Pharmacy Compounding

Compounding

Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.

Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective and made in accordance with Federal quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.

Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions of section 503A of the FDCA, although FDA retains some authority over their operations. However, outsourcing facilities that register under section 503B are regulated by FDA and must comply with CGMP requirements and will be inspected by FDA according to a risk-based schedule.

Sterile

Sterile preparations include small (less than 100 mL) and large (≥100 mL) volume parenterals which may contain one or more active ingredients intended for administration by injection or infusion, ophthalmic preparations, irrigation solutions, dialysis and allergenic extracts, diagnostic agents and surgicals. Sterile products should be free from viable microorganisms.

Non-sterile

Non-sterile preparations include topical, oral, rectal, and otic preparations.

Compounding should be performed using appropriate equipment and in a controlled room environment.

Source: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm

Pain Management Compounding

Pain is the most common reason why patients seek medical help and often to be the most difficult to treat. Pain management also called pain medicine, or algiatry is a branch of medicine employing an interdisciplinary approach to ease suffering and improve the quality of life of those in pain. Many commonly prescribed, commercially available pain relief medications help reduce the symptoms associated with chronic conditions but can result in unwanted side effects. Although patients accept these as part of their daily life, they may find better solutions through pharmacy compounding.

Pharmacists can compound products into suitable combinations, individual doses, or different delivery systems tailored specifically for each pain management need. Topical and transdermal creams and gels can be formulated to effectively relieve the precise site of pain. Flavored troches or lozenges can be prepared to provide optimal results while avoiding gastric irritation.

Sterile

Sterile preparations include small (less than 100 mL) and large (≥100 mL) volume parenterals which may contain one or more active ingredients intended for administration by injection or infusion, ophthalmic preparations, irrigation solutions, dialysis and allergenic extracts, diagnostic agents and surgicals. Sterile products should be free from viable microorganisms.

Non-sterile

Non-sterile preparations include topical, oral, rectal and otic dosage forms.

Pediatric Compounding

Taking care and giving medication to sick children can be challenging at times. They may resist taking medication, dislike the taste or texture, have difficulty swallowing solid dosage forms, and are afraid of injections. Also, variations in body size, weight, allergies and drug tolerance are added factors relating to this problem. In pediatrics, commercial medications can be limiting. Most drugs are not labeled for pediatric populations, and usually not available in suitable dosage forms.

Compounding can help solve these problems by providing appropriate alternatives. Pharmacists can compound oral medications into pleasantly flavored suspensions, solutions, concentrates or lozenges, in colors enticing to children. A palatable formulation is more likely to improve compliance and minimize spillage or waste during administration. Drugs can be compounded into transdermal gels which can be easily applied to an appropriate site for absorption through the skin.

Professional compounding is not merely diluting medications or mixing powders with bases. Physical and chemical properties of each ingredient should be considered to prepare efficient and safe customized medication with the desired properties. The efficacy of any compounded drug is influenced by the technique and equipment used in preparation, purity and quality of ingredients, choice of vehicle, and proper use of additives.

Sterile

Sterile preparations include small (less than 100 mL) and large (≥100 mL) volume parenterals which may contain one or more active ingredients intended for administration by injection or infusion, ophthalmic preparations, irrigation solutions, dialysis and allergenic extracts, diagnostic agents and surgicals. Sterile products should be free from viable microorganisms.

Non-sterile

Non-sterile preparations include topical, oral, rectal and otic dosage forms.

Cosmeceutical Compounding

Cosmeceuticals are the combination of cosmetics and pharmaceuticals. It refers to cosmetic products that contain biologically active ingredients known to be medicinal or may have drug-like benefits.

Just as each face has its distinctive features, every person has his or her unique skin type. Compounding can individualize therapy specific for a patientís need to help the skin look younger and healthier. Compounding pharmacists continue to improve both aesthetic and therapeutic aspects of customized medications, offering alternatives and advantages for dermatology. Compounded medicines can be available as cosmetically appealing creams, topical sprays, powders, and other various preparations. Compatible drugs are combined into a single dosage form to simplify medication administration and improve compliance.

Geriatric Compounding

Concerns for dosing medication in children are often same for the elderly. Aging is linked to conditions such as dry mouth that make it hard to swallow tablets and capsules. Also, most geriatric patients need to take multiple drugs in a day, in strengths lower than what is typically required for an average adult. Compounding aims to address these issues by combining multiple medications in one preparation, for ease of administration, convenience and increased compliance. Geriatric compounding solutions come in different vehicles such as oral liquids, creams, ointments, gels, rapid dissolving tablets, injections, suppositories, and many others.

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