What is compounding?

Compounding is the process of combining 2 or more ingredients to create a customized medication, specifically prepared for an individual. A licensed pharmacist or physician essentially creates a recipe containing many elements that must be thoroughly combined, so that a particular prescription can be used for a specific person. Compounded medications do not carry a brand name, are not available commercially, or distributed by a pharmaceutical manufacturer. They must be created by a licensed pharmacist, or licensed personnel working under the guidance of a pharmacist who compounds medication to meet an individual patient’s needs.^[2]

Who uses a compounding pharmacy?

If a patient has an allergy to a dye or formula, or their needs cannot be met through an FDA approved, commercially available medication, compounding provides a safe, effective alternative. Compounded medications can be created for any age group, including elderly patients, or children who cannot swallow pills and need a liquid delivery product. All physicians can write prescriptions for compounded medications, however most are ordered by dermatologists, pain specialists, endocrinologists, veterinarians, and gastroenterologists.^[2]

What types of medications can compounding provide?

Compounded medications can be used for a variety of medical conditions, but most often they are prescribed for patients who need a topical or oral medication for pain management, for thyroid or hormone replacement, for dermatological treatment, or for specialty suspension liquids. In general, commercial pharmacies do not have the supplies or the equipment needed to make compounded medications. Compound pharmacies combine raw ingredients to make prescription formulas for patients.

Are there any risks involved with compounded medications?

Compounded medications, while generally safe and effective, can become contaminated, tainted, or outdated, if not handled properly. Individual states oversee compounding pharmacies to ensure quality standards are met.

What laws govern compounding?

The federal Food and Drug Administration (FDA) regulates commercial pharmacies in the United States. Compounding pharmacies are also governed by both federal and state laws. Each state has specific regulations regarding standards for manufacturing, storage, record keeping, labeling, expiration dates, chain of custody, purity, sterility, and authenticity. This also includes the authority to compound ingredients into customized prescriptions for patients. Many requirements for best practices have existed for 50 years, back to an earlier time when commercial drug manufacturers did not play as big a role in drug manufacturing.^[1]

The FDA has implemented a Compounding Quality Act for registered outsourcing compounding facilities. These must meet certain recommendations and be compliant in required areas of manufacture, handling, and distribution.^[3]

Your Personal Compounding Pharmacy

In addition to commercial grade medications, our partner pharmacies meet all strict federal and state guidelines to provide safe, quality compounded formulas, customized for individual patients and therapies. As an added benefit, and to further ensure safety and efficacy, Optimal Health Pharmacy offers free follow-up hormone and bone-loss testing, for hormone therapy patients.

Natural Bioidenticals

Our partner pharmacies in the U.S. specialize in men and women’s health, with specific attention to the uncomfortable, often debilitating symptoms that accompany hormonal imbalance issues. We provide individualized, low dose, compounded medications to meet both men and women’s unique hormonal needs.

We continue to lead the field of customized prescription care through ongoing research, improved drug delivery and diagnostic testing methods. Our partner pharmacies maintain the highest standard of quality through prescription purity, accuracy, and potency.

Customization Makes our Prescriptions Unique

Your prescribing physician can choose from a variety of different strengths and delivery systems for your hormone therapy. Our relationships allow us to fill any prescription including oral capsules, sublingual tablets, topical gels and creams, and patches.

Quality Control Assures Accuracy and Purity

Unlike other compounding pharmacies that use a ‘cookbook’ approach to compound, our partner pharmacies adhere to rigorous standards, ensuring that each prescription is compounded under strict quality control methods.

Each of our partner pharmacies tests for quality using sensitive HPLC (liquid chromatography) to assure prescriptions are exactly what your doctor prescribed.

Medications are compounded for a specific healthcare provider, prescribing for a specific patient.

We compound each prescription using sophisticated pharmaceutical technology, one ingredient at a time, to assure accurate dosage delivery and a low capsule variance rate.

Our customized low-dose prescriptions use advanced, patented ingredients combined with pharmaceutical-grade chemicals.

Patient Management and Monitoring

Our reputation for excellence was built by working closely with healthcare providers to individualize low-dose, natural hormone therapy for each patient’s unique needs. Our innovative, Optimal Health Essentials Program brings together a team of registered nurses, health educators, and registered pharmacists to work with you and your healthcare provider to successfully monitor and manage even the most challenging case of hormone imbalance.

Insurance

Our customer service specialists assist with all your insurance needs and assure your prescription is delivered to your door on time.

Questions?

If you ever have questions, just a toll-free call or email.