Editorial: "New Drug," Labeling, and Label Responsibility

Executive Summary

RESPONSIBILITY FOR THE LABEL

Discussion
Compounded preparations are not "new drugs": You can't put a square peg in a round hole. This may be laborious reading, but all compounding pharmacists need to be aware of the regulatory language. Note: Due to the length of this information, some portions are omitted, but the reader is encouraged to read the complete details.

The term "new drug" means-
(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to the enactment of this Act [enacted June 25, 1938] it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) � [Emphasis added]

(m) The term "labeling" means all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.

(k) The term "label" means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm

It is quite apparent in the definition of a new drug that the emphasis is on the treatment of a condition listed in the label and that the drug must be "safe and effective" for that use described on the label.

Labeling of commercial products is approved by the FDA in the NDA process for drugs to be manufactured in the U.S. This is a good requirement and labeling is discussed in detail in the CFR 21, as follows:

Prescription drug labeling (�201.56 of 21 CFR). Requirements on content and format of labeling for human prescription drug and biological products.
(b) Categories of prescription drugs subject to the labeling content and format requirements in ��201.56(d) and 201.57. The following categories of prescription drug products are subject to the labeling requirements in paragraph (d) of this section and �201.57 in accordance with the implementation schedule in paragraph (c) of this section:
(iii) Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after June 30, 2006.

(d) Labeling requirements for new and more recently approved prescription drug products. This paragraph applies only to prescription drug products described in paragraph (b)(1) of this section and must be implemented according to the schedule specified in paragraph (c) of this section.
(1) Prescription drug labeling described in �201.100(d) must contain the specific information required under �201.57(a), (b), and (c) under the following headings and subheadings and in the following order:

Highlights of Prescribing Information
   Product Names, Other Required Information
   Boxed Warning
   Recent Major Changes
   Indications and Usage
   Dosage and Administration
   Dosage Forms and Strengths
   Contraindications
   Warnings and Precautions
   Adverse Reactions
   Drug Interactions
   Use in Specific Populations

Full Prescribing Information: Contents
Full Prescribing Information
   Boxed Warning
   1 Indications and Usage
   2 Dosage and Administration
   3 Dosage Forms and Strengths
   4 Contraindications
   5 Warnings and Precautions
   6 Adverse Reactions
   7 Drug Interactions
   8 Use in Specific Populations
     8.1 Pregnancy
     8.2 Labor and delivery
     8.3 Nursing mothers
     8.4 Pediatric use
     8.5 Geriatric use
   9 Drug Abuse and Dependence
     9.1 Controlled substance
     9.2 Abuse
     9.3 Dependence
   10 Overdosage
   11 Description
   12 Clinical Pharmacology
     12.1 Mechanism of action
     12.2 Pharmacodynamics
     12.3 Pharmacokinetics
   13 Nonclinical Toxicology
     13.1 Carcinogenesis, mutagenesis, impairment of fertility
     13.2 Animal toxicology and/or pharmacology
   14 Clinical Studies
   15 References
   16 How Supplied/Storage and Handling
   17 Patient Counseling Information

It is very apparent that the definition of a new drug requires formalized labeling approval during the NDA process. It is quite obvious that this was never intended to be applied to the compounding of patient-specific drugs.

Labeling for compounded preparations is not subject to FDA approval but is subject to the laws and regulations of the state boards of pharmacy. Since "conditions" are not a required part of a prescription drug label when dispensed, it is apparent that this definition does not cover compounded preparations.

The FDA has the responsibility for labeling for commercially produced and manufactured drugs. This labeling is on the containers up to the point of dispensing. At the point of dispensing, the State Board of Pharmacy Practice Acts takes over and the labeling is under their jurisdiction and requirements.

The FDA has the responsibility for labeling for commercial products and for materials used by pharmacists in compounding. However, when a pharmacist removes the products or materials from those containers and incorporates them into a finished compounded preparation for dispensing, it is the State Board of Pharmacy labeling that must be followed as the package/preparation is dispensed to the patient.

In summary, compounded preparations do not fit the definition of a "new drug." Square pegs and round holes just don't go together. Compounded preparations are NOT "new drugs."


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

It is the responsibility of every legal citizen in the U.S. to vote in this election; and only vote once! It is a responsibility that thousands have died for and that we should take very seriously and protect its integrity at all costs!

Tax Programs
When preparing your taxes, there are great programs that will assign values to clothing, furniture, and other items donated to charity. Use a good program�you'll be glad you did.