Compounding Medicines. US Experience

Extemporaneous drugs in the United States are drugs that a pharmacist does for the special needs of patients when the pharmaceutical industry cannot do this for economic or logistical reasons.

In the United States, Chapters 795 and 797 of the Pharmacopoeia provide general information about the manufacture of medications in a pharmacy. It also validates related procedures and requirements. The international organizations such as WHO and PIC/S have done a lot to find a balance among international standards. US law clearly delineated the industrial production and manufacture of medications in a pharmacy, eliminating the need to register drugs manufactured in a pharmacy with the FDA.

Currently, the Pharmacy Councils of each state, professionally united in the National Association (NABP), create common rules for protecting public health in the manufacture of medications in pharmacies, as well as balance these standards between states.

Most often, medications compounded in a pharmacy are used in the following cases:

  • allergies to excipients contained in drugs manufactured by the pharmaceutical industry;
  • for use in pediatric practice, since the pharmaceutical industry does not always present the dosage and release forms for use in pediatrics;
  • to improve patient compliance with the treatment regimen or to obtain an additional synergistic effect;
  • for the manufacture of orphan preparations in the presence of an active ingredient that has been developed specifically for the treatment of a rare disease.
  • for the manufacture of medicines for clinical trials and placebo (only in a hospital pharmacy specially equipped for this);
  • for the manufacture of drugs with a stability problem, which may limit the industrial production of such drugs;
  • for the manufacture of drugs at the last stage of registration, only if its active substance is widely known and has already been commercialized (that is, used in other drugs);
  • for more precise “tuning” of therapy, for example, in pain treatment.

Until now, the manufacture of such medications in a pharmacy has played an important role in the United States. Despite subsidies and government benefits in the development of orphan drugs, there is still a shortage of them. Often, a drug made in a pharmacy may be the only way to get treatment.

No risks and side effects

The benefits of drugs compounded in pharmacies according to individual prescriptions are obvious. Firstly, patients are not at risk of buying a fake, receiving the drug according to the individual dosage and composition clearly defined in the prescription, taking into account age, previous diseases, and other body features, which is very important for rational treatment.

Secondly, preparations from a pharmacy do not contain stabilizers and preservatives, so the likelihood of negative side effects is minimal. In addition, the price of extemporaneous funds is formed without trade margins, which usually cover the costs of registration, packaging, advertising, etc.

Children primarily need individual medications, since the domestic market has a limited dosage form. Dosages in the manufacture of such medicine are so small that they cannot be globally produced without stabilizers and excipients. In addition, there are a lot of drugs for kids which do not even have analogs in industrial production.