FAQs

A compounding pharmacy becomes necessary when a patient's specific medical needs cannot be met by standard, mass-produced medications. At SolLabs, we work with your physician to create a custom solution when a commercial drug is not appropriate for you.
You may need our services if you:

• Require a Custom Strength: Your treatment requires a dosage that isn't commercially available, such as a very small dose for a child or a specific strength for hormone therapy.

• Have Allergies or Sensitivities: You're allergic to common inactive ingredients like gluten, lactose, or dyes found in many pills. We can formulate your medication without these additives.

• Cannot Use the Standard Form: You have difficulty swallowing pills. We can change the medication's form into a liquid, topical cream, lozenge, or other form that works for you.
  Need a Discontinued Medication: A drug you rely on is no longer being manufactured by pharmaceutical companies. We can often source the active ingredients to recreate it for you.

• Would Benefit from Flavoring: The taste of a medication makes it difficult to take. We can add a variety of flavors to improve palatability, which is especially helpful for children.

A wide range of medical specialties rely on compounded medications to provide personalized patient care. Compounding pharmacies collaborate with prescribers across numerous fields when a one-size-fits-all approach isn't suitable. Virtually any specialty can use compounded medications, but some of the most common fields include:

• Dermatology

• Pain Management

• Hormone Replacement Therapy (HRT)

• Pediatrics

• Veterinary Medicine

• Podiatry

• Dentistry

• Urology

A sterile compound is a customized medication that is prepared in a completely sterile, contaminant-free environment. These medications are required for routes of administration that bypass the body’s natural defenses, such as the skin or digestive tract. At SolLabs, we prepare sterile compounds such as vials for injections for hormone treatments, urology treatments, and vitamins.

The primary benefit of a compounding pharmacy is access to personalized medication solutions that are specifically designed to meet your individual needs. At SolLabs, we go beyond the limitations of mass-produced drugs to solve medication-related problems for you and your doctor. The key benefits of choosing a compounding pharmacy like SolLabs include:

• Tailored Dosage Strengths: We can create a medication in the exact dosage your doctor prescribes, which is ideal if you need a strength that isn't commercially available. This is crucial for many therapies, including hormone replacement, pediatric care, and pain management.

• Allergen-Free Formulations: If you have an allergy or sensitivity to common inactive ingredients like gluten, lactose, preservatives, or dyes, we can create a version of your medication without the problematic ingredient.

• Alternative Medication Forms: For patients who have difficulty swallowing pills or need medication applied to a specific area, we can change the form of a drug. We can convert a pill into a flavored liquid, a topical cream or gel, a lozenge, or a suppository to improve ease of use and effectiveness.

• Recreating Discontinued Medications: When a pharmaceutical company stops manufacturing a drug you rely on, our lab can often recreate it for you with a valid prescription, ensuring continuity of care.

• Simplified Dosing: If you take multiple medications, we can sometimes combine several compatible active ingredients into a single capsule or cream. This simplifies your daily routine and can improve adherence to your treatment plan.

Yes, compounded medications are safe when they are prescribed by a licensed physician and prepared by a reputable, licensed compounding pharmacy like SolLabs that follows all required safety and quality standards.
It's important to understand how compounded drugs are regulated to ensure their safety:

• FDA Status: Compounded medications are not FDA-approved. The FDA approval process is designed for mass-produced drugs, not for unique medications made for individual patients. Because we create a specific formula for one person, it does not go through the FDA's large-scale clinical trials.

• Quality Standards and Regulation: While not FDA-approved, compounded medications are highly regulated. At SolLabs, we are governed by our State Board of Pharmacy and adhere strictly to the standards set by the United States Pharmacopeia (USP). These standards dictate the procedures, ingredients, and environment required for safe compounding:

  • USP <795>: Sets the national standard for preparing non-sterile compounds (like creams, capsules, and liquids).

  • USP <797>: Sets the strict national standard for sterile compounding (like injections and eye drops) to prevent contamination and ensure patient safety.

• Our Commitment to Safety: Your safety is our highest priority at SolLabs. We ensure this by:

  • Using only high-quality active pharmaceutical ingredients (APIs) from FDA-registered suppliers.

  • Employing licensed pharmacists and technicians with specialized training in compounding.

  • Preparing all sterile medications in a state-of-the-art cleanroom to prevent contamination.

  • Following rigorous documentation and quality assurance protocols for every prescription we fill.

The safety of your medication relies on the partnership between your doctor, who prescribes the appropriate formula, and a qualified compounding pharmacy that prepares it correctly. We are dedicated to being a trusted partner in your healthcare.

No, compounded drugs are not FDA-approved. This is a key distinction, and the reason is central to why compounding pharmacies like SolLabs exist. The FDA approval process is designed for mass-produced drugs intended to be marketed to the general public. This process involves large-scale, expensive, and lengthy clinical trials to prove safety and efficacy for a broad population. Compounded medications, by definition, are created for a single, specific patient based on a unique prescription from their doctor. It would be impractical to conduct a full FDA trial for a medication made for just one person.
However, "not FDA-approved" does not mean "unregulated." Your safety is ensured through a different, robust system of oversight:

• State Boards of Pharmacy: Compounding pharmacies are licensed and regulated by their respective State Boards of Pharmacy, which provide primary oversight of our practice.

• USP Standards: We are legally required to adhere to strict quality and safety standards set by the United States Pharmacopeia (USP), including USP Chapter <795> for non-sterile and USP Chapter <797> for sterile medications.

• FDA-Registered Ingredients: While the final product isn't approved, we use active pharmaceutical ingredients (APIs) that are sourced from FDA-registered suppliers.
  

In short, the regulatory framework for compounding focuses on the process, environment, and ingredients to ensure a safe, customized medication is produced for a specific patient, whereas FDA approval focuses on the final, mass-marketed product.

The primary differences between 503A and 503B compounding pharmacies relate to prescription requirements, regulatory oversight, and the scale of production.
503A Compounding Pharmacies (Like SolLabs):

• Patient-Specific Prescriptions: Our primary function is to prepare a unique medication based on a valid prescription for an identified, individual patient. We create a medication specifically for you.

• Scale: We compound in small batches tailored to individual patient needs. We are permitted to engage in limited "anticipatory compounding" based on a history of filling certain prescriptions, but the medication can only be dispensed once we receive your prescription.

• Regulatory Oversight: We are licensed by and primarily regulated by our State Board of Pharmacy. We must comply with state regulations and the quality standards set by the United States Pharmacopeia (USP), specifically USP <795> for non-sterile and <797> for sterile compounds.

503B Outsourcing Facilities

• Bulk Production: 503B facilities are often called "outsourcing facilities." They are permitted to manufacture large batches of sterile and non-sterile medications with or without prescriptions. These products are typically sold to hospitals, clinics, and doctor's offices for "office use."

• Scale: They operate on a much larger, industrial scale, similar to a traditional pharmaceutical manufacturer.
  Regulatory Oversight: 503B facilities must register with the FDA and are subject to direct federal oversight. They must adhere to a more rigorous set of quality standards known as Current Good Manufacturing Practices (cGMP), the same standards that large drug manufacturers must follow.

You would use a 503A pharmacy like SolLabs for a medication that is personally prescribed by your doctor and created just for you. A hospital or clinic would use a 503B facility to purchase compounded drugs in bulk to have on hand for administration to their patients.

Yes, pharmaceutical compounding is fundamentally different from drug manufacturing. While both result in a medication, they are distinct in their purpose, scale, and regulatory oversight. At SolLabs, we practice compounding, which is a personalized healthcare service, not a large-scale production line. The primary distinction is who the medication is for. Compounding at SolLabs involves creating a medication for a single, specific patient based on a valid prescription from their doctor. In contrast, drug manufacturing is an industrial process that creates large batches of a standardized drug, often millions of doses at a time, for a general population.

• State Boards of Pharmacy: This is our primary regulatory body. As a licensed pharmacy, SolLabs is directly overseen by our State Board of Pharmacy. The board handles our licensing, conducts routine inspections of our facility, and ensures we are complying with all state-specific laws and regulations governing the practice of pharmacy and compounding.

• U.S. Food and Drug Administration (FDA): While the state boards manage day-to-day oversight, the FDA also plays a crucial role. The FDA has authority over the active pharmaceutical ingredients (APIs) we use, ensuring they are sourced from FDA-registered suppliers. Following the Drug Quality and Security Act (DQSA), the FDA's authority was clarified, and they can inspect pharmacies for cause, such as in response to a complaint or a report of an adverse event.

• United States Pharmacopeia (USP): The USP is a non-governmental, scientific organization that sets the official public standards for medication quality. While the USP does not enforce regulations itself, its chapters are legally recognized and enforced by both the State Boards of Pharmacy and the FDA. At SolLabs, we are required to strictly adhere to these standards, including:

  • USP <795>: For non-sterile preparations (e.g., creams, capsules).

  • USP <797>: For sterile preparations (e.g., injections, eye drops).

• Drug Enforcement Administration (DEA): When we compound medications that contain controlled substances (such as certain pain medications), we are also regulated by the DEA. The DEA enforces the laws and regulations related to the handling, storage, and dispensing of these substances

Check the label on your prescription. It will often state "Compounded Medication," list the specific active ingredients, and provide a "Beyond-Use Date" (BUD) instead of a manufacturer's expiration date. The packaging will also be from the pharmacy, not a commercial brand.

You always need a valid prescription from a licensed healthcare provider for any custom-compounded medication from SolLabs. Our role is to work in direct partnership with your doctor. Their prescription provides the exact formula and instructions we need to create a medication that is safe, effective, and specifically tailored to your individual health needs. We cannot dispense any compounded medication without this official directive from your provider.