A significant proportion of the prescription drugs distributed in the United States is in the form of free physicians samples. Not all of these samples are used by the physicians to whom they are given. As a result, many religious, philanthropic and charitable organizations conceived the idea of collecting and distributing these and drugs from other sources for charitable purposes, especially overseas - a worthy undertaking fraught with many pitfalls and hazards. Practically all of the protective provisions of the Federal Food, Drug, and Cosmetic Act were being nullified by some of these operations.
FDA's experience showed that many of the drug samples collected from physicians and other sources were of questionable quality because of:
- Adverse storage conditions such as excessive temperature or moisture.
- Detached labeling.
- Products that had been recalled from the U.S. market for various reasons.
- The presence of investigational drugs that are not approved for use in general medical practice, and
- Other factors.
From the legal point of view, the Federal Food, Drug, and Cosmetic Act requires that a drug distributed through charitable channels be in compliance with the applicable legal provisions in the same manner as a drug distributed commercially. Initially, the Food and Drug Administration took the position that samples of drugs intended for physicians should be used only under their professional supervision and that any other disposition of physicians samples was illegal. The courts ruled, however, that so long as the samples are held in their original packages, and not repacked they are not in violation per se, by being collected and held for sale or distribution for uses other than as "physicians samples."
The controlling decision was given in an opinion by the U.S. Court of Appeals for the Third Circuit in:
U.S. vs Various Articles of Drugs (Stanack Sales Co., Inc; Kaybel, Inc.; William B. Mandell, T/a Mandell Pharmaceutcials; claimants), 3 circ., 1964 332 F.2d 286.
Following the above decision the FDA felt constrained to change its position; at the same time recommending a procedure to eliminate or minimize the risks involved in such collection programs. Questions also arose concerning the division and repacking of large bulk contributions of pharmaceuticals.
To comply with the meaning and intent of the Federal Food, Drug, and Cosmetic Act, and to insure the safety and integrity of drugs, FDA recommends the following guidelines:
- The sample drugs should be collected from the physician's office in their original unopened packages only by authorized collectors. The unopened samples should be placed in a carton, sealed, and sent to the responsible collection agency. (A responsible collection agency is one which is registered with the Food and Drug Administration; licensed by the appropriate health agency, if required, in the State in which it operates; and maintains its operations under the supervision of a registered pharmacist or licensed physician.) The drugs so collected should not be sent directly overseas.
- The responsible collection agency should, under the supervision of a registered pharmacist or licensed physician at the agency's place of business, sort and screen all samples to eliminate all recalled, outdated and investigational drugs.
- Sample drugs, after having been screened and sorted, should be sent in the original, unopened package by the agency to physicians and hospitals overseas.
- Large bulk contributions of pharmaceuticals intended for overseas shipment may be subdivided, repackaged and labeled under the supervision of a registered pharmacist or licensed physician as indicated in (1 and 2) provided proper control procedures are observed and the repackaged product complies with the Food, Drug, and Cosmetic Act.
- State laws which prohibit the operations provided for in these guidelines will take precedence - thus if a State's law prohibits the collection of physicians samples these guidelines would be inapplicable in that State.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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