also adds apomorphine and oxytocin.

• SIL: sildenafil, the active ingredient in Viagra
• TAD: tadalafil, the active ingredient in Cialis
• VAR: vardenafil, the active ingredient in Levitra
• MAX: sildenafil + tadalafil
• VMAX: vardenafil + tadalafil
• GOLD: sildenafil, tadalafil, apomorphine, and oxytocin
• DailyTAD: tadalafil plus 7 essential vitamins, taken daily

All are sublingual tablets that dissolve under your tongue, except DailyTAD, which is chewable. Combinations like MAX, VMAX, and GOLD aren't available as standard FDA-approved pills, which is one reason they're compounded.

BlueChew's compounded medications haven't been studied themselves, but their active ingredients have decades of research behind them:

• In clinical trials, 67–89% of men taking PDE5 inhibitors had improved erections, compared with 27–35% on placebo.
• In a review of sildenafil trials, 78% of men reported improved erections, compared with 25% on placebo.
• In an analysis of tadalafil trials, 81% of men taking 20 mg reported improved erections.

That evidence is why many men find BlueChew works for them, though individual results vary.

Compounding lets BlueChew offer options you can't get from a standard pharmacy pill:

• Sublingual tablets: they dissolve under your tongue with no water and typically start working within 15–30 minutes. Here's how sublingual sildenafil compares to a pill.
• Combination formulas: MAX, VMAX, and GOLD pair a fast-acting ingredient with tadalafil's 36-hour window, and GOLD adds apomorphine and oxytocin to support arousal. See how GOLD compares to MAX and VMAX.
• Discreet packaging: each dose comes in a single-serving sachet that fits in your pocket.
• More choices: if one formula doesn't work for you, it's easy to switch.
• Lower cost: brand-name Viagra can cost $70 or more per pill, while BlueChew plans start at $30 a month.

BlueChew is a telehealth service, not a pharmacy. Licensed providers review your intake, and prescriptions are filled by licensed compounding pharmacies.

Interested in getting your hands on an erectile dysfunction prescription? BlueChew has got you covered.

Select a plan, complete an online intake, and you're done. A medical provider will review your information and, if appropriate, prescribe your plan, which will be shipped directly to your door.

No doctor appointments or patient support charges make it a stress-free experience.

Plus, there's no commitment—you can easily cancel or switch plans anytime. Click here to explore all plan options for treatments at BlueChew.

What are compounded medications?

Compounded medications are prescription drugs custom-made by a licensed pharmacy to meet a patient's needs, such as a different form, dose, or combination of ingredients than what's commercially available.

Are compounded medications FDA-approved?

No. Compounded medications aren't FDA-approved, and the FDA doesn't review them for safety, effectiveness, or manufacturing quality before they're dispensed. They're regulated by state boards of pharmacy and federal compounding rules, and pharmacies follow USP standards.

Are compounded medications safe?

They can be safe when prescribed by a licensed provider and made by a licensed pharmacy that follows USP standards. Because they aren't FDA-approved, choosing a reputable provider and pharmacy matters. Never take ED medication with nitrates.

Is a compounded medication the same as a generic?

No. A generic is an FDA-approved copy of a brand-name drug. A compounded medication is a different product made to meet a specific need, like a sublingual tablet or a combination of ingredients.

Do BlueChew's compounded medications work as well as Viagra and Cialis?

BlueChew's medications contain the same active ingredients as Viagra, Cialis, and Levitra, which are well studied and effective for most men. The compounded products themselves haven't been studied head-to-head against brand-name drugs, and individual results vary.

Why are BlueChew's medications compounded?

Compounding lets BlueChew offer sublingual tablets and combination formulas, like MAX, VMAX, and GOLD, that aren't available as standard FDA-approved pills.

Do I need a prescription for compounded medications?

Yes. A licensed provider reviews your online intake and prescribes a medication only if it's appropriate for you.