Foreign establishment registration and listing. Final rule.
(25/355)
The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations pertaining to the registration of foreign establishments and the listing of human drugs, animal drugs, biological products, and devices. The final rule requires foreign establishments whose products are imported or offered for import into the United States to register with FDA and to identify a United States agent. The final rule implements section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) as it pertains to foreign establishment registration. (+info)
Amendment of regulations regarding certain label statements on prescription drugs. Final rule.
(26/355)
The Food and Drug Administration (FDA) is amending its regulations concerning certain statements that have been required on the labels of prescription drugs generally and on certain narcotic or hypnotic (habit-forming) drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). (+info)
Implementation of the Comprehensive Methamphetamine Control Act of 1996; regulation of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products and reports of certain transactions to nonregulated persons. Final rule.
(27/355)
DEA is amending its regulations to implement the requirements of the Comprehensive Methamphetamine Control Act of 1996 (MCA) with respect to the regulation of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products as List I chemicals, and the reporting of certain transactions involving pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products. The MCA removed the previous exemption from regulation as List I chemicals which had applied to pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products. This action makes persons who distribute the products subject to the registration requirement. Also, distributions, importations, and exportations of the products became subject to the existing chemical controls relating to regulated transactions, except in certain circumstances specified in the MCA. The MCA also requires that reports be submitted for certain distributions involving pseudoephedrine, phenylpropanolamine, and ephedrine (including drug products containing those chemicals) by Postal Service or private or commercial carrier to nonregulated persons. This final rule amends the regulations to make them consistent with the language of the MCA and to establish specific procedures to be followed to satisfy the new reporting requirement. DEA has, where possible, taken action to limit the public impact of these new requirements while remaining consistent with the intent of the MCA to attack the diversion of regulated drug products to the clandestine manufacture of methamphetamine. (+info)
Encouraging the use of generic medicines: implications for transition economies.
(28/355)
Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition. (+info)
International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice.
(29/355)
The Food and Drug Administration (FDA) is announcing the availability of guidance entitled "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" (M4CTD). The guidance was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is being made available simultaneously in four parts (general organization, quality, safety, and efficacy), describes a harmonized format for new product applications (including applications for biotechnology-derived products) for submission to the regulatory authorities in the three ICH regions. The M4 CTD is intended to reduce the time and resources used to compile applications, ease the preparation of electronic submissions, facilitate regulatory reviews and communication with the applicant, and simplify the exchange of regulatory information among regulatory authorities. (+info)
Low molecular weight components of polymers used in packaging.
(30/355)
The increasing use of polymers in packaging of foods and drugs focuses attention on the possible chronic toxicity relations of migrants from these polymers to the contents. Such migrants can arise from residues and additives in the polymers from manufacturing processes used in fabrication of packages. The origin and chemical nature of potential migrants, the methods of transfer, and principles involved in development of safety criteria for their regulation are discussed. (+info)
Poison prevention packaging requirements; exemption of hormone replacement therapy products. Final rule.
(31/355)
The Commission is amending its child-resistant packaging requirements to exempt hormone replacement therapy ("HRT") products containing one or more progestogen or estrogen substances. Current exemptions cover some HRT products, but not others. This rule would uniformly exempt from child resistant packaging requirements all HRT products that rely solely on the activity of one or more progestogen or estrogen substances. (+info)
Emergency hormonal contraception: the community pharmacy perspective.
(32/355)
OBJECTIVE: To explore the views of community pharmacists in the North West of England towards the deregulation of emergency hormonal contraception (EHC) and to examine their support and training needs. DESIGN: Two focus group discussions. SUBJECTS: Fourteen community pharmacists, of whom eight were currently participating in a scheme to supply EHC free of charge through a patient group direction (PGD). RESULTS: A number of themes emerged from the discussions, which appeared to influence participants' views towards the use of EHC and towards deregulation. A number of participants appeared to lack detailed knowledge about the mode of action of EHC and misunderstandings about this, coupled with erroneously held beliefs about the adverse effects of the drug, appeared to influence their attitudes to deregulation. Participants identified risks associated with pharmacy supply of EHC, both to women and to themselves, in the form of litigation. EHC was accorded a special status which seemed to go beyond its pharmacological properties and risk-benefit profile. A key and recurring theme was abuse, an ill-defined concept which appeared to refer to multiple or repeated use. It is interesting to note that none of those participants supplying EHC under a PGD could provide any examples of such abuse from their own experience. CONCLUSIONS: This small-scale study provides useful insights into the attitudes of these pharmacists towards EHC, the impact of increased availability of the drug, and the type of women who they believed would use EHC. (+info)